Tipifarnib and Gemcitabine Hydrochloride in Treating Women With Metastatic Breast Cancer

NCT00100750 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2015-01-13

No results posted yet for this study

Summary

This phase I/II trial is studying the side effects and best dose of tipifarnib when given together with gemcitabine hydrochloride and to see how well they work in treating women with breast cancer that has spread to other parts of the body. Tipifarnib is a drug that binds to specific proteins on the tumor cells and then kills these cells. Gemcitabine hydrochloride is a chemotherapy drug that may kill tumor cells by preventing cells from dividing. Giving tipifarnib together with gemcitabine hydrochloride may kill more tumor cells.

Conditions

  • Recurrent Breast Carcinoma
  • Stage IV Breast Cancer

Interventions

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Tipifarnib

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Banu Arun · M.D. Anderson Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2007-10-31
Completion
2010-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00100750 on ClinicalTrials.gov