Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
unspecified adult solid tumor, protocol specific
Brief 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 R115777 in treating patients who have advanced solid tumors.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of R115777 in patients with advanced malignant solid tumors. * Assess the toxicity of this drug in these patients. * Determine, preliminarily, the efficacy of this drug in these patients. * Determine the potential predictors of response in patients treated with drug. OUTLINE: This is a multicenter, dose-escalation study. Patients receive oral R115777 twice daily on weeks 1 and 3. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of R115777 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. PROJECTED ACCRUAL: A minimum of 20 patients will be accrued for this study within 12 months.
Interventions
DRUGtipifarnib
Sponsors
National Cancer Institute (NCI)
City of Hope Medical Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically confirmed malignant tumors deemed to be incurable or refractory to therapy * Advanced, recurrent, or metastatic disease * Previously treated with at least 1 chemotherapy regimen * Brain metastases allowed if asymptomatic and controlled (e.g., after prior surgical resection or radiotherapy/radiosurgery) and not on steroids or anticonvulsants PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Karnofsky 60-100% Life expectancy: * Not specified Hematopoietic: * WBC at least 3,500/mm3 * Absolute granulocyte count at least 1,500/mm3 * Platelet count at least 75,000/mm3 Hepatic: * Bilirubin no greater than 2.5 times upper limit of normal (ULN) * SGOT no greater than 2.5 times ULN Renal: * Creatinine clearance at least 60 mL/min OR * Creatinine no greater than 1.6 mg/dL Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after study PRIOR CONCURRENT THERAPY: Biologic therapy: * No concurrent biologic therapy Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosourea) Endocrine therapy: * See Disease Characteristics * No concurrent hormonal therapy Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * No prior radiotherapy to a field containing a measurable target lesion unless there is evidence of progression or a new lesion is present * No concurrent radiotherapy to measurable lesions Surgery: * See Disease Characteristics * At least 3 weeks since prior major surgery and recovered Other: * At least 2 weeks since prior proton pump inhibitors (e.g., omeprazole) * Concurrent H2 blockers (e.g., cimetidine or related drugs) or antacids are allowed if there is an interval of at least 2 hours between H2 blocker/antacid intake and R115777 dosing
Countries
United States
Outcome results
None listed