Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Over 18 Other SWS-SAKK-44/00 CECOG/PAN-1.3.001, EU-20142, NCT00030732

Objectives

1. Compare the overall survival of patients with advanced pancreatic cancer treated with gemcitabine with or without capecitabine.
2. Compare the clinical benefit response, objective tumor response, duration of response, and time to progression in patients treated with these regimens.
3. Compare the toxicity of these regimens in these patients.
4. Compare the quality of life of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

• Histologically or cytologically confirmed primary inoperable or metastatic pancreatic adenocarcinoma



• No CNS metastases

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

Patient Characteristics:

Age:

• Over 18

Performance status:

• Karnofsky 60-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 3,500/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 300 patients (150 per treatment arm) will be accrued for this study within 3 years.

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.

Bernhard J, Dietrich D, Scheithauer W, et al.: Clinical benefit and quality of life in patients with advanced pancreatic cancer receiving gemcitabine plus capecitabine versus gemcitabine alone: a randomized multicenter phase III clinical trial--SAKK 44/00-CECOG/PAN.1.3.001. J Clin Oncol 26 (22): 3695-701, 2008.[PUBMED Abstract]

Hess V, Glimelius B, Grawe P, et al.: CA 19-9 tumour-marker response to chemotherapy in patients with advanced pancreatic cancer enrolled in a randomised controlled trial. Lancet Oncol 9 (2): 132-8, 2008.[PUBMED Abstract]

Herrmann R, Bodoky G, Ruhstaller T, et al.: Gemcitabine plus capecitabine compared with gemcitabine alone in advanced pancreatic cancer: a randomized, multicenter, phase III trial of the Swiss Group for Clinical Cancer Research and the Central European Cooperative Oncology Group. J Clin Oncol 25 (16): 2212-7, 2007.[PUBMED Abstract]

Herrmann R, Bodoky G, Ruhstaller T, et al.: Gemcitabine (G) plus capecitabine (C) versus G alone in locally advanced or metastatic pancreatic cancer. A randomized phase III study of the Swiss Group for Clinical Cancer Research (SAKK) and the Central European Cooperative Oncology Group (CECOG). [Abstract] J Clin Oncol 23 (Suppl 16): A-LBA4010, 310s, 2005.

Trial Contact Information

Trial Lead Organizations

Swiss Group for Clinical Cancer Research

Richard Herrmann, MD, Protocol chair		Ph: 41-61-265-5075 Email: rherrmann@uhbs.ch

Central European Cooperative Oncology Group

Werner Scheithauer, MD, Protocol chair		Ph: 43-1-404-005-462

Registry Information
Official Title		Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial
Trial Start Date		2001-06-15
Registered in ClinicalTrials.gov		NCT00030732
Date Submitted to PDQ		2001-12-21
Information Last Verified		2008-08-12

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