A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
Data Collection
Adenocarcinoma+12
+ Bile Duct Diseases
+ Bile Duct Neoplasms
Treatment Study
Summary
Study start date: October 1, 2002
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the response rate in patients with advanced and/or inoperable cholangiocarcinoma or carcinoma of the gallbladder treated with gemcitabine and capecitabine. Secondary * Determine time to disease progression and overall survival of patients treated with this regimen. * Determine quality of life of patients treated with this regimen. OUTLINE: This is an open-label study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at weeks 3, 6, 9, and 12. Patients are followed monthly. PROJECTED ACCRUAL: A total of 9-17 patients will be accrued for this study within 1.5 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed cholangiocarcinoma or carcinoma of the gallbladder * Advanced and/or inoperable disease * Measurable disease * At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan * No known brain metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy * More than 2 months Hematopoietic * WBC ≥ 3,000/mm\^3 * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 Hepatic * Bilirubin \< 3 mg/dL Renal * Creatinine ≤ 1.6 mg/dL Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs * No ongoing or active infection * No psychiatric illness or social situation that would preclude study compliance * No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * More than 4 weeks since prior chemotherapy and recovered * No more than 1 prior chemoembolization OR chemoradiotherapy regimen for locally advanced biliary tract cancer * No other prior chemotherapy (except adjuvant therapy) Endocrine therapy * Not specified Radiotherapy * See Chemotherapy * More than 4 weeks since prior radiotherapy and recovered Surgery * Not specified Other * No other concurrent investigational agents * No other concurrent anticancer agents or therapies
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location