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

Primary Purpose

Recurrent Breast Cancer, Metastastic Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine and oxaliplatin
Sponsored by
University of Southern California
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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: -

Sites / Locations

  • Norris Comprehensive Cancer Center
  • Premiere Oncology

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 8, 2005
Last Updated
May 20, 2014
Sponsor
University of Southern California
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1. Study Identification

Unique Protocol Identification Number
NCT00159458
Brief Title
Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer
Official Title
Phase II Clinical Trial of Gemcitabine and Oxaliplatin in Recurrent or Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Why Stopped
Insufficient Accrual
Study Start Date
July 2003 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Breast Cancer, Metastastic Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Gemcitabine and oxaliplatin

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christy Russell, MD
Organizational Affiliation
LAC+USC Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Premiere Oncology
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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