A Phase 2 interventional study of Capecitabine and Gemcitabine in Pancreatic Cancer, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-13.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment
The purpose of this study is to find out if a program of intensive chemotherapy with gemcitabine, docetaxel and capecitabine followed by an advanced form of focused radiation aimed at participant's tumor followed by more chemotherapy can increase the chances that the participant's pancreatic tumor can be removed completely.
Investigators plan to conduct a prospective pilot phase II trial of GTX-SBRT as neoadjuvant treatment of borderline resectable pancreatic cancer. After informed consent, pretreatment pancreatic tumor tissues will be collected and immediately frozen at the time of staging endoscopic ultrasound (EUS). Ribonucleic acid (RNA) will be extracted from tumor specimens and run on microarray analysis to determine radiosensitivity index score. Borderline resectable (BR) patients will be treated with 3 cycles of GTX chemotherapy followed by SBRT. They will be restaged and evaluated for resectability 3 to 4 weeks later. Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery.
3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.
This study's enrollment of 9 is below the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 533 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
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Patients must have histologically or cytologically confirmed pancreatic adenocarcinoma that is borderline resectable disease. Borderline resectable lesions are defined as:
Patients must have normal organ and marrow function as defined below:
Exclusion Criteria:
Gemcitabine, Taxotere, Xeloda (GTX): 21 day cycle x 3 Gemcitabine 750mg/m\^2 on days 4 and 11 Taxotere® (docetaxel) 30 mg/m\^2 on days 4 and 11 Xeloda® (capecitabine) 750 mg/m\^2 on days 1-14 Radiation: stereotactic body radiation therapy stereotactic body radiation therapy (SBRT). After radiation, participants will be re-evaluated for surgery.
Drug: Capecitabine · Drug: Gemcitabine · Drug: Docetaxel · Radiation: Stereotactic body radiation therapy (SBRT) · Other: Restaging review after radiation · Procedure: Surgery · Drug: 5-Fluorouracil
Treatment will begin with the first round of chemotherapy. Each round of chemotherapy will take 21 days. Each round or cycle will start with participants taking capecitabine pills. Participants will take tablets of capecitabine (Xeloda®) twice per day for 14 days followed by 7 days without capecitabine.
Also known as: Xeloda®
On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. First, this will consist of placing gemcitabine (Gemzar®) in a bag of fluid and giving it by vein over 30 minutes.
Also known as: Gemzar®
On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. After the gemcitabine, participants will receive docetaxel (Taxotere®) in a bag of fluid over 1 hour.
Also known as: Taxotere®
30/40 Gy to pancreatic tumor/area of borderline resectability
Also known as: SBRT
After radiation, participants will be re-evaluated for surgery. Patients who have Complete Response (CR), Partial Response (PR) or stable disease (SD) will proceed with surgical exploration and resection provided they are suitable fit for surgery in the judgment of the surgical oncologist. Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT). If no surgery: then chemotherapy. If surgery: chemotherapy will be given based on response.
Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery. After surgery, chemotherapy will be given based on response.
Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT).
Margin-negative (R0) Resection Rate
R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.
Time frame: Up to 3 years
Progression-Free Survival (PFS) at Three Years
PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.
Time frame: 3 years
Overall Survival (OS) Rate
OS at time of analysis, calculated from date of enrollment to date of death from any cause.
Time frame: 12 months
Participants were enrolled at Moffitt Cancer Center from March 2013 through December 2013.
| Milestone | Chemotherapy Followed by Radiation Treatment |
|---|---|
| Started | 9 |
| Completed | 9 |
| Not completed | 0 |
R0 rate for all participants with resection. Margin negative surgery (R0 resection) is an absolute part of the curative treatment of pancreatic cancer.The primary endpoint is correlation of a radio sensitivity index score derived from the microarray analysis and pathologic response on surgical specimens. Tumor regression Rating: R0 (Complete Response). R0 resections are scored as those resections in which the common bile duct margin, pancreatic resection margin, retroperitoneal margin are negative for tumor involvement.
| percentage of participants | Chemotherapy Followed by Radiation Treatment |
|---|---|
| Margin-negative (R0) Resection Rate | 67 |
PFS is defined as the duration of time from enrollment to time of death or progression of disease, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the longest diameter (LD) of the target lesion or appearance of new lesions at metastatic sites.
No measurements were reported for this outcome.
OS at time of analysis, calculated from date of enrollment to date of death from any cause.
| percentage of participants | All Participants -Chemotherapy Followed by Radiation Treatment | Resection Group -Chemotherapy Followed by Radiation Treatment |
|---|---|---|
| Overall Survival (OS) Rate | 33 | 100 |
Collected over 1 year, 5 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Chemotherapy Followed by Radiation Treatment | — | 4/9 (44.4%) | 9/9 (100%) |
| Event | Chemotherapy Followed by Radiation Treatment |
|---|---|
| DiarrheaGastrointestinal disorders | 2/9 |
| DehydrationMetabolism and nutrition disorders | 2/9 |
| Abdominal painGastrointestinal disorders | 1/9 |
| Mucositis oralGastrointestinal disorders | 1/9 |
| Bile duct stenosisHepatobiliary disorders | 1/9 |
| Hepatobiliary disorders - Other, Liver abscessHepatobiliary disorders | 1/9 |
| Biliary tract infectionInfections and infestations | 1/9 |
| Urinary tract infectionInfections and infestations | 1/9 |
| Alanine aminotransferase increasedInvestigations | 1/9 |
| Aspartate aminotransferase increasedInvestigations | 1/9 |
| Event | Chemotherapy Followed by Radiation Treatment |
|---|---|
| FatigueGeneral disorders | 9/9 |
| DiarheaGastrointestinal disorders | 6/9 |
| AnemiaBlood and lymphatic system disorders | 6/9 |
| ConstipationGastrointestinal disorders | 5/9 |
| AnorexiaMetabolism and nutrition disorders | 4/9 |
| HyperglycemiaMetabolism and nutrition disorders | 4/9 |
| DehydrationMetabolism and nutrition disorders | 3/9 |
| HypoalbuminemiaMetabolism and nutrition disorders | 3/9 |
| HypokalemiaMetabolism and nutrition disorders | 3/9 |
| Rash maculo-papularSkin and subcutaneous tissue disorders | 3/9 |
All participants
| Age, Categorical(Participants) | Chemotherapy Followed by Radiation Treatment |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 7 |
| Sex: Female, Male(Participants) | Chemotherapy Followed by Radiation Treatment |
|---|---|
| Female | 5 |
| Male | 4 |
| Region of Enrollment(participants) | Chemotherapy Followed by Radiation Treatment |
|---|---|
| United States | 9 |
This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute