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2008-02
2013-02
2014-09
820
NCT00634725
GERCOR - Multidisciplinary Oncology Cooperative Group
GERCOR - Multidisciplinary Oncology Cooperative Group
INTERVENTIONAL
Gemcitabine With or Without Capecitabine and/or Radiation Therapy or Gemcitabine With or Without Erlotinib in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed by Surgery
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Radiation therapy uses high-energy x-rays to kill tumor cells. It is not yet known which regimen of chemotherapy with or without erlotinib and/or radiation therapy is most effective in treating pancreatic cancer. PURPOSE: This randomized phase III trial is studying giving gemcitabine together with or without capecitabine and/or radiation therapy to see how well it works compared with giving gemcitabine together with or without erlotinib in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.
OBJECTIVES: Primary * To assess whether administrating chemoradiotherapy in patients whose tumor is controlled after 4 months of induction chemotherapy (CT) increases survival compared with continuation of the same CT in patients with unresectable, locally advanced adenocarcinoma of the pancreas. Secondary * To assess whether erlotinib hydrochloride combined with gemcitabine hydrochloride and administered as maintenance treatment increases progression-free survival compared with gemcitabine hydrochloride alone and without maintenance treatment. * To evaluate the response rate in the CT and chemoradiotherapy (CRT) arms. * To evaluate tolerance to erlotinib hydrochloride as maintenance treatment after the end of CT or CRT. * To study the predictive molecular factors (i.e., survivin, K-ras, EGFR, PTEN, or AKT) of survival. OUTLINE: This is a multicenter study. Patients in the first randomization are stratified according to center and ECOG performance status (0-1 vs 2). Patients in the second randomization are stratified according to center and initial treatment arm (I vs II). * First randomization: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Following the first evaluation, patients continue to receive gemcitabine hydrochloride on days 57, 64, 71, 85, 92, and 99 for a total of 4 months. * Arm II: Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43. Following the first evaluation, patients continue to receive gemcitabine hydrochloride on days 57, 64, 71, 85, 92, and 99. Patients also receive oral erlotinib hydrochloride once daily for 4 months. After completion of treatment in the first randomization proceed to the second randomization. * Second randomization: Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients continue gemcitabine hydrochloride as in arm I in the first randomization on days 113, 120, and 127 and on days 141, 148, and 155 for 2 months in the absence of disease progression. * Arm II: Patients continue gemcitabine hydrochloride as in arm II in the first randomization on days 113, 120, and 127 and on days 141, 148, and 155 and oral erlotinib hydrochloride daily for 2 months followed by erlotinib hydrochloride alone as maintenance therapy in the absence of disease progression. * Arm III: Patients receive oral capecitabine twice daily and undergo radiotherapy beginning on day 127, 5 days a week, for 6 weeks, in the absence of disease progression. * Arm IV: Patients receive oral capecitabine twice daily and undergo radiotherapy beginning on day 127, 5 days a week, for 6 weeks. Beginning 15 days after completion of CRT, patients receive a reintroduction of oral erlotinib hydrochloride alone once daily in the absence of disease progression or unacceptable toxicity. Tumor tissue will be analyzed for the relationship between biological markers and resistance to treatment. After completion of study treatment, patients are followed every 2 months.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2008-03-12 | N/A | 2015-12-10 |
2008-03-12 | N/A | 2015-12-11 |
2008-03-13 | N/A | 2012-11 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| ACTIVE_COMPARATOR: Arm 1 (A1) - Gemcitabine Gemcitabine 2 months, then stop until progression | DRUG: gemcitabine hydrochloride OTHER: laboratory biomarker analysis |
| EXPERIMENTAL: Arm 2 (B1) Gemcitabine + Erlotinib B1 Gemcitabine + Erlotinib (100mg/d) 2 months, then erlotinib maintenance (150 mg/d)until progression | DRUG: erlotinib hydrochloride DRUG: gemcitabine hydrochloride OTHER: laboratory biomarker analysis |
| EXPERIMENTAL: Arm 3 (A2) CRT A2 CRT then stop until progression | DRUG: capecitabine OTHER: laboratory biomarker analysis RADIATION: radiation therapy |
| EXPERIMENTAL: Arm 4 (B2) CRT then erlotinib B2 CRT then erlotinib maintenance (150mg/d) until progression | DRUG: capecitabine DRUG: erlotinib hydrochloride OTHER: laboratory biomarker analysis RADIATION: radiation therapy |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Overall survival | an interim analysis is planned when 196 deaths will be observed | from the date of the first randomization to the date of patient death,due to any cause, or to the last date the patient was known to be alive, assessed up to 8 years after the beginning of the study |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Progression-free survival | time from the date of the first randomization to the date of progressive disease or death, assessed up to 8 years after the beginning of the study. | |
| Relationship between biological markers and survival | 1 biopsy/patient of the pancreas before treatment | From baseline to death, assessed up to 8 years after the beginning of the study |
| tolerance to erlotinib | To evaluate tolerance to erlotinib as maintenance treatment after the end of CT or CRT. During each visit, any adverse events will be noted and graded according to version 3 of the NCI-CTCAE. Any adverse events that persist at the end of the CTI will be followed up until they disappear. | from start of treatment until the event has resolved or stabilized or until death |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
