Expired Study
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New York, New York 10016


RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of R115777 plus topotecan in treating patients who have advanced solid tumors.

Study summary:

OBJECTIVES: - 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.


DISEASE CHARACTERISTICS: - 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

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

R115777 Plus Topotecan in Treating Patients With Advanced Solid Tumors

Official Title:

Phase I and Pharmacokinetic Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan

Overall Status:


Study Phase:

Phase 1



Minimum Age:

18 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

New York University School of Medicine

Oversight Authority:

United States: Food and Drug Administration

Reasons Why Stopped:

Study Type:


Study Design:

Primary Purpose: Treatment

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:

Overall Contact Information

Official Name:Howard S. Hochster, MD
Study Chair
New York University School of Medicine

Study Dates

Start Date:August 2000
Primary Completion Date:September 2006
Primary Completion Type:Actual
Verification Date:January 2006
Last Changed Date:November 8, 2012
First Received Date:July 5, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Intervention Type:Drug
Name:topotecan hydrochloride

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:New York University School of Medicine
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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