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

NCT00159458 | Terminated Phase 2

• 1 other identifier: 1B-03-1
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 2

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

Interventions

Gemcitabine and oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (2)

Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

Premiere Oncology

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Study Officials

• Christy Russell, MD

  LAC+USC Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: July 1, 2003
• Primary Completion: November 1, 2006
• Study Completion: December 1, 2006
• Last Updated: May 22, 2014

Record last verified: 2014-05

Locations

US (2)