Gemcitabine and Oxaliplatin Followed By Radiation Therapy, Fluorouracil, and Oxaliplatin in Treating Patients With Locally Advanced Pancreatic Cancer That Cannot Be Removed By Surgery

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine, oxaliplatin, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with oxaliplatin followed by radiation therapy, fluorouracil, and oxaliplatin works in treating patients with locally advanced pancreatic cancer that cannot be removed by surgery.

Detailed Description
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OBJECTIVES: Primary Compare progression-free survival of patients with locally advanced, nonresectable adenocarcinoma of the pancreas treated with gemcitabine hydrochloride and oxaliplatin followed by concurrent radiotherapy, fluorouracil, and oxaliplatin. Secondary Determine the tolerability of this regimen, in both the short- and long-term, in these patients. Determine recurrence-free survival, overall survival, and response rate in patients treated with this regimen. Determine the quality of life of patients treated with this regimen. Determine the clinical benefits of this regimen in these patients. Determine locoregional and metastatic progression-free survival of patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Chemotherapy: Patients receive gemcitabine hydrochloride over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are restaged at day 15-21 of the fourth course of chemotherapy. Patients with nonmetastatic disease proceed to chemoradiotherapy. Chemoradiotherapy: Patients undergo radiotherapy 5 days a week for 5 weeks. Patients also receive fluorouracil IV continuously in weeks 1-5 and oxaliplatin IV over 1 hour on days 1, 8, 15, 22, and 29 in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, at restaging, and at day 28 after completion of chemoradiotherapy. After completion of study treatment, patients are followed periodically for 5 years. PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study.

Official Title
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Protocole de Phase II: Etude de Faisabilite de L'Oxaliplatine en Association Chimio-Radiotherapie Concomitante Dans le Traitement Des Cancers du Pancreas Localement Avances Non Resecables

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: fluorouracil
* Drug: gemcitabine hydrochloride
* Drug: oxaliplatin
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the pancreas Locally advanced, nonresectable disease Residual disease after surgical resection (R1, R2) OR recurrent disease after radical surgery No visceral or peritoneal metastases No adenocarcinoma of the bile ducts or the ampulla of Vater PATIENT CHARACTERISTICS: ECOG performance status 0-2 Stable or controlled pain with analgesics Not pregnant or nursing Neutrophil count ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ Creatinine ≤ 1.5 times normal OR < 3 mg/dL Creatinine clearance ≥ 40 mL/min Bilirubin ≤ 1.5 times normal Alkaline phosphatase < 5 times normal No medical condition that would preclude study treatment No active infection Negative pregnancy test No serious cardiac or respiratory disease No uncontrolled or persistent hypercalcemia No pre-existing neuropathy No biliary or gastro-duodenal obstruction No other malignancy except nonmelanomatous skin cancer, prostate cancer, or carcinoma in situ of the cervix or bladder No familial, social, geographical, or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior abdominal radiotherapy (encompassing the liver, pancreas, or spleen) At least 2 months since prior radiotherapy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fluorouracil|nan|
|Drug: gemcitabine hydrochloride|nan|
|Drug: oxaliplatin|nan|
|Radiation: radiation therapy|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability |  |  | 
| Recurrence-free survival |  |  | 
| Overall survival |  |  | 
| Response rate |  |  | 
| Quality of life |  |  | 
| Clinical benefits |  |  | 
| Locoregional and metastatic progression-free survival |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the pancreas, stage II pancreatic cancer, stage III pancreatic cancer, recurrent pancreatic cancer