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A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Gemcitabine
Oxaliplatin
Sponsored by
Emory University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Metastatic breast cancer

Eligibility Criteria

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

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/microL
  • 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 (Upper limit for normal) for patients with known hepatic metastases
    • SGOT/SGPT < 3X the ULN(Upper limit for normal) 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)

Sites / Locations

  • Emory University Winship Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemcitabine and Oxaliplatin

Arm Description

All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.

Outcomes

Primary Outcome Measures

Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.
A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.

Secondary Outcome Measures

Overall Survival From Time of Study Entry
The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived. Note: Not all patients started the study at the same time so the time frame is different from the full range. The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived.

Full Information

First Posted
May 6, 2008
Last Updated
November 18, 2013
Sponsor
Emory University
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00674206
Brief Title
A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer
Official Title
A Phase II Trial of Gemcitabine and Oxaliplatin for ER-, PR-, HER2NEU- (Triple Negative) Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Terminated
Why Stopped
Sponsor funding stopped
Study Start Date
October 2008 (undefined)
Primary Completion Date
August 2009 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Metastatic 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
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gemcitabine and Oxaliplatin
Arm Type
Experimental
Arm Description
All patients enrolled on clinical trial will receive Gemcitabine 1000mg/m^2 on Day 1 and Oxaliplatin 100 mg/m^2 intravenously over 2 hours on Day 2.
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemcitabine, Oxaliplatin
Intervention Description
Gemcitabine 1000mg/m^2 on day 1 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal
Intervention Type
Drug
Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin 100mg/m^2 on day 2 every 14 days Cycles of treatment will be repeated every 2 weeks until disease progression, intolerable toxicity, or the development of any of the criteria for study removal
Primary Outcome Measure Information:
Title
Number of Participants With Complete Response, Partial Response, Progressive Disease and Stable Disease.
Description
A sum of the longest diameter(LD) for all target lesions will be calculated and reported as the baseline sum LD. Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD):At least a 20% increase in the sum of the LD of target lesions. Stable Disease (SD):Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Overall Survival From Time of Study Entry
Description
The number of weeks patient survived from the time of patient entry. The time frame reflects the time the first patient was entered into the study to the time till the last patient survived. Note: Not all patients started the study at the same time so the time frame is different from the full range. The full range reflects the least number of weeks a patient survived to the most number of weeks a patient survived.
Time Frame
132 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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/microL 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 (Upper limit for normal) for patients with known hepatic metastases SGOT/SGPT < 3X the ULN(Upper limit for normal) 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amelia Zelnak, MD
Organizational Affiliation
Emory University Winship Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase II Trial of Gemcitabine and Oxaliplatin for Triple Negative Metastatic Breast Cancer

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