Capecitabine And Gemcitabine In Patients With Advanced Or Metastatic Biliary Tract Cancer, A Multicenter Phase II Trial
capecitabine plus gemcitabine
Adenocarcinoma+14
+ Bile Duct Diseases
+ Bile Duct Neoplasms
Supportive Care Study
Summary
Study start date: April 1, 2003
Actual date on which the first participant was enrolled.OBJECTIVES: Primary * Determine the ability of palliative capecitabine and gemcitabine to maintain or improve tumor-related symptoms (after treatable biliary duct obstruction has been relieved) as measured by the clinical benefit response in patients with locally advanced or metastatic biliary tract cancer. Secondary * Determine the clinical benefit response in patients treated with this regimen. * Determine the time to and duration of clinical benefit response in patients treated with this regimen. * Determine the objective response and time to progression in patients treated with this regimen. * Determine the overall survival of patients treated with this regimen. * Determine the quality of life of patients treated with this regimen. * Determine the adverse events in patients treated with this regimen. OUTLINE: This is an open-label, multicenter study. Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and oral capecitabine twice daily on days 1-14 (28 total doses). Treatment repeats every 21 days for 8 courses in the absence of disease progression or unacceptable toxicity. Patients responding to treatment may receive additional courses at the discretion of the investigator. Quality of life is assessed at baseline, weekly during weeks 2-9 (courses 1-3), and then before each administration of gemcitabine. Patients are followed every 3 months for 1 year and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 19-44 patients will be accrued for this study within 3 years.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.44 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Supportive Care 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.From 18 to 80 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 biliary tract cancer * Locally advanced, unresectable, or metastatic disease * Metastatic adenocarcinoma with clinical documentation of gallbladder or bile tree involvement with no evidence of another primary adenocarcinoma allowed * Measurable or nonmeasurable disease * Treatable biliary duct obstruction must be relieved by either internal endoscopic drainage/stenting or palliative bypass surgery before study entry * Symptomatic biliary tract cancer and has at least 1 of the following: * Karnofsky 60-80% * Baseline analgesic consumption at least 10 mg of morphine equivalents per day * Baseline pain intensity score of at least 20 mm out of a possible 100 mm * No prior or concurrent CNS metastasis PATIENT CHARACTERISTICS: Age * 18 to 80 Performance status * See Disease Characteristics * Karnofsky 60-100% Life expectancy * Not specified Hematopoietic * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10.0 g/dL Hepatic * Bilirubin no greater than 4 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * AST and ALT no greater than 5 times ULN Renal * Creatinine clearance greater than 50 mL/min Cardiovascular * No uncontrolled cardiovascular disease Gastrointestinal * Able to ingest oral medication * No malabsorption syndrome * No intractable nausea and/or vomiting * No partial small bowel obstruction Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 1 year after study participation * No active autoimmune disease * No uncontrolled diabetes * No known hypersensitivity to fluorouracil * No known dihydropyrimidine dehydrogenase deficiency * No definitive contraindication to corticosteroids * No prior significant neurologic or psychiatric disorders (e.g., psychotic disorders, dementia, or seizures) that would preclude understanding or providing informed consent * No prior severe reaction to fluoropyrimidine therapy * No psychiatric disorder, cognitive dysfunction, or language problem that would preclude filling out the quality of life questionnaire or patient diary * No other serious underlying medical condition that would preclude study participation * No other malignancy within the past 5 years except nonmelanoma skin cancer or adequately treated carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy * No prior biologic therapy * No prior immunotherapy Chemotherapy * No prior chemotherapy for advanced/metastatic disease * No prior palliative chemotherapy Endocrine therapy * No concurrent megestrol Radiotherapy * More than 4 weeks since prior radiotherapy * No concurrent radiotherapy * Treatment of a single painful lesion allowed Surgery * See Disease Characteristics * Prior Whipple procedure allowed * Prior duodenal bypass allowed * No concurrent endoscopic or external biliary drainage as a consequence of progressive malignant bile duct obstruction * Drainage as a consequence of nonmalignant bile duct obstruction allowed Other * More than 30 days since prior treatment within a clinical study * No other concurrent anticancer drugs * No other concurrent investigational drugs * No concurrent sorivudine or its chemically-related analogues (e.g., lamivudine)
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
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