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

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Treatment	Completed	Over 18	Other	CRUK-GEM-CAP EU-20116, ISRCTN11513444, NCT00032175

Objectives

1. Compare the 1-year survival rate of patients with locally advanced or metastatic pancreatic cancer treated with gemcitabine with or without capecitabine.
2. Compare the median and 2-year survival rates and the objective response rates of 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 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

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)

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

Expected Enrollment

A total of 508 patients (254 per treatment arm) will be accrued for this study.

Outcomes

Survival at 1 year

Quality of life
Median survival rate
Survival rate at 2 years
Toxicity
Objective response rate

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

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Liverpool Cancer Trials Unit

Emily Owen, Study coordinator		Ph: 44-151-794-8932

Registry Information
Official Title		A Phase III Multicenter Randomized Clinical Trial Comparing Gemcitabine Alone Or In Combination With Capecitabine For The Treatment Of Patients With Advanced Pancreatic Cancer
Trial Start Date		2002-04-09
Registered in ClinicalTrials.gov		NCT00032175
Date Submitted to PDQ		2002-01-23
Information Last Verified		2007-04-05

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