Status:
COMPLETED
Irinotecan, Oxaliplatin, and Capecitabine in Treating Patients With Unresectable Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
Drugs used in chemotherapy, such as irinotecan, oxaliplatin, and capecitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherap...
Detailed Description
OBJECTIVES: I. To define the maximally tolerated dose of the combination of CPT-11 (irinotecan hydrochloride), oxaliplatin, and capecitabine in three different populations, based on UDP glucuronosylt...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed solid tumor for which there is no known standard therapy that is potentially curative or capable of extending life expectancy
- Unresectable disease
- Willing to provide biologic specimens to determine UGT1A1 genotype
- No CNS metastases
- Prior CNS metastases allowed provided patient was treated with surgery and/or radiotherapy and is stable for more than 8 weeks
- Performance status - ECOG 0-2
- At least 12 weeks
- Absolute neutrophil count at least 1,500/mm\^3
- Platelet count at least 100,000/mm\^3
- Hemoglobin at least 9.0 g/dL
- Bilirubin no greater than upper limit of normal (ULN) for patients with 6/6 UGT1A1 genotype (1.5 times ULN for patients with 6/7 \[closed to accrual as of 8/24/06\] or 7/7 UGT1A1 genotype)
- AST no greater than 3 times ULN (5 times ULN if there is liver involvement)
- Creatinine no greater than 1.5 times ULN
- No New York Heart Association class III or IV heart disease
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No prior allergy to platinum compounds, irinotecan, or to antiemetics or antidiarrheals appropriate for administration with study therapy
- No uncontrolled infection
- No seizure disorder
- No peripheral neuropathy grade 2 or greater
- More than 4 weeks since prior biologic therapy
- More than 4 weeks since prior immunotherapy
- No concurrent immunotherapy
- No concurrent prophylactic colony-stimulating factor therapy
- More than 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
- No other concurrent chemotherapy
- See Disease Characteristics
- More than 4 weeks since prior radiotherapy
- No prior radiotherapy to more than 25% of the bone marrow
- No concurrent radiotherapy
- See Disease Characteristics
- No other concurrent investigational therapy
- No concurrent sorivudine, brivudine, lamivudine, or stavudine
- No concurrent enrollment in any other study involving a pharmacologic agent for symptom control or therapeutic intent
Exclusion
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
84 Patients enrolled
Trial Details
Trial ID
NCT00074321
Start Date
November 1 2003
Last Update
June 6 2013
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905