R115777 in Treating Patients With Advanced Solid Tumors
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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 1 |
| 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:
- 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.
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
- 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
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
Additional Information:
Publications:
| 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 |
Keywords provided by City of Hope Medical Center:
|
unspecified adult solid tumor, protocol specific |
Additional relevant MeSH terms:
|
Neoplasms Tipifarnib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013