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Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)
This study is currently recruiting participants.
Study NCT00006199   Information provided by National Center for Research Resources (NCRR)
First Received: September 9, 2000   Last Updated: June 23, 2005   History of Changes

September 9, 2000
June 23, 2005
 
 
 
 
Complete list of historical versions of study NCT00006199 on ClinicalTrials.gov Archive Site
 
 
 
Study of the Farnesyl Transferase Inhibitor, R115777, in Combination With Topotecan (NYU 99-32)
 

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.

 
Phase I
Interventional
Treatment
Cancer
  • Drug: R115777 (farnesyl transferase inhibitor)
  • Drug: Topotecan
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
 
 
 

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
Both
18 Years and older
No
Contact: Anita Tierney 1-212-263-2173
United States
 
NCT00006199
 
NCRR-M01RR00096-1001, M01RR00096
National Center for Research Resources (NCRR)
 
 
National Center for Research Resources (NCRR)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP