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

Primary Purpose

Extrahepatic Bile Duct Cancer, Gallbladder Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
capecitabine
gemcitabine hydrochloride
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extrahepatic Bile Duct Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 10, 2004
Last Updated
January 11, 2012
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00084942
Brief Title
Gemcitabine and Capecitabine in Treating Patients With Advanced and/or Inoperable Cholangiocarcinoma or Carcinoma of the Gallbladder
Official Title
A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
October 2002 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extrahepatic Bile Duct Cancer, Gallbladder Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
capecitabine
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milind Javle, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Gibbs, MD
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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