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CompletedNCT00225784Updated Jul 16, 2014Results posted

Cetuximab, Radiotherapy and Twice Weekly Gemcitabine to Treat Pancreatic Cancer

A Phase 2 interventional study of Cetuximab/Gemcitabine and Radiotherapy in Pancreatic Cancer, sponsored by Dartmouth-Hitchcock Medical Center. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-07-16.

Sponsored by Dartmouth-Hitchcock Medical Center · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

This study is designed to establish the safety and efficacy of a combination of Erbitux (cetuximab)/Gemzar (gemcitabine)/radiation in patients with pancreatic cancer.

Read the detailed description

The study treatment for this protocol is

  • Loading dose of Cetuximab 400 mg/m2
  • Weekly Cetuximab 250 mg/m2
  • Bi-weekly Gemcitabine 50 mg/m2
  • Daily Radiation for 28 fractions
  • CT scan four weeks after completion of treatment
  • Evaluation by surgeon for resectability
02

Conditions studied

  • Pancreatic Cancer

Keywords

  • Stage I, II, III pancreatic adenocarcinoma
  • Radiographically measurable disease
03

In context

Pancreatic Neoplasms

3,236 studies on the registry are indexed under Pancreatic Neoplasms; 900 are open to participants now.

This study's enrollment of 37 is below the median of 46 across 2,425 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Dartmouth-Hitchcock Medical Center is the lead sponsor of 472 studies on the registry; 68 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 20 (67%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologic proof of pancreatic adenocarcinoma
  • Clinical stage I, II, or III disease
  • Radiographically measurable disease
  • Tumor tissue for epidermal growth factor receptor (EGFR) status by immunohistochemistry
  • Signed protocol consent
  • Karnofsky performance status of at least 70%
  • Age > or = to 18 years
  • Patients must either not be of child bearing potential or have a negative pregnancy test within 72 hours of treatment.
  • Absolute neutrophil count (ANC) > 1500; platelets > 100,000/ul.
  • Creatinine \< 1.5 x upper limit of normal (ULN)
  • Bilirubin \< 1.5 x ULN; AST \< 2.5 x ULN.

Exclusion criteria

Exclusion Criteria:

  • Acute hepatitis or known HIV
  • Active or uncontrolled infection
  • Significant history of cardiac disease
  • Prior therapy which affects or targets the EGF pathway
  • Prior severe infusion reaction to a monoclonal antibody
  • Any concurrent chemotherapy not indicated in the study protocol or any other investigational agents
  • Any previous chemotherapy or abdominal or pelvic radiotherapy
  • No prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or malignancy for which the patient has been disease free for five years.
  • Any severe pre-existing medical or psychiatric condition, which, in the opinion of the attending physician, will interfere with safe and appropriate treatment and follow-up on study
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Experimental
    Cetuximab, Gemcitabine, RT

    weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy

    Drug: Cetuximab/Gemcitabine · Procedure: Radiotherapy

Interventions

  • DrugCetuximab/Gemcitabine

    Once weekly Cetuximab, twice weekly Gemcitabine for six weeks

    Also known as: Erbitux

  • ProcedureRadiotherapy

    Daily radiotherapy for 28 days

06

What researchers measure

Primary outcomes

  1. Objective Response of Tumor by RECIST 1.0 Criteria

    Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), \>=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.

    Time frame: one month post-therapy

Secondary outcomes

  1. Number of Participants Assessed for Adverse Events

    Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0

    Time frame: Participants were followed during treatment and for 30 days after completion of treatment

  2. Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy

    Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).

    Time frame: 1 month after completion of treatment

  3. Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.

    Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.

    Time frame: One month post-therapy

  4. Disease-Free Survival After Therapy

    Time to disease progression after therapy.

    Time frame: Five years post treatment

  5. Overall Length of Survival After Therapy

    Length of survival after therapy in all participants enrolled.

    Time frame: Five years post treatment

  6. Pattern of Failure After Therapy

    Local recurrence, distant recurrence, or both.

    Time frame: Five years post treatment

07

Results

Posted Apr 18, 2013
Limitations and caveats
Our study suffers limitations common to single institution trials, namely small patient numbers and selection bias. Our cohort of subjects is too small to adequately assess the effect of tumor EGFR and KRAS status on outcome.

Participant flow

This was a single-institution study of weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with pancreatic ductal adenocarcinoma conducted at Dartmouth-Hitchcock.

Participant flow — Overall Study
MilestoneCetuximab, Gemcitabine, Radiotherapy
Started37
Completed33
Not completed4

Outcome measures

PrimaryObjective Response of Tumor by RECIST 1.0 Criteria

Per RECIST Criteria (v. 1.0) and assessed by CT scan: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in sum of the longest diameter (SLD)of target lesions at baseline; Progressive Disease (PD), \>=20% increase in the SLD of target lesions at baseline; Stable Disease (SD), Neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD.

Time frame:
one month post-therapy
Reported as:
Number · participants
Objective Response of Tumor by RECIST 1.0 Criteria
participantsCetuximab, Gemcitabine, Radiotherapy
partial response10
stable disease20
progressive disease3
SecondaryNumber of Participants Assessed for Adverse Events

Adverse events assessed using Common Terminology Criteria for Adverse Events version 3.0

Time frame:
Participants were followed during treatment and for 30 days after completion of treatment
Reported as:
Number · participants
Number of Participants Assessed for Adverse Events
participantsCetuximab, Gemcitabine, Radiotherapy
Number of Participants Assessed for Adverse Events37
SecondaryNumber of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy

Tumor resectability is based on CT scan and as defined by the American Hepato-Pancreato-Biliary Association Convened Consensus Conference on Resectable and Borderline Resectable Pancreatic Cancer (Callery MP, et al. Ann Surg Oncol 2009; 16:1727-1733): no evidence of superior mesenteric vein (SMV) or portal vein (PV)abutment, distortion, tumor thrombus, or venous encasement, and clear fat planes around celiac axis (CA), hepatic artery (HA), and superior mesenteric artery (SMA).

Time frame:
1 month after completion of treatment
Reported as:
Number · participants
Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy
participantsCetuximab, Gemcitabine, Radiotherapy
Number of Participants Determined to be Resectable (Eligible for Surgery)After Completion of Therapy26
SecondaryRole of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.

Tumor was assessed for EGFR status by immunohistochemistry. EGFR positive and EGRF negative tumor types were evaluated and compared for response to treatment.

Time frame:
One month post-therapy
Reported as:
Number · percent
Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.
percentCetuximab, Gemcitabine, Radiotherapy in EGFR (-) TumorsCetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors
Role of Epidermal Growth Factor Receptor (EGFR) Status in Response to Treatment.3329
SecondaryDisease-Free Survival After Therapy

Time to disease progression after therapy.

Time frame:
Five years post treatment
Reported as:
Median · months
Disease-Free Survival After Therapy
monthsCetuximab, Gemcitabine, Radiotherapy
Disease-Free Survival After Therapy9.1 (2 to NA)
SecondaryOverall Length of Survival After Therapy

Length of survival after therapy in all participants enrolled.

Time frame:
Five years post treatment
Reported as:
Median · months
Overall Length of Survival After Therapy
monthsCetuximab, Gemcitabine, Radiotherapy
Overall Length of Survival After Therapy17.3 (2 to NA)
SecondaryPattern of Failure After Therapy

Local recurrence, distant recurrence, or both.

Time frame:
Five years post treatment
Reported as:
Number · participants
Pattern of Failure After Therapy
participantsCetuximab, Gemcitabine, Radiotherapy
number of participants with local recurrence only2
number of ppts. with local and distant recurrence1
number of ppts. with distant disease recurrence17
number of ppts. without recurrence or unknown5

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cetuximab/Gemcitabine/Radiotherapy—22/33 (66.7%)—
Most frequent serious events
Most frequent serious events
EventCetuximab/Gemcitabine/Radiotherapy
NeutropeniaBlood and lymphatic system disorders22/33
Nausea/VomitingGastrointestinal disorders9/33
Gastrointestinal disorder - stent obstructionGastrointestinal disorders8/33
Gastritis/GI BleedGastrointestinal disorders5/33
FatigueGeneral disorders4/33
CNS IschemiaNervous system disorders2/33
Deep vein thrombosisVascular disorders2/33
AnemiaInvestigations1/33
Hematoma subduralNervous system disorders1/33
Pain - gouty arthritisMusculoskeletal and connective tissue disorders1/33
Most frequent other events
Most frequent other events
EventCetuximab/Gemcitabine/Radiotherapy
Anaphylaxtic reaction to erbituxImmune system disorders3/37

Baseline characteristics

Age, Continuous
Age, Continuous(years)Cetuximab/Gemcitabine/Radiotherapy
Between 18 and 65 years54.7 (39 to 65)
>=65 years73.1 (67 to 82)
Sex: Female, Male
Sex: Female, Male(Participants)Cetuximab/Gemcitabine/Radiotherapy
Female21
Male16
08

Study locations

No study locations are listed for this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00225784
Lead sponsor
Dartmouth-Hitchcock Medical Center
Responsible party
Sponsor
First posted
Sep 26, 2005
Start date
Feb 2005
Primary completion
Feb 2010
Completion
Sep 2012
Results posted
Apr 18, 2013
Last update
Jul 16, 2014

Study contacts

J Marc Pipas, MD
principal investigator · Dartmouth-Hitchcock Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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