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


Phase 2
18 Years
N/A
Not Enrolling
Female
Recurrent Breast Cancer, Metastastic Breast Cancer

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Trial Information

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


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:

-

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Christy Russell, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

LAC/USC Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

1B-03-1

NCT ID:

NCT00159458

Start Date:

July 2003

Completion Date:

December 2006

Related Keywords:

  • Recurrent Breast Cancer
  • Metastastic Breast Cancer
  • Breast Neoplasms

Name

Location

Premiere OncologySanta Monica, California  90404
Norris Comprehensive Cancer CenterLos Angeles, California  90033