Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
Gemcitabine Plus Capecitabine Versus Gemcitabine Alone In Advanced Pancreatic Cancer. A Randomized Phase III Trial
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed primary inoperable or metastatic pancreatic
adenocarcinoma
- No CNS metastases
PATIENT CHARACTERISTICS:
Age:
- Over 18
Performance status:
- Karnofsky 60-100%
Life expectancy:
- Not specified
Hematopoietic:
- WBC at least 3,500/mm^3
- Platelet count at least 100,000/mm^3
- 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
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Gemcitabine + Capecitabine vs. Gemcitabine alone
Outcome Description:
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.
Outcome Time Frame:
8 weeks
Safety Issue:
No
Principal Investigator
Richard Herrmann, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Universitaetsspital-Basel
Authority:
Switzerland: Swissmedic
Study ID:
SAKK 44/00
NCT ID:
NCT00030732
Start Date:
June 2001
Completion Date:
April 2008
Related Keywords:
- Pancreatic Cancer
- stage III pancreatic cancer
- recurrent pancreatic cancer
- adenocarcinoma of the pancreas
- stage IV pancreatic cancer
- Pancreatic Neoplasms
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