NCT00006199

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 9, 2000

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 11, 2000

Completed
Last Updated

June 24, 2005

Status Verified

January 1, 2004

First QC Date

September 9, 2000

Last Update Submit

June 23, 2005

Conditions

Cancer

Keywords

solid tumor

Interventions

R115777 (farnesyl transferase inhibitor)DRUG
TopotecanDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NYU Cancer Institute

New York, New York, 10016, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

tipifarnibTopotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Central Study Contacts

Anita Tierney

CONTACT

1-212-263-2173

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

September 9, 2000

First Posted

September 11, 2000

Last Updated

June 24, 2005

Record last verified: 2004-01

Locations

US(1)