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Sponsors and Collaborators: |
Beckman Research Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00025454 |
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.
Condition | Intervention | Phase |
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Unspecified Adult Solid Tumor, Protocol Specific |
Drug: tipifarnib |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors |
Study Start Date: | August 2001 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed malignant tumors deemed to be incurable or refractory to therapy
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, California | |
City of Hope Comprehensive Cancer Center | |
Duarte, California, United States, 91010-3000 | |
City of Hope Medical Group | |
Pasadena, California, United States, 91105 | |
University of California Davis Cancer Center | |
Sacramento, California, United States, 95817 | |
USC/Norris Comprehensive Cancer Center and Hospital | |
Los Angeles, California, United States, 90033-0804 |
Study Chair: | Primo N. Lara, MD | University of California, Davis |
Study ID Numbers: | CDR0000068963, CHNMC-PHI-33, NCI-4751 |
Study First Received: | October 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00025454 History of Changes |
Health Authority: | United States: Federal Government |
unspecified adult solid tumor, protocol specific |
Tipifarnib |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tipifarnib |