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

Recurrent Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00159458
• Other study ID #: 1B-03-1
• Status: Terminated
• Phase: Phase 2
• First received: September 8, 2005
• Last updated: May 20, 2014
• Start date: July 2003
• Est. completion date: December 2006

Study information

• Verified date: May 2014
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: December 2006
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastastic Breast Cancer
• Recurrent Breast Cancer

Intervention

Drug:
• Gemcitabine and oxaliplatin

Locations

Country	Name	City	State
United States	Norris Comprehensive Cancer Center	Los Angeles	California
United States	Premiere Oncology	Santa Monica	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States,