BMS-214662 Plus Trastuzumab in Treating Patients With Advanced Solid Tumors

Completed · Phase 1

Conditions studied: Unspecified Adult Solid Tumor, Protocol Specific

In brief

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

Key facts

Study ID: NCT00022529
Run by: National Cancer Institute (NCI)
People needed: 28
Starts: 2001-07-01
Last updated by the study team: 2013-01-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

Where it is running

Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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