NCT00084942CompletedPhase 2
A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Locations
- 2
Study Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine with capecitabine in treating patients who have advanced and/or inoperable cholangiocarcinoma or carcinoma (cancer) of the gallbladder.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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:
- •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
- •Bilirubin < 3 mg/dL
- •Creatinine ≤ 1.6 mg/dL
- •Cardiovascular
- •No symptomatic congestive heart failure
- •No unstable angina pectoris
- •No cardiac arrhythmia
- •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
- •Not specified
- •No other concurrent investigational agents
- •No other concurrent anticancer agents or therapies
Exclusion Criteria
- Not provided
Investigators
Study Sites (2)
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