Gemcitabine and Capecitabine in Treating Patients With Advanced and/or Inoperable Cholangiocarcinoma or Carcinoma of the Gallbladder

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma

Conditions
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Extrahepatic Bile Duct Cancer, Gallbladder Cancer

Intervention / Treatment
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* Drug: capecitabine
* Drug: gemcitabine hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: capecitabine|nan|
|Drug: gemcitabine hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cholangiocarcinoma of the gallbladder, recurrent gallbladder cancer, unresectable gallbladder cancer, cholangiocarcinoma of the extrahepatic bile duct, recurrent extrahepatic bile duct cancer, unresectable extrahepatic bile duct cancer