Breast Cancer Clinical Trial

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

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.

View Eligibility Criteria

Eligibility 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:

-

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT00159458

Recruitment Status:

Terminated

Sponsor:

University of Southern California

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 2 Locations for this study

See Locations Near You

Norris Comprehensive Cancer Center
Los Angeles California, 90033, United States
Premiere Oncology
Santa Monica California, 90404, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

7

Study ID:

NCT00159458

Recruitment Status:

Terminated

Sponsor:


University of Southern California

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider