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

This study has been terminated.
(Insufficient Accrual)
Sponsor:
Information provided by:
USC/Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00159458
First received: September 8, 2005
Last updated: April 18, 2007
Last verified: August 2006
History of Changes
  Purpose

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.


Condition Intervention Phase
Recurrent Breast Cancer
Metastastic Breast Cancer
 Drug: Gemcitabine and oxaliplatin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by USC/Norris Comprehensive Cancer Center:

Study Start Date: July 2003
Study Completion Date: December 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Exclusion Criteria:

-

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00159458

Locations
United States, California
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Premiere Oncology
Santa Monica, California, United States, 90404
Sponsors and Collaborators
USC/Norris Comprehensive Cancer Center
Investigators
Principal Investigator: Christy Russell, MD LAC/USC Medical Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00159458     History of Changes
Other Study ID Numbers: 1B-03-1
Study First Received: September 8, 2005
Last Updated: April 18, 2007
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on May 23, 2013