R115777 in Treating Patients With Advanced Solid Tumors
- Conditions
- Unspecified Adult Solid Tumor, Protocol Specific
- Registration Number
- NCT00025454
- Lead Sponsor
- City of Hope Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
City of Hope Comprehensive Cancer Center
🇺🇸Duarte, California, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
City of Hope Medical Group
🇺🇸Pasadena, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
City of Hope Comprehensive Cancer Center🇺🇸Duarte, California, United States