Gemcitabine With or Without Capecitabine in Treating Patients With Advanced Pancreatic Cancer
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|ClinicalTrials.gov Identifier: NCT00030732|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 15, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Drug: Gemcitabine + Capecitabine Drug: Gemcitabine alone||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||319 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial|
|Study Start Date :||June 2001|
|Actual Primary Completion Date :||June 2004|
|Actual Study Completion Date :||April 2008|
Active Comparator: Gemcitabine + Capecitabine
Gemcitabine + Capecitabine
Drug: Gemcitabine + Capecitabine
Gemcitabine + Capecitabine
Active Comparator: Gemcitabine alone
Drug: Gemcitabine alone
- Gemcitabine + Capecitabine vs. Gemcitabine alone [ Time Frame: 8 weeks ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00030732
|Study Chair:||Richard Herrmann, MD||Universitaetsspital-Basel|
|Study Chair:||Werner Scheithauer, MD||Allgemeines Krankenhaus - Universitatskliniken|