R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors
NCT ID: NCT00005990
Last Updated: 2012-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
INTERVENTIONAL
2000-08-31
Brief Summary
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PURPOSE: Phase I trial to study the effectiveness of R115777 plus topotecan in treating patients who have advanced solid tumors.
Detailed Description
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* Determine the dose-limiting toxic effects of R115777 and topotecan in patients with advanced solid tumors.
* Determine the maximum tolerated dose of this regimen in these patients.
* Determine pharmacokinetic profiles of topotecan alone and in combination with R115777 in these patients.
* Measure the inhibition of ras-farnesylation and topo-1 inhibition in peripheral blood mononuclear cells in these patients when treated with this regimen.
* Determine activity of this treatment in these patients.
OUTLINE: This is a dose-escalation, multicenter study.
Patients receive oral R115777 twice daily on days 2-21 (in the first course only R115777 begins on day 3) and topotecan IV continuously on days 1-21. Treatment continues every 28 days in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of R115777 and topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 3 or 6 patients experience dose-limiting toxicity.
PROJECTED ACCRUAL: A total of 18-24 patients will be accrued for this study.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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tipifarnib
topotecan hydrochloride
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed advanced solid tumor not amenable to standard curative therapy
PATIENT CHARACTERISTICS:
Age:
* 18 and over
Performance status:
* ECOG 0-1
Life expectancy:
* At least 6 months
Hematopoietic:
* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic:
* Bilirubin no greater than 1.5 mg/dL
* SGOT no greater than 5 times upper limit of normal (ULN)
* Alkaline phosphatase no greater than 5 times ULN
* No significant hepatic dysfunction that would preclude study
Renal:
* Creatinine no greater than 1.5 mg/dL OR
* Creatinine clearance at least 50 mL/min
Cardiovascular:
* No significant cardiovascular dysfunction that would preclude study
Other:
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No malabsorption syndrome, partial or complete bowel obstruction, disease significantly affecting gastrointestinal function, or major resection of the stomach or proximal small bowel
* At least 1 week since prior active infection requiring systemic medical therapy
* No significant organ system dysfunction (neurologic, endocrine) that would preclude study
* No dementia or altered mental status that would preclude study
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* Not specified
Chemotherapy:
* No more than 3 prior chemotherapy regimens
* At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy:
* Not specified
Radiotherapy:
* No more than 25% of bone marrow volume irradiated
* No prior pelvic radiation
* At least 4 weeks since prior radiotherapy and recovered
Surgery:
* Not specified
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Howard S. Hochster, MD
Role: STUDY_CHAIR
NYU Langone Health
Locations
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NYU Cancer Institute at New York University Medical Center
New York, New York, United States
Countries
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Other Identifiers
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NYU-9932
Identifier Type: -
Identifier Source: secondary_id
NCI-T99-0110
Identifier Type: -
Identifier Source: secondary_id
CDR0000067979
Identifier Type: -
Identifier Source: org_study_id