Alvocidib, Oxaliplatin, Fluorouracil, and Leucovorin Calcium in Treating Patients With Advanced Solid Tumors

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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. Drugs used in chemotherapy, such as alvocidib, oxaliplatin, fluorouracil, and leucovorin calcium, work in different ways to stop tumor cells from dividing so they stop growing or die. Alvocidib may also make tumor cells more sensitive to chemotherapy. Combining more than one chemotherapy drug may kill more tumor cells.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Alvocidib; Calcium; Calcium, Dietary; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin

Criteria

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