Phase I Trial of Escalating Doses of BNP7787 in Patients With Solid Tumors Undergoing Treatment With Cisplatin and Taxol

Fecha de inicio: 1 de marzo de 1998

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung cancer, ovarian carcinoma, squamous cell carcinoma of the head and neck, tumor types for which no standard treatment exists, or tumor types that have failed standard therapy Paclitaxel and cisplatin combination therapy must be an appropriate option in treating disease No potentially curable type of cancer (e.g., newly diagnosed testicular cancer) PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 weeks Hematopoietic: WBC greater than 4,000/mm^3 Absolute neutrophil count greater than 1,500/mm^3 Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin normal SGOT and SGPT normal Renal: Creatinine normal Creatinine clearance at least 60 mL/min Cardiovascular: No evidence of congestive heart failure No uncontrolled moderate to severe hypertension Includes patients with persistent elevated systolic blood pressures of greater than 170 mm Hg and diastolic blood pressures of greater than 100 mm Hg for more than 1 month while under medical treatment Other: No active infection No perceived or actual clinical risk of cisplatin induced toxicity that exceeds the clinical benefit of using cisplatin therapy No known history of severe hypersensitivity to polyoxyl 35 castor oil vehicle No severe medical problems unrelated to malignancy that would interfere with compliance in this study Not pregnant Effective contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent colony stimulating factors except for febrile neutropenia No concurrent aminoglycoside therapy except for febrile neutropenia or other life threatening infections No concurrent immunotherapy Chemotherapy: At least 6 weeks since prior nitrosoureas or mitomycin At least 3 weeks since other prior chemotherapy No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to measurable disease Surgery: At least 2 weeks since prior major surgery Other: No other concurrent investigational agents