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CompletedNCT01294358Updated Nov 13, 2019Results posted

Regional Chemotherapy in Locally Advanced Pancreatic Cancer: RECLAP Trial

A Phase 1 interventional study of Gemcitabine in Histologically or Cytologically Confirmed Pancreatic Ca and Unresectable or Borderline Resectable Pancreatic Ca, sponsored by National Cancer Institute (NCI). Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2019-11-13.

Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
7
Allocation
Not applicable
Ages
18 Years to 99 Years
Sex
All
01

Study summary

Background:

  • Pancreatic cancer is difficult to treat because by the time most cases are diagnosed, the tumors are too large to be removed surgically. Standard intravenous chemotherapy may shrink some of the tumor, but even with chemotherapy only about 25 percent of patients will live for 1 year following diagnosis. Several preliminary studies have shown that it is safe to give chemotherapy directly into the pancreas in the area of the tumor, and that giving gemcitabine over a longer period increases the amount of drug that is available to the tumor. Researchers are interested in studying whether giving the approved pancreatic cancer chemotherapy drug gemcitabine directly into the pancreas in the area of the cancer and at a slow rate of infusion is a safe and effective treatment.

Objectives:

  • To test the safety and effectiveness of administering gemcitabine directly to a pancreatic tumor at a slow rate of infusion.

Eligibility:

  • Individuals at least 18 years of age who have been diagnosed with pancreatic cancer that is currently too large to be removed surgically but has not yet spread to other organs.

Design:

  • Participants will be screened with a full medical history and physical examination, blood and urine tests, and imaging studies.
  • Participants will undergo pancreatic angiography and embolization, during which a catheter will be threaded into the blood vessels near the pancreas and a contrast dye will be used to show the blood vessels supplying the tumor. These blood vessels will then be surgically closed off.
  • After the embolization, gemcitabine will be given as an infusion into the area around the tumor over 24 hours.
  • Participants will return to the clinical center every 2 weeks after the first infusion for additional infusions of gemcitabine, using the same procedures as above. Participants will be monitored with frequent blood tests and imaging studies.
  • Two weeks after the fourth treatment (course 1), participants will have more imaging studies, a physical examination, and blood tests. If the tumor is shrinking, participants will have two more courses of treatment (eight more infusions of gemcitabine).
  • Participants will have followup visits every 3 months for 2 years following the last treatment and then every 6 months.
Read the detailed description

Background:

  • Pancreatic cancer is the fourth leading cause of cancer death in the United States.
  • Surgery offers the only chance at cure; however, less than 20% of patients are considered resectable at initial presentation.
  • A common reason for being classified as unresectable is loco-regional advanced disease.
  • Several phase I studies of regional administration of chemotherapy have proven safe.
  • The main advantage of pancreatic cancer targeted arterial perfusion of Gemcitabine is achievement of higher local bio-available active drug levels at the tumor bed.
  • The Regional Chemotherapy in Locally Advanced Pancreatic Cancer (RECLAP) trial is a phase I trial offering highly selective 24-hour intra-arterial administration of Gemcitabine via a subcutaneous port for patients with unresectable locally-advanced pancreatic cancer.

Objectives:

Primary Objective:

  • To evaluate feasibility and toxicity of intra-arterial gemcitabine therapy (dose limiting toxicity (DLT)).
  • To establish the maximum tolerated dose (MTD)

Secondary Objectives:

  • To evaluate response rate using Response Evaluation Criteria in Solid Tumors (RECIST), positron emission tomography (PET), magnetic resonance imaging (MRI) and computed tomography (CT) perfusion criteria (European Association for the Study of the Liver (EASL))
  • To determine progression free and overall survival.
  • To evaluate the conversion rate from unresectable or borderline resectable to potentially resectable pancreatic cancer.
  • To determine progression-free and overall survival.
  • To analyze potential selection criteria to be used in future studies for patients who present with marginally unresectable or unresectable locally-advanced pancreatic cancer that might benefit from this approach.

