BMS-214662 in Treating Patients With Solid Tumors

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

Summary

Phase I trial to study the effectiveness of BMS-214662 in treating patients who have solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

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

Details

• Lead Sponsor: National Cancer Institute (NCI)

Criteria

Inclusion Criteria:

• Diagnosis of malignant solid tumor for which a standard curative therapy does not exist

• Performance status - Karnofsky 70-100%

• At least 6 months

• WBC at least 3,000/mm^3

• Absolute neutrophil count at least 1,500/mm^3

• Platelet count at least 100,000/mm^3

• Hemoglobin at least 10.0 g/dL

• Bilirubin no greater than 2.0 mg/dL

• AST no greater than 2 times upper limit of normal

• Albumin at least 3.0 g/dL

• Creatinine no greater than 1.5 mg/dL

• No uncontrolled heart disease

• No history of clinically significant cardiac arrhythmia that could be exacerbated by QT interval prolongation

• Corrected QT interval no greater than 450 milliseconds

• Must not require total parenteral nutrition

• No manifestations of malabsorption syndrome due to prior surgery, gastrointestinal disease, or unknown reasons

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• No signs or symptoms of acute infection requiring systemic therapy

• No grade 3 or 4 neurotoxicity from prior anticancer treatment or neuropathy from any cause

• No confusion, disorientation, or psychiatric illness that may preclude study

• No more than 3 prior chemotherapy regimens

• At least 4 weeks since prior chemotherapy (6 weeks since prior nitrosoureas or mitomycin) and recovered

• No other concurrent antineoplastic agents

• No concurrent hormonal anticancer therapy

• At least 4 weeks since prior radiotherapy

• No concurrent radiotherapy

• Prior drugs known to prolong the QT interval allowed if they can be safely discontinued for a time period equal to 4 elimination half-lives prior to administering study drug

• No drugs known to prolong the QT interval during and for 24 hours after study drug

• No concurrent therapy with known CYP3A4 substrates

• No other concurrent investigational agents