Status:
COMPLETED
Imatinib Mesylate and Capecitabine in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
Herbert Hurwitz
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
RATIONALE: Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as cape...
Detailed Description
OBJECTIVES: Primary * Determine the maximum tolerated dose and recommended phase II dose of imatinib mesylate when administered with capecitabine in patients with advanced malignant solid tumors. S...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed malignant solid tumors for which no standard effective therapy exists OR such therapy is refused
- Previously treated brain metastases that are currently asymptomatic allowed
- PATIENT CHARACTERISTICS:
- Performance status
- Karnofsky 70-100%
- Life expectancy
- Not specified
- Hematopoietic
- Absolute neutrophil count \> 2,000/mm\^3
- Platelet count \> 100,000 mm\^3
- Hemoglobin \> 9.0 g/dL
- Hepatic
- Alkaline phosphatase \< 2.5 times upper limit of normal (ULN)
- SGOT and SGPT \< 2.5 times ULN
- Bilirubin \< 1.5 times ULN
- Renal
- Creatinine clearance \> 50 mL/min
- Cardiovascular
- No congestive heart failure
- No symptomatic coronary artery disease
- No uncontrolled cardiac arrhythmias
- No myocardial infarction within the past 12 months
- No other clinically significant cardiac disease
- Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after completion of study treatment
- No prior unanticipated severe reaction to fluoropyrimidine therapy
- No known sensitivity to fluorouracil
- PRIOR CONCURRENT THERAPY:
- Biologic therapy
- More than 28 days since prior biologic therapy
- Chemotherapy
- More than 28 days since prior chemotherapy (42 days for nitrosoureas or mitomycin C)
- Endocrine therapy
- At least 90 days since prior steroids for the treatment of brain metastases
- More than 28 days since prior hormonal therapy
- Radiotherapy
- At least 90 days since prior radiotherapy for the treatment of brain metastases
- More than 28 days since other prior radiotherapy
- No prior pelvic radiotherapy \> 30% of the bone marrow
- Surgery
- More than 28 days since prior surgery and recovered
Exclusion
Key Trial Info
Start Date :
August 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00253565
Start Date
August 1 2003
End Date
July 1 2010
Last Update
April 8 2013
Active Locations (1)
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1
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710