Eligibility:

  • Unresectable locally-advanced pancreatic cancer.
  • 18 years old or greater with an Eastern Cooperative Oncology Group (ECOG) 0-2
  • Laboratory and physical examination parameters within acceptable limits by standard of practice guidelines prior to surgery or chemotherapy.
  • No extra-pancreatic disease except regional lymph nodes.

Design:

  • This is a dose escalation phase-I study.
  • Patients considered unresectable due to locally-advanced pancreatic cancer will receive selective arterial perfusion of gemcitabine over 24 hours via a subcutaneous indwelling port.
  • Treatment will be given on Days 1 and 14. One cycle = 4 weeks for up to six cycles.
  • Three to six patients will be enrolled per dose cohort.
  • 18 to 36 patients in 7 cohorts will be accrued plus 6 more patients at the maximum tolerated dose (MTD over 36 months. Patients will be evaluated every 2 cycles (8 weeks). Upon progression patients will be taken off study. If no progressive disease (PD), patients will continue up to 6 cycles.
  • Chemotherapy na(SqrRoot) ve patients and patients who received previously chemotherapy including gemcitabine will be allowed, as this mode of administration has better bioavailability, offer potential for better biological effect and less systemic toxicity profiles.
02

Conditions studied

  • Histologically or Cytologically Confirmed Pancreatic Ca
  • Unresectable or Borderline Resectable Pancreatic Ca

Keywords

  • Pancreatic Cancer
  • Regional Therapy
  • Selective Arterial Infusion
  • Locally Advanced Disease
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's enrollment of 7 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.

Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically or cytologically confirmed locally advanced pancreatic adenocarcinoma or clinical and radiographic evidence of pancreatic cancer

Note: Patients with a limited disease burden outside the pancreas, who have undergone systemic chemotherapy for metastatic disease and have achieved a complete response on the metastatic lesions of greater than or equal to 6 months, and have no evidence of disease outside the pancreas at time of enrollment, are eligible.

  • Disease must be evaluable
  • Disease should be deemed unresectable by the MD Anderson criteria
  • Patients may be chemo naive or have received prior chemotherapy (including Gemcitabine) and/or radiation
  • Greater than or equal to 18 years of age
  • Must be able to understand and sign the Informed Consent Document
  • Clinical performance status of Eastern Cooperative Oncology Group (ECOG) less than or equal to 2
  • Life expectancy of greater than three months
  • Patients of both genders must be willing to practice birth control during and for four months after receiving chemotherapy

  • Hematology:

    • Absolute neutrophil count greater than 1300/mm(3) without the support of Filgrastim.
    • Platelet count greater than 75,000/mm(3).
    • Hemoglobin greater than 8.0 g/dl.

  • Chemistry:

    • Serum alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less or equal to 3 times the upper limit of normal, unless patient carries a biliary stent. For these patients, to account for asymptomatic, transient elevations in transaminases ('transaminitis'), serum ALT/AST may be less than or equal to 5 times the upper limit of normal provided all other eligibility parameters are met.
    • Serum creatinine less than or equal to 1.8 mg/dl unless the measured creatinine clearance is greater than 60 mL/min/1.73 m(2)
    • Total bilirubin less than or equal to 2 mg/dl,
    • Prothrombin time (PT) within 2 seconds of the upper limit of normal or International Normalized Ratio (INR) less than or equal to 1.8
  • No history of prior/other malignancies within the 2 years prior to enrollment with the exception of basal cell carcinoma

Exclusion criteria

EXCLUSION CRITERIA:

  • Metastatic disease including malignant ascites
  • Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the chemotherapy on the fetus or infant.
  • Active systemic infections, coagulation disorders or other major medical illnesses of the cardiovascular, respiratory or immune system, myocardial infarction, heart failure
  • Childs B or C cirrhosis or with evidence of severe portal hypertension by history, endoscopy, or radiologic studies
  • Weight less than 40 kg
  • Significant ascites, greater than 1000cc in the absence of peritoneal disease
  • Concomitant medical problems that would place the patient at an unacceptable risk for the procedure
  • Need for concurrent chemotherapy
  • Discretion of the principal investigator (PI)
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
7 participants (actual)

Study arms

  • Experimental
    Gemcitabine Dose Escalation

    gemcitabine dose escalation

    Drug: Gemcitabine

Interventions

  • DrugGemcitabine

    Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.

