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

This study is currently recruiting participants.

Verified by National Center for Research Resources (NCRR), January 2004

First Received: September 9, 2000 Last Updated: June 23, 2005 History of Changes

Sponsor:	National Center for Research Resources (NCRR)
Information provided by:	National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:	NCT00006199

Purpose

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.

Condition	Intervention	Phase
Cancer	Drug: R115777 (farnesyl transferase inhibitor) Drug: Topotecan	Phase I

Study Type:	Interventional
Study Design:	Treatment

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Topotecan hydrochloride Topotecan R 115777 Tipifarnib

U.S. FDA Resources

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006199

Contacts

Contact: Anita Tierney

1-212-263-2173

Locations

United States, New York
NYU Cancer Institute	Recruiting
New York, New York, United States, 10016
Contact: Anita Tierney 212-263-2173

Sponsors and Collaborators

National Center for Research Resources (NCRR)

More Information

No publications provided

Study ID Numbers:	NCRR-M01RR00096-1001, M01RR00096
Study First Received:	September 9, 2000
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00006199 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Center for Research Resources (NCRR):

solid tumor

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Enzyme Inhibitors

Topotecan
Pharmacologic Actions
Tipifarnib

ClinicalTrials.gov processed this record on November 05, 2009