R115777 in Treating Patients With Advanced Solid Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors

Conditions
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Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Drug: tipifarnib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tipifarnib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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unspecified adult solid tumor, protocol specific