Status:
COMPLETED
Safety Study of a New Schedule of Capecitabine and Docetaxel to Treat Cancers
Lead Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborating Sponsors:
Hoffmann-La Roche
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The combination of capecitabine and docetaxel is given to treat several different types of cancer. Capecitabine is usually given by mouth for 14 days, and docetaxel is given IV on the first day of cap...
Detailed Description
This is a phase I study using an accelerated titration design to determine the maximum tolerated dose (MTD) of capecitabine given orally on a BID schedule from days 1-14, in combination with docetaxel...
Eligibility Criteria
Inclusion
- Patients with a histologically or cytologically proven metastatic solid tumor.
- Patients with measurable disease or an evaluable bone lesion that will not undergo biopsy.
- Patients treated within the additional cohort at MTD will have metastatic breast cancer with a site of disease that is amenable to percutaneous FNA and must be willing to undergo serial FNA biopsies of their primary tumor.
- Age \> 18 years.
- Life expectancy of at least 6 months.
- ECOG performance status 0-2.
- Adequate hematologic, hepatic, and renal function
- Patients must have an intact upper gastrointestinal tract, be able to swallow tablets, and not have a malabsorption syndrome.
Exclusion
- No significant uncontrolled infectious or cardiovascular disease, or a myocardial infarction within the prior 12 months.
- No prior organ allograft.
- No prior treatment with capecitabine or with docetaxel.
- No prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
- No concurrent antacid therapy is allowed.
- No other significant medical/surgical diseases.
Key Trial Info
Start Date :
January 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2006
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00169000
Start Date
January 1 2003
End Date
March 1 2006
Last Update
August 6 2009
Active Locations (1)
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1
Norris Cotton Cancer Center
Lebanon, New Hampshire, United States, 03756