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

This study has been terminated.

( Insufficient Accrual )

First Received: September 8, 2005 Last Updated: April 18, 2007 History of Changes

Sponsored by:	Norris Comprehensive Cancer Center
Information provided by:	Norris Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00159458

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Oxaliplatin Gemcitabine Gemcitabine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer

Further study details as provided by 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

Norris Comprehensive Cancer Center

Investigators

Principal Investigator:

Christy Russell, MD

LAC/USC Medical Center

More Information

No publications provided

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

Study placed in the following topic categories:

Antimetabolites
Oxaliplatin
Radiation-Sensitizing Agents
Immunologic Factors
Skin Diseases
Breast Neoplasms

Gemcitabine
Immunosuppressive Agents
Antiviral Agents
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Disease Attributes
Antimetabolites, Antineoplastic
Immunologic Factors
Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Breast Neoplasms
Enzyme Inhibitors
Immunosuppressive Agents

Antiviral Agents
Pharmacologic Actions
Recurrence
Neoplasms
Oxaliplatin
Neoplasms by Site
Pathologic Processes
Radiation-Sensitizing Agents
Therapeutic Uses
Gemcitabine
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009