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A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer
This study is currently recruiting participants.
Verified by Emory University, November 2008
Sponsors and Collaborators: Emory University
Sanofi-Aventis
Information provided by: Emory University
ClinicalTrials.gov Identifier: NCT00674206
  Purpose

The purpose of this study is to investigate if the combination of gemcitabine and oxaliplatin is effective for triple negative breast cancer.


Condition Intervention Phase
Breast Cancer
Drug: Gemcitabine and oxaliplatin
Phase II

Genetics Home Reference related topics: breast cancer
MedlinePlus related topics: Breast Cancer Cancer
Drug Information available for: Gemcitabine hydrochloride Gemcitabine Oxaliplatin
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: A Phase II Trial of Gemcitabine and Oxaliplatin for ER-, PR-, HER2NEU- (Triple Negative) Metastatic Breast Cancer

Further study details as provided by Emory University:

Primary Outcome Measures:
  • The primary objective is to determine the Response Rate as determined by RECIST criteria in patients with triple negative advanced breast cancer treated with oxaliplatin and gemcitabine. [ Time Frame: Repeat scans will be performed every 8 weeks to assess response. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary objectives are to determine time-to-progression, overall survival, and toxicity/tolerability profile in patients with triple negative, advanced breast cancer treated with oxaliplatin and gemcitabine. [ Time Frame: Safety will be assessed throughout the clinical trial. Time-to-progression will be assessed every 4th cycle (every 8 weeks) while on study. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 51
Study Start Date: May 2008
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm Study: Experimental
All patients enrolled on clinical trial will receive gemcitabine and oxaliplatin.
Drug: Gemcitabine and oxaliplatin
Gemcitabine 1000mg/m2 on day 1 every 14 days Oxaliplatin 100mg/m2 on day 2 every 14 days Number of cycles: until progression or unacceptable toxicity develops.

Detailed Description:

In this study, participants will receive gemcitabine and oxaliplatin, drugs that have been in use for a long time. Gemcitabine is a treatment that is an effective therapy currently available to patients with this type and stage of breast cancer. Frequently, in cancer therapy, combinations of drugs prove more effective as treatment than the same drugs used alone. The combination of gemcitabine and oxaliplatin has not been tested in patients with triple negative breast cancer. It is hoped that the addition of oxaliplatin may cause your tumor to stop growing or possible your tumor may shrink. This assessment will be basd on measuring changes in the size of your tumor.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically or cytologically confirmed ER-, PR-, Her2neu- (Triple Negative) metastatic breast cancer
  • Patients must have measurable disease according to the RECIST criteria. Patients with bone metastases may be included if they have a decrease in performance status or narcotic analgesic requirement.
  • Patients must have either received a taxane in the adjuvant setting or received a taxane as first-line treatment for metastatic breast cancer
  • Age > 18 years
  • ECOG Performance Score of 0, 1, or 2 (Appendix A)
  • Adequate bone marrow as evidenced by:
  • Absolute neutrophil count > 1,500/L
  • Platelet count > 100,000/uL
  • Adequate renal function as evidenced by serum creatinine < 1.5 mg/dL
  • Adequate hepatic function as evidenced by:

    • Serum total bilirubin < 1.5 mg/dL
    • Alkaline phosphatase < 3X the ULN for the reference lab (< 5X the ULN for patients with known hepatic metastases
    • SGOT/SGPT < 3X the ULN for the reference lab (< 5X the ULN for patients with known hepatic metastases
  • Patients must be recovered from both acute and late effects of any prior surgery, radiotherapy or other antineoplastic therapy
  • Patients or their legal representatives must be able to read, understand and provide informed consent to participate in the trial.
  • Patients of childbearing potential agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method)

Exclusion Criteria:

  • Patients with an active infection or with a fever > 101.30 F within 3 days of the first scheduled day of protocol treatment
  • Patients with active CNS metastases. Patients with stable CNS disease, who have undergone radiotherapy at least 4 weeks prior to the planned first protocol treatment and who have been on a stable dose of corticosteroids for 3 weeks are eligible for the trial
  • History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current PSA of < 1.0 mg/dL on 2 successive evaluations at least 3 months apart, with the most recent evaluation within 4 weeks of entry
  • Patients with known hypersensitivity to any of the components of oxaliplatin or gemcitabine.
  • Patients who have received gemcitabine or platin-based chemotherapy in the past.
  • Patients who have received chemotherapy within 28 days of the first scheduled day of protocol treatment.
  • Patients who received radiotherapy to more than 25% of their bone marrow; or patients who received any radiotherapy within 4 weeks of entry
  • Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 28 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
  • Peripheral neuropathy Grade 2
  • Patients who are pregnant or lactating
  • Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results.
  • History of allogeneic transplant
  • Known HIV or Hepatitis B or C (active, previously treated or both)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00674206

Contacts
Contact: Amelia Zelnak 1-888-946-7447 amelia.zelnak@emoryhealthcare.org

Locations
United States, Georgia
Emory University Winship Cancer Institute Recruiting
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
Sanofi-Aventis
Investigators
Principal Investigator: Amelia Zelnak, MD Emory University Winship Cancer Institute
  More Information

Responsible Party: Winship Cancer Institute ( Amelia Zelnak, MD )
Study ID Numbers: 7792
Study First Received: May 6, 2008
Last Updated: November 17, 2008
ClinicalTrials.gov Identifier: NCT00674206  
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Metastatic breast cancer

Study placed in the following topic categories:
Oxaliplatin
Skin Diseases
Breast Neoplasms
Gemcitabine
Breast Diseases

Additional relevant MeSH terms:
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 16, 2009