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

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ClinicalTrials.gov Identifier: NCT00006199
Recruitment Status : Unknown
Verified January 2004 by National Center for Research Resources (NCRR).
Recruitment status was:  Recruiting
First Posted : September 11, 2000
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
National Center for Research Resources (NCRR)

Brief 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.


Condition or disease Intervention/treatment Phase
Cancer Drug: R115777 (farnesyl transferase inhibitor) Drug: Topotecan Phase 1

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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)

ClinicalTrials.gov Identifier: NCT00006199     History of Changes
Other Study ID Numbers: NCRR-M01RR00096-1001
M01RR000096 ( U.S. NIH Grant/Contract )
First Posted: September 11, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: January 2004

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

Additional relevant MeSH terms:
Topotecan
Tipifarnib
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents