Ro 31-7453 in Treating Patients With Metastatic Solid Tumors

• Status: Completed
• Trial end date: 2001-10-01
• 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: Randomized phase I trial to determine if Ro 31-7453 is more effective with or without food in treating patients who have metastatic solid tumors.

• 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 or metastatic solid tumor for which no standard therapy is available No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 3,000/mm3 Absolute neutrophil 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) AST and ALT no greater than 1.5 times ULN (4 times ULN for liver metastases) Alkaline phosphatase no greater than 2.5 times ULN (4 times ULN for liver or bone metastases) Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No history or clinical signs of significant cardiovascular disease Other: No other serious concurrent illness No greater than grade II neuropathy No evidence of gastrointestinal dysfunction No intolerance to a high-fat meal Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 3 weeks since prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) Endocrine therapy: At least 2 weeks since prior endocrine therapy (except for antiandrogen therapy) Concurrent antiandrogen therapy allowed Concurrent corticosteroids allowed if stable dose for at least 2 weeks prior to study Radiotherapy: At least 3 weeks since prior radiotherapy Surgery: Not specified Other: No prior enrollment in this study At least 4 weeks since prior investigational drugs No other concurrent investigational agents