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

NCT00674206 | Terminated Phase 2 Results DMC

• 2 other identifiers: IRB000077927792
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Cancer

Keywords

Metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  8 weeks

Secondary Outcomes (1)

• Overall Survival From Time of Study Entry

  132 weeks

Study Arms (1)

Gemcitabine and Oxaliplatin

EXPERIMENTAL

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.

Drug: Gemcitabine; Drug: Oxaliplatin

Interventions

Gemcitabine DRUG

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

Also known as: Gemcitabine, Oxaliplatin

Gemcitabine and Oxaliplatin

Oxaliplatin DRUG

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

Gemcitabine and Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Emory University: lead
• Sanofi: collaborator

Study Sites (1)

Emory University Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Gemcitabine; gemcitabine-oxaliplatin regimen; Oxaliplatin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Coordination Complexes; Organic Chemicals

Limitations and Caveats

Early termination of the study due to slow accrual

Results Point of Contact

• Title: Dr. Amelia Zelnak
• Organization: Emory University

amelia.zelnak@emoryhealthcare.org

404-778-1900

Study Officials

• Amelia Zelnak, MD

  Emory University Winship Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 6, 2008
• First Posted: May 7, 2008
• Study Start: