Gemcitabine With or Without Capecitabine in Treating Patients With Locally Advanced or Metastatic 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 compare the effectiveness of gemcitabine with or without capecitabine in treating patients who have locally advanced or metastatic pancreatic cancer.

Detailed Description
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OBJECTIVES: Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine. Compare the median and 2-year survival rates and the objective response rates of 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 an randomized, open-label, multicenter study. Patients are stratified according to disease stage (locally advanced vs metastatic) and performance status (0 and 1 vs 2). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15 and oral capecitabine twice daily on days 1-21. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive gemcitabine IV over 30 minutes on days 1, 8, 15, 22, 29, 36, and 43 during the first course. After a 1-week rest period, patients receive gemcitabine IV over 30 minutes on days 1, 8, and 15. Subsequent courses repeat every 28 days for 4 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 3 months for 1 year, and then annually thereafter. Patients are followed every 3 months. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 508 patients (254 per treatment arm) will be accrued for this study.

Official Title
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A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer

Conditions
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Pancreatic Cancer

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


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically or cytologically confirmed ductal adenocarcinoma of the pancreas Locally advanced or metastatic disease not amenable to curative surgical resection Macroscopic residual disease after prior resection with histological confirmation is allowed Unidimensionally measurable disease No intracerebral metastases or meningeal carcinomatosis PATIENT CHARACTERISTICS: Age: Over 18 Performance status: WHO 0-2 Life expectancy: More than 3 months Hematopoietic: WBC greater than 3,000/mm3 Neutrophil count greater than 1,500/mm3 Platelet count greater than 100,000/mm3 Hepatic: Bilirubin less than 2 mg/dL Renal: Creatinine less than 2 mg/dL Creatinine clearance greater than 50 mL/min Cardiovascular: No New York Heart Association class III or IV heart disease No uncontrolled angina pectoris Other: No other prior malignancy except nonmelanoma skin cancer or carcinoma in situ of the cervix No other concurrent uncontrolled medical condition No other medical or psychiatric condition that would preclude study No known hypersensitivity to fluorouracil No dihydropyrimidine dehydrogenase deficiency No known malabsorption syndromes Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy (including preoperative or adjuvant) for this disease No other concurrent cytotoxic chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy (including preoperative or adjuvant) for this disease Surgery: See Disease Characteristics Other: No prior investigational drugs (including preoperative or adjuvant) for this disease No other concurrent investigational drugs No concurrent dipyridamole or allopurinol No concurrent sorivudine or sorivudine analogs (e.g., brivudine) (capecitabine arm only)

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
Allocation: Randomized
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival at 1 year |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life |  |  | 
| Median survival rate |  |  | 
| Survival rate at 2 years |  |  | 
| Toxicity |  |  | 
| Objective response rate |  |  | 

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