Trials / Completed
CompletedNCT00084942
Gemcitabine and Capecitabine in Treating Patients With Advanced and/or Inoperable Cholangiocarcinoma or Carcinoma of the Gallbladder
A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Roswell Park Cancer Institute · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | capecitabine | |
| DRUG | gemcitabine hydrochloride |
Timeline
- Start date
- 2002-10-01
- Primary completion
- 2004-05-01
- Completion
- 2006-11-01
- First posted
- 2004-06-11
- Last updated
- 2012-01-12
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00084942. Inclusion in this directory is not an endorsement.