Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer

Study Overview
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Brief Summary
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RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if gemcitabine is more effective with or without capecitabine in treating pancreatic cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of gemcitabine with or without capecitabine in treating patients who have advanced pancreatic cancer.

Detailed Description
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OBJECTIVES: Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine. Compare the clinical benefit response, objective tumor response, duration of response, and time to progression in patients treated with these regimens. Compare the toxicity of these regimens in these patients. Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to metastases (yes vs no), pain (yes vs no), Karnofsky performance status (60-80% vs 90-100%), and participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Patients initially receive gemcitabine IV over 30 minutes weekly for 7 weeks. After 1 week of rest, patients receive gemcitabine IV over 30 minutes weekly for 3 weeks. Treatment then repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, weekly for weeks 2-7, and then before each gemcitabine administration. Patients are followed every 9 weeks. PROJECTED ACCRUAL: A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

Official Title
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Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Drug: Gemcitabine + Capecitabine
* Drug: Gemcitabine alone


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma No CNS metastases PATIENT CHARACTERISTICS: Age: Over 18 Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 10.0 g/dL Hepatic: Bilirubin no greater than 5 times normal AST/ALT no greater than 5 times normal Alkaline phosphatase no greater than 5 times normal Renal: Creatinine clearance at least 30 mL/min Gastrointestinal: No grade 2 or greater nausea or grade 1 or greater vomiting No medical condition that would interfere with taking oral medications or with gastrointestinal absorption (e.g., small bowel obstruction) Other: No prior unanticipated severe reaction to fluoropyrimidine therapy No known hypersensitivity to fluorouracil No known dihydropyrimidine dehydrogenase deficiency No active infection No other serious concurrent systemic disorders that would preclude study participation No other malignancy within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior capecitabine No prior chemotherapy for advanced pancreatic cancer At least 1 year since prior radiochemotherapy for pancreatic cancer Endocrine therapy: Not specified Radiotherapy: See Chemotherapy At least 1 year since prior adjuvant radiotherapy for pancreatic cancer No concurrent radiotherapy Surgery: Prior Whipple procedure or duodenal bypass allowed Other: At least 1 month since prior investigational agents No concurrent sorivudine or its chemically related analogues (e.g., brivudine) No other concurrent anticancer or investigational drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Gemcitabine + Capecitabine<br>Gemcitabine + Capecitabine | Drug: Gemcitabine + Capecitabine<br>* Gemcitabine + Capecitabine<br>|
| Active Comparator: Gemcitabine alone<br>Gemcitabine alone | Drug: Gemcitabine alone<br>* Gemcitabine alone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gemcitabine + Capecitabine vs. Gemcitabine alone | To compare survival, efficacy, quality of life and toxicity between the combination therapy (Capecitabine and Gemcitabine) and the monotherapy (Gemcitabine alone) in advanced pancreatic cancer. | 8 weeks | 

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