Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)

NCT ID: NCT00006199

Last Updated: 2005-06-24

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this clinical trial is to establish the safest doses for the combination of a farnesyl transferase inhibitor, R115777 plus topotecan in patients with advanced solid tumors, previously treated or beyond standard therapy of clinical benefit. Maximum tolerated dose, dose limiting toxicity and the activity of this combination will be assessed.

This chemotherapy regimen is a two-pronged attack at the way cancer cells replicate. R115777 is a compound that may inhibit cancer cell growth by interfering with the p21 ras oncogene, while topotecan, a topoisomerase-1 inhibitor, works on cancer cells not subject to control by the ras oncogene. Animal studies suggest that the combination may be synergistic. Another advantage is that R115777 can be taken by mouth.

Detailed Description

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Conditions

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Cancer

Keywords

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solid tumor

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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R115777 (farnesyl transferase inhibitor)

Intervention Type DRUG

Topotecan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with advanced solid tumors with previous treatment or beyond standard therapy of significant clinical benefit
* Therapy with no more than 3 prior chemotherapy regimens
* Radiotherapy to less than 25% of bone marrow volume (no pelvic radiation)
* Adequate organ function
* Recovery from the effects of prior chemotherapy and radiation therapy, with at least a 4 week interval. All prior toxicities should have resolved to baseline prior to entry into the study.
* Good performance status
* Anticipate life expectancy of at least 6 months
* Not pregnant or lactating.
* Sexually active men and women of childbearing age must use adequate contraception.
* Be able to give signed, written informed consent.
* No gastrointestinal condition that could affect the absorption of the drug
* No active infection requiring systemic medical therapy one week prior to chemotherapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Locations

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NYU Cancer Institute

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Anita Tierney

Role: CONTACT

Phone: 1-212-263-2173

Facility Contacts

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Anita Tierney

Role: primary

Other Identifiers

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M01RR000096

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCRR-M01RR00096-1001

Identifier Type: -

Identifier Source: org_study_id