Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma. PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.

Detailed Description
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OBJECTIVES: Primary Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin. Secondary Compare the time of response in patients treated with these regimens. Compare the clinical benefit of and tolerance to these regimens in these patients. Compare the quality of life of patients treated with these regimens. Compare the progression-free survival of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity. After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy. Quality of life is assessed at baseline and then every 2 months. PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.

Official Title
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Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: gemcitabine hydrochloride
* Drug: oxaliplatin


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed pancreatic adenocarcinoma Locally advanced or metastatic disease Unresectable disease Measurable disease At least 2 cm by a classical scanner and at least 1 cm by a spiral scanner No adenocarcinoma of the bile ducts or ampulla of Vater No known brain metastases PATIENT CHARACTERISTICS: Age 18 to 75 Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 12 weeks Hematopoietic Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic Bilirubin less than 1.5 times normal Alkaline phosphatase less than 5 times normal Renal Creatinine less than 1.5 times normal No uncontrolled or persistent hypercalcemia Cardiovascular No serious cardiac failure Pulmonary No serious respiratory failure Other Pain must be stabilized or controlled before initiation of study treatment Not pregnant or nursing Fertile patients must use effective contraception No other untreatable malignant tumor No serious psychological, familial, social, or geographical condition that would preclude study participation No neuropathy that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy Endocrine therapy No concurrent corticosteroids except for antiemetic therapy Radiotherapy No prior radiotherapy Surgery Not specified

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gemcitabine hydrochloride|nan|
|Drug: oxaliplatin|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to response |  |  | 
| Clinical benefit |  |  | 
| Quality of life |  |  | 
| 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, stage IV pancreatic cancer