BMS-214662 Plus Trastuzumab in Treating Patients With Advanced 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 plus trastuzumab in treating patients who have advanced solid tumors. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Trastuzumab

Criteria

Inclusion Criteria:

• Histologically or cytologically confirmed solid tumor that is unresponsive to currently available therapies or for which no known effective therapy exists

• Overexpressing HER-2-neu (2+ or 3+) by immunohistochemistry or fluorescent in situ hybridization

• Clinically or radiologically evaluable disease

• No carcinomatous meningitis or untreated/uncontrolled metastatic brain parenchymal disease

• At least 8 weeks since prior therapy for prior brain parenchymal disease and asymptomatic off corticosteroids

• Performance status - ECOG 0-2

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

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

• Bilirubin no greater than 1.8 mg/dL

• ALT and AST no greater than 1.5 times upper limit of normal (ULN)

• Creatinine no greater than 1.5 times ULN

• No uncontrolled or significant cardiovascular disease

• No myocardial infarction within the past 6 months

• No prior clinically significant atrial or ventricular arrhythmias

• No prior second or third degree heart block

• No ischemic heart disease requiring medication

• No congestive heart failure

• Corrected QT interval no greater than 450 milliseconds by electrocardiogram

• Ejection fraction at least lower limit of normal by MUGA scan

• No uncontrolled or significant pulmonary disease

• No active unresolved infection

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 3 months after study

• At least 4 weeks since prior immunotherapy, including trastuzumab (Herceptin), and recovered

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

• No anthracyclines for at least 22 weeks after completion of study therapy

• No other concurrent chemotherapy

• Concurrent hormone replacement therapy allowed

• No other concurrent hormonal therapy

• At least 4 weeks since prior radiotherapy and recovered

• No prior radiotherapy to more than 25% of the bone marrow-containing skeleton

• No concurrent radiotherapy

• At least 4 weeks since prior investigational agents and recovered

• At least 7 days since prior known substrates of cytochrome P450-3A4 (CYP3A4)

• At least 7 days since prior parenteral antibiotics

• No concurrent substrates of CYP3A4

• No concurrent parenteral antibiotics

• No other concurrent experimental medications