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

This study has been terminated.
(Insufficient Accrual)
Sponsor:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT00159458
First received: September 8, 2005
Last updated: April 18, 2007
Last verified: August 2006

September 8, 2005
April 18, 2007
July 2003
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Complete list of historical versions of study NCT00159458 on ClinicalTrials.gov Archive Site
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Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer
Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer

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.

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Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Recurrent Breast Cancer
  • Metastastic Breast Cancer
Drug: Gemcitabine and oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
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December 2006
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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:

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Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00159458
1B-03-1
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University of Southern California
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Principal Investigator: Christy Russell, MD LAC/USC Medical Center
University of Southern California
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP