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

Cancer Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00006199
• Other study ID #: NCRR-M01RR00096-1001
• Secondary ID: M01RR000096
• Status: Recruiting
• Phase: Phase 1
• First received: September 9, 2000
• Last updated: June 23, 2005

Study information

• Verified date: January 2004
• Source: National Center for Research Resources (NCRR)
• Contact: Anita Tierney
• Phone: 1-212-263-2173
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• R115777 (farnesyl transferase inhibitor)

• Topotecan

Locations

Country	Name	City	State
United States	NYU Cancer Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Research Resources (NCRR)

Country where clinical trial is conducted

United States,