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

NCT ID: NCT00159458

Last Updated: 2014-05-22

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-07-31
• Study Completion Date: 2006-12-31

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.

Conditions

Recurrent Breast Cancer; Metastastic Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Gemcitabine and oxaliplatin

Intervention Type: DRUG

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)
• Peripheral neuropathy grade 0-1

Exclusion Criteria

• Prior tx with gemcitabine or oxaliplatin. Prior tx with cisplatin or carboplatin allowed if completed >12 mos prior to enrollment.
• Underlying medical, psychiatric, or social conditions that would preclude patient from receiving tx
• Peripheral neuropathy greater than or equal to Gr 2

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christy Russell, MD

Role: PRINCIPAL_INVESTIGATOR

LAC+USC Medical Center

Locations

Norris Comprehensive Cancer Center

Los Angeles, California, United States

Premiere Oncology

Santa Monica, California, United States

Countries

United States

Other Identifiers

1B-03-1

Identifier Type: -

Identifier Source: org_study_id