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| Sponsor: | City of Hope Medical Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00025454 |
Purpose
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 |
|---|---|---|
|
Unspecified Adult Solid Tumor, Protocol Specific |
Drug: tipifarnib |
Phase I |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Phase I Trial of R115777 (NSA 702818) in Advanced Malignant Solid Tumors |
| Study Start Date: | August 2001 |
| Study Completion Date: | July 2008 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
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.
Eligibility| 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:
Contacts and Locations| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| USC/Norris Comprehensive Cancer Center and Hospital | |
| Los Angeles, California, United States, 90033-0804 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
| University of California Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| Study Chair: | Primo N. Lara, MD | University of California, Davis |
More Information
| ClinicalTrials.gov Identifier: | NCT00025454 History of Changes |
| Other Study ID Numbers: | CDR0000068963, U01CA062505, P30CA033572, CHNMC-PHI-33, NCI-4751 |
| Study First Received: | October 11, 2001 |
| Last Updated: | February 5, 2010 |
| Health Authority: | United States: Federal Government |
|
unspecified adult solid tumor, protocol specific |
|
Neoplasms Tipifarnib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |