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

University of Southern California

Status and phase: Terminated; Phase 2

Conditions: Metastastic Breast Cancer; Recurrent Breast Cancer

Treatments: Drug: Gemcitabine and oxaliplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00159458

1B-03-1

Details and patient eligibility

About

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.

Enrollment: 7 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)