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

Phase 3

Completed

• Conditions: Pancreatic Cancer

• Registration Number: NCT00032175
• Lead Sponsor: Cancer Research UK

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2002-03-08
• Study Start: 2002-04
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Status Verified: 2007-04
• Study Completion: 2007-05
• Last Update Submitted: 2013-06-25
• Last Update Posted: 2013-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 508

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival at 1 year

Secondary Outcome Measures

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

Trial Locations

Locations (30)

Royal United Hospital; 🇬🇧 Bath, England, United Kingdom

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, England, United Kingdom

Bristol Haematology and Oncology Centre; 🇬🇧 Bristol, England, United Kingdom

Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust; 🇬🇧 Cambridge, England, United Kingdom

Derbyshire Royal Infirmary; 🇬🇧 Derby, England, United Kingdom

Royal Devon and Exeter Hospital; 🇬🇧 Exeter, England, United Kingdom

Ipswich Hospital NHS Trust; 🇬🇧 Ipswich, England, United Kingdom

Queen Elizabeth Hospital; 🇬🇧 King's Lynn, England, United Kingdom

Cookridge Hospital at Leeds Teaching Hospital NHS Trust; 🇬🇧 Leeds, England, United Kingdom

Leicester Royal Infirmary; 🇬🇧 Leicester, England, United Kingdom

Scroll for more (20 remaining)