Ro 31-7453 in Treating Patients With Locally Advanced or Metastatic Solid Tumor

• Status: Completed
• Trial end date: 2001-08-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of Ro 31-7453 in treating patients who have locally advanced or metastatic solid tumor.

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

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced and/or metastatic solid tumors for which no standard therapy is available No known CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and/or AST no greater than 2.5 times ULN (no greater than 4.0 times ULN if liver or bone metastasis present) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 4.0 times ULN if liver or bone metastasis present) Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No history of other serious medical conditions

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) Endocrine therapy: At least 4 weeks since prior hormonal therapy Concurrent antiandrogen therapy allowed Radiotherapy: At least 4 weeks since prior extended field radiotherapy Surgery: Not specified