Status:
COMPLETED
Alvocidib, Oxaliplatin, Fluorouracil, and Leucovorin Calcium in Treating Patients With Advanced Solid Tumors
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This phase I trial is studying the side effects and best dose of alvocidib when given together with oxaliplatin, fluorouracil, and leucovorin calcium in treating patients with advanced solid tumors. D...
Detailed Description
OBJECTIVES: I. Determine the maximum tolerated dose of flavopiridol when given in combination with oxaliplatin, fluorouracil, and leucovorin calcium in patients with advanced solid tumors. II. Deter...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Histologically confirmed advanced solid tumor
- Refractory to standard therapy or no standard therapy exists
- Evaluable disease
- No known untreated CNS metastases
- Patients who have undergone local treatment for brain metastases and whose brain metastases are stable by repeat imaging study performed ≤ 4 weeks after treatment are allowed
- No primary CNS tumors
- Performance status - Karnofsky 60-100%
- WBC ≥ 3,500/mm\^3
- Neutrophil count ≥ 1,500/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin ≤ 1.5 mg/dL
- AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN for liver metastases)
- Creatinine ≤ 1.5 mg/dL
- No cardiac arrhythmias within the past 6 months
- No congestive heart failure within the past 6 months
- No myocardial infarction within the past 6 months
- No arterial or venous thrombosis within the past year
- No peripheral neuropathy \> grade 1
- No other medical condition that would preclude study participation
- No serious or uncontrolled infection
- HIV negative
- Not pregnant or nursing
- No nursing during and for 2 months after study participation
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 2 months after study participation
- At least 2 weeks since prior immunotherapy
- At least 2 weeks since prior chemotherapy (6 weeks for nitrosoureas and mitomycin)
- No prior flavopiridol
- At least 2 weeks since prior radiotherapy
- Recovered from all prior therapy
- No concurrent therapy for thrombosis
- Prophylaxis for central lines or deep vein thrombosis allowed
- No other concurrent investigational medications
- No concurrent vitamins, antioxidants, or herbal preparations and supplements
- Concurrent single-tablet multivitamin allowed
Exclusion
Key Trial Info
Start Date :
February 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00080990
Start Date
February 1 2004
Last Update
December 16 2013
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065