Status:
TERMINATED
Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer
Lead Sponsor:
University of Southern California
Conditions:
Recurrent Breast Cancer
Metastastic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 metastat...
Eligibility Criteria
Inclusion
- 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
- \-
Key Trial Info
Start Date :
July 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT00159458
Start Date
July 1 2003
End Date
December 1 2006
Last Update
May 22 2014
Active Locations (2)
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1
Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
2
Premiere Oncology
Santa Monica, California, United States, 90404