    Also known as: Gemzar

06

What researchers measure

Primary outcomes

  1. Number of Participants With Dose Limiting Toxicity (DLT )

    Here is the number of participants with DLT. DLT is defined as follows: All grade 3 or greater toxicities with the exception of Grade 3 constitutional symptoms that persist for less than 72 hours, Grade 3 and 4 myelosuppression (neutrophils and thrombocytopenia) of less than 5 days duration. Grade 3 metabolic/laboratory events that are correctable within 24 hours. Events that are assessed by the principal investigator as clearly unrelated to the agent will not be considered DLTs (e.g., events directly related to catheter insertion, pain related to underlying disease).

    Time frame: Cycle 1 (4 weeks), for up to 6 cycles

  2. MTD (Maximum Tolerated Dose)

    The MTD is the highest dose that induces dose limiting toxicity (DLT) in no more than 2 patients among a cohort of 6 patients. If 1 or fewer patients experience dose limiting toxicity than the dose level will define the MTD. Only DLT's that occurred during cycle 1 of each dose level were used to determine the MTD.

    Time frame: Cycle 1 (4 weeks), for up to 6 cycles

Secondary outcomes

  1. Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

    Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.

    Time frame: Every 2 cycles (8 weeks), up to 18 weeks

  2. Response Rate Using Positron Emission Tomography (PET)

    Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.

    Time frame: Every 2 cycles (8 weeks), up to 18 weeks

  3. Response Rate Using Magnetic Resonance Imaging (MRI)

    Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.

    Time frame: Every 2 cycles (8 weeks), up to 18 weeks

  4. Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1)

    Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.

    Time frame: Every 2 cycles (8 weeks), up to 18 weeks

  5. Median Time to Progression

    Time to progression is the time between the first day of treatment to the day of disease progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions.

    Time frame: From first day of treatment to the day of progression, assessed up to 221 months

  6. Median Overall Survival (OS)

    Overall survival is defined as the time between the first day of treatment to the day of death.

    Time frame: Overall survival was assessed through study completion, an average of 3 years.

  7. Number of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer

    Resectability is defined by the MD Anderson Resectability criteria: Resectable is no extension; normal fat plane between the tumor and the artery (superior mesenteric artery (SMA)). No extension (celiac axis/hepatic artery). Patent (superior mesenteric vein/portal vein (SMV/PV)). Borderline resectable is tumor abutment ≤180◦ (one half or less) of the circumference of the artery; periarterial stranding and tumor points of contact forming a convexity against the vessel improve chances of resection (SMA). Short-segment encasement/abutment of the common hepatic artery (typically at the gastroduodenal origin) (celiac axis/hepatic artery). Short-segment occlusion with suitable vessel above and below (SMV/PV). Locally advanced is encased (\>180◦) (SMA). Encased and no technical option for reconstruction usually because of extension to the celiac axis/splenic/left gastric junction or the celiac origin (celiac axis/hepatic artery). Occluded and no technical option for reconstruction (SMV/PV).

    Time frame: 4 months

  8. Number of Potential Selection Criteria to Be Used in Future Studies for Patients With Marginally Unresectable Or Unresectable Locally-Advanced Pancreatic Cancer

    Number of selection criteria that can be used for unresectable pancreatic cancer.

    Time frame: up to 2.5 years

  9. Number of Participants With Serious and Non-Serious Adverse Events

    Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned

    Time frame: Date treatment consent signed to date off study, approximately 2 years and 2 months and 21 days

07

Results

Posted Oct 1, 2018

Participant flow

Cohort 1: 5/11/11-11/9/11
Participant flow — Cohort 1: 5/11/11-11/9/11
Milestone18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h.
Started40000
Completed40000
Not completed00000
Cohort 2: 6/9/11-9/17/12
Participant flow — Cohort 2: 6/9/11-9/17/12
Milestone18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h.
Started06000
Completed04000
Not completed02000
Withdrew: Disease progression02000
Cohort 3: 12/1/11-10/6/12
Participant flow — Cohort 3: 12/1/11-10/6/12
Milestone18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h.
Started00400
Completed00200
Not completed00200
Withdrew: Disease progression00200
Cohort 4: 12/30/11-2/17/17
Participant flow — Cohort 4: 12/30/11-2/17/17
Milestone18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h.
Started00020
Completed00010
Not completed00010
Withdrew: Pt rec'd surgical resection of pancreas00010
Cohort 5: 3/8/12-3/9/12
Participant flow — Cohort 5: 3/8/12-3/9/12
Milestone18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h.
Started00001
Completed00000
Not completed00001
Withdrew: Dose limiting toxicity grade 400001

Outcome measures

PrimaryNumber of Participants With Dose Limiting Toxicity (DLT )

Here is the number of participants with DLT. DLT is defined as follows: All grade 3 or greater toxicities with the exception of Grade 3 constitutional symptoms that persist for less than 72 hours, Grade 3 and 4 myelosuppression (neutrophils and thrombocytopenia) of less than 5 days duration. Grade 3 metabolic/laboratory events that are correctable within 24 hours. Events that are assessed by the principal investigator as clearly unrelated to the agent will not be considered DLTs (e.g., events directly related to catheter insertion, pain related to underlying disease).

Time frame:
Cycle 1 (4 weeks), for up to 6 cycles
Reported as:
Count of participants · Participants
Number of Participants With Dose Limiting Toxicity (DLT )
Participants18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h
Number of Participants With Dose Limiting Toxicity (DLT )01000
PrimaryMTD (Maximum Tolerated Dose)

The MTD is the highest dose that induces dose limiting toxicity (DLT) in no more than 2 patients among a cohort of 6 patients. If 1 or fewer patients experience dose limiting toxicity than the dose level will define the MTD. Only DLT's that occurred during cycle 1 of each dose level were used to determine the MTD.

Time frame:
Cycle 1 (4 weeks), for up to 6 cycles
Reported as:
Number · mg/ml/24h
MTD (Maximum Tolerated Dose)
mg/ml/24hGemcitabine Dose Escalation
MTD (Maximum Tolerated Dose)115
SecondaryResponse Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.

Time frame:
Every 2 cycles (8 weeks), up to 18 weeks
Reported as:
Count of participants · Participants
Response Using the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.
Participants18 mg/m(2)/24h,36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h
Complete response (CR)00000
Partial response (PR)00000
Stable disease44220
Progressive disease (PD)02201
SecondaryResponse Rate Using Positron Emission Tomography (PET)

Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.

Time frame:
Every 2 cycles (8 weeks), up to 18 weeks

No measurements were reported for this outcome.

SecondaryResponse Rate Using Magnetic Resonance Imaging (MRI)

Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.

Time frame:
Every 2 cycles (8 weeks), up to 18 weeks

No measurements were reported for this outcome.

SecondaryResponse Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1)

Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters. Progression is at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions. Stable disease is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum diameters while on study.

Time frame:
Every 2 cycles (8 weeks), up to 18 weeks
Reported as:
Count of participants · Participants
Response Using Computed Tomography (CT) Perfusion Criteria European Association for the Study of the Liver (EASL1)
Participants18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h
Complete response (CR)00000
Partial response (PR)00000
Progressive disease (PD)04220
Stable disease (SD)42201
SecondaryMedian Time to Progression

Time to progression is the time between the first day of treatment to the day of disease progression. Progression is defined as at least a 20% increase in the sum of diameters of target lesions taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study) or the appearance of one or more new lesions.

Time frame:
From first day of treatment to the day of progression, assessed up to 221 months
Reported as:
Median · Months
Median Time to Progression
MonthsGemcitabine Dose Escalation
Median Time to Progression2 (1 to 221)
SecondaryMedian Overall Survival (OS)

Overall survival is defined as the time between the first day of treatment to the day of death.

Time frame:
Overall survival was assessed through study completion, an average of 3 years.
Reported as:
Median · Months
Median Overall Survival (OS)
Months18 mg/m(2)/24h,36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h
Median Overall Survival (OS)NA (NA to NA)9 (3 to 15)9 (3 to 16)15 (0 to 15)NA (NA to NA)
SecondaryNumber of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer

Resectability is defined by the MD Anderson Resectability criteria: Resectable is no extension; normal fat plane between the tumor and the artery (superior mesenteric artery (SMA)). No extension (celiac axis/hepatic artery). Patent (superior mesenteric vein/portal vein (SMV/PV)). Borderline resectable is tumor abutment ≤180◦ (one half or less) of the circumference of the artery; periarterial stranding and tumor points of contact forming a convexity against the vessel improve chances of resection (SMA). Short-segment encasement/abutment of the common hepatic artery (typically at the gastroduodenal origin) (celiac axis/hepatic artery). Short-segment occlusion with suitable vessel above and below (SMV/PV). Locally advanced is encased (\>180◦) (SMA). Encased and no technical option for reconstruction usually because of extension to the celiac axis/splenic/left gastric junction or the celiac origin (celiac axis/hepatic artery). Occluded and no technical option for reconstruction (SMV/PV).

Time frame:
4 months
Reported as:
Count of participants · Participants
Number of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer
Participants18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h.115 mg/m(2)/24h
Number of Participants Who Converted From Unresectable or Borderline Resectable To Potentially Resectable Pancreatic Cancer00011
SecondaryNumber of Potential Selection Criteria to Be Used in Future Studies for Patients With Marginally Unresectable Or Unresectable Locally-Advanced Pancreatic Cancer

Number of selection criteria that can be used for unresectable pancreatic cancer.

Time frame:
up to 2.5 years

No measurements were reported for this outcome.

SecondaryNumber of Participants With Serious and Non-Serious Adverse Events

Here is the count of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned

Time frame:
Date treatment consent signed to date off study, approximately 2 years and 2 months and 21 days
Reported as:
Count of participants · Participants
Number of Participants With Serious and Non-Serious Adverse Events
Participants18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h115 mg/m(2)/24h
Number of Participants With Serious and Non-Serious Adverse Events45321

Adverse events

Collected over Date treatment consent signed to date off study, approximately years, 2 months and 21 days.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
18 mg/m(2)/24h0/4 (0%)0/4 (0%)3/4 (75%)
36 mg/m(2)/24h2/6 (33.3%)1/6 (16.7%)5/6 (83.3%)
72 mg/m(2)/24h2/4 (50%)0/4 (0%)2/4 (50%)
96 mg/m(2)/24h.1/2 (50%)2/2 (100%)1/2 (50%)
115 mg/m(2)/24h0/1 (0%)1/1 (100%)1/1 (100%)
Most frequent serious events
Most frequent serious events
Event18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h.115 mg/m(2)/24h
Abdominal infectionInfections and infestations0/40/60/40/21/1
AnemiaBlood and lymphatic system disorders0/41/60/42/21/1
DepressionPsychiatric disorders0/40/60/40/21/1
Duodenal ulcerGastrointestinal disorders0/40/60/40/21/1
GastroparesisGastrointestinal disorders0/40/60/40/21/1
HypoalbuminemiaMetabolism and nutrition disorders0/40/60/40/21/1
Alanine aminotransferase increasedInvestigations0/40/60/41/20/1
Aspartate aminotransferase increasedInvestigations0/40/60/41/20/1
Blood bilirubin increasedInvestigations0/40/60/41/20/1
FatigueGeneral disorders0/41/60/40/20/1
Most frequent other events
Showing 10 of 20
Most frequent other events
Event18 mg/m(2)/24h36 mg/m(2)/24h72 mg/m(2)/24h96 mg/m(2)/24h.115 mg/m(2)/24h
Alkaline phosphatase increasedInvestigations2/44/60/40/21/1
AnemiaBlood and lymphatic system disorders0/41/60/40/21/1
Blood bilirubin increasedInvestigations0/40/60/40/21/1
FatigueGeneral disorders2/42/61/41/21/1
HallucinationsPsychiatric disorders0/40/60/40/21/1
Lymphocyte count decreasedInvestigations1/42/61/41/21/1
FeverGeneral disorders0/40/60/41/20/1
HypokalemiaMetabolism and nutrition disorders0/40/60/41/20/1
Surgical and medical procedures - Other, retained foreign bodySurgical and medical procedures0/40/60/41/20/1
Abdominal painGastrointestinal disorders1/41/60/40/20/1

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)All Participants
<=18 years0
Between 18 and 65 years2
>=65 years5
Age, Continuous
Age, Continuous(years)All Participants
Mean67.57 ± 6.2
Sex: Female, Male
Sex: Female, Male(Participants)All Participants
Female4
Male3
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)All Participants
Hispanic or Latino0
Not Hispanic or Latino7
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)All Participants
American Indian or Alaska Native0
Asian0
Native Hawaiian or Other Pacific Islander0
Black or African American1
White6
More than one race0
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)All Participants
United States7
Time from Diagnosis to Trial Enrollment
Time from Diagnosis to Trial Enrollment(Months)All Participants
Median8.5 (5 to 16)
Serum CA 19-9 Level at the Time of Enrollment
Serum CA 19-9 Level at the Time of Enrollment(Units/ml)All Participants
Median133 (1.0 to 521.0)
08

Study locations

1 site
  • National Institutes of Health Clinical Center, 9000 Rockville Pike
    Bethesda, Maryland 20892, United States
09

References and documents

Publications

  • Bruix J, Sherman M, Llovet JM, Beaugrand M, Lencioni R, Burroughs AK, Christensen E, Pagliaro L, Colombo M, Rodes J; EASL Panel of Experts on HCC. Clinical management of hepatocellular carcinoma. Conclusions of the Barcelona-2000 EASL conference. European Association for the Study of the Liver. J Hepatol. 2001 Sep;35(3):421-30. doi: 10.1016/s0168-8278(01)00130-1. No abstract available. PubMed 11592607 ↗
  • Jemal A, Siegel R, Ward E, Hao Y, Xu J, Thun MJ. Cancer statistics, 2009. CA Cancer J Clin. 2009 Jul-Aug;59(4):225-49. doi: 10.3322/caac.20006. Epub 2009 May 27. PubMed 19474385 ↗
  • Sener SF, Fremgen A, Menck HR, Winchester DP. Pancreatic cancer: a report of treatment and survival trends for 100,313 patients diagnosed from 1985-1995, using the National Cancer Database. J Am Coll Surg. 1999 Jul;189(1):1-7. doi: 10.1016/s1072-7515(99)00075-7. PubMed 10401733 ↗
  • Davis JL, Pandalai P, Ripley RT, Langan RC, Steinberg SM, Walker M, Toomey MA, Levy E, Avital I. Regional chemotherapy in locally advanced pancreatic cancer: RECLAP trial. Trials. 2011 May 19;12:129. doi: 10.1186/1745-6215-12-129. PubMed 21595953 ↗

Study documents

  • Study protocol · Nov 15, 2012
  • Informed consent form · Nov 15, 2012

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 13, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01294358
Lead sponsor
National Cancer Institute (NCI)
Responsible party
Udo Rudloff, M.D. (Principal Investigator, National Cancer Institute (NCI)) — Principal investigator
First posted
Feb 11, 2011
Start date
Jan 26, 2011
Primary completion
Jul 23, 2014
Completion
Jul 23, 2014
Results posted
Oct 1, 2018
Last update
Nov 13, 2019

Study contacts

Udo Rudloff, M.D.
principal investigator · National Cancer Institute (NCI)

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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