Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer

University of Southern California2 sites in 1 country7 target enrollmentJuly 2003

ConditionsRecurrent Breast Cancer Metastastic Breast Cancer

DrugsGemcitabine and oxaliplatin

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Recurrent Breast Cancer
Sponsor: University of Southern California
Enrollment: 7
Locations: 2
Status: Terminated
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to find out if the combination of gemcitabine and oxaliplatin chemotherapy will be effective in reducing or eliminating the tumor(s) in patients with recurrent or metastatic breast cancer.

Gemcitabine is a chemotherapy drug approved by the U.S. Food and Drug Administration (FDA) for the treatment of pancreatic and lung cancer; oxaliplatin is a chemotherapy drug that is approved by the FDA for the treatment of colon cancer. Neither gemcitabine nor oxaliplatin are approved for the treatment of breast cancer. However, both drugs have been shown to decrease the size of breast cancer tumors.

Registry

clinicaltrials.gov

Start Date

July 2003

End Date

December 2006

Last Updated

11 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Southern California

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Histologically proven dx of recurrent or metastatic breast cancer
•Must have received at least 1 but not more than 3 prior chemotherapy regimens for recurrent or metastatic breast cancer. Patients who relapse within 12 months of completing adjuvant chemotherapy can only have had up to 2 prior regimens for metastatic disease. Patients who relapse within 12 months of completing adjuvant chemotherapy containing an anthracycline and a taxane, do not require prior chemotherapy for metastatic disease.
•Unidimensionally measurable dz (by RECIST)
•At least 18 yrs of age
•SWOG PS 0-2
•AGC greater than or equal to 1.5; platelets greater than or equal to 100,000; Hgb greater than or equal to 8.0
•Total bilirubin less than or equal to 2 x uln; SGOT and/or SGPT and alk phos up to 2.5 x uln
•Creatinine less than or equal to 2.0
•Fully recovered from acute toxicities secondary to prior tx
•Signed informed consent (including HIPAA authorization)