A Phase I and Pharmacokinetic Study of Sequences of NSC 655649 (Rebeccamycin Analogue) and Cisplatin Without and With Granulocyte Colony-Stimulating Factor Support Every 21 Days

Fecha de inicio: 1 de octubre de 1999

DISEASE CHARACTERISTICS: Histologically or cytologically proven advanced malignancy that is refractory to prior therapy or unlikely to benefit from standard therapy (e.g., chemotherapy, radiotherapy, and surgery) Part I: Previously untreated OR minimally pretreated Ineligible for part I and considered heavily pretreated if: Prior radiotherapy to wide ports involving the pelvis or at least 25% of bone marrow Greater than 6 courses of prior combination chemotherapy including alkylating agent Prior nitrosoureas or mitomycin Widespread bone metastases with bone marrow involvement by bone marrow biopsy (positive bilateral bone marrow biopsy for lymphoma patients) Part II: Heavily pretreated as defined above Measurable or evaluable disease PATIENT CHARACTERISTICS: Age: 18 and over Performance status: SWOG 0-2 Life expectancy: At least 3 months Hematopoietic: Absolute neutrophil count greater than 1,500/mm^3 Hemoglobin greater than 9 mg/dL Platelet count greater than 100,000/mm^3 Hepatic: Bilirubin less than 1.5 mg/dL Renal: Creatinine less than 1.5 mg/dL Cardiovascular: No uncontrolled hypertension No angina pectoris No clinically significant, multifocal, uncontrolled cardiac dysrhythmias Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No active serious infection No clinically severe peripheral neuropathy (grade 1 or worse) No nonmalignant medical condition that would preclude compliance or increase risk of participation in study No hypersensitivity to E. coli derived drug preparations PRIOR CONCURRENT THERAPY: Biologic therapy: No other concurrent colony stimulating factors for prophylactic purposes Chemotherapy: At least 3 weeks since prior chemotherapy (6 weeks since prior nitrosoureas and mitomycin) and recovered Endocrine therapy: No chronic oral corticosteroids No concurrent corticosteroids except as prophylactic antiemetic Radiotherapy: At least 3 weeks since prior radiotherapy and recovered Other: At least 1 month since prior investigational agent No prophylactic oral or IV antibiotics for neutropenia unless fever present No other concurrent anticancer treatment or investigational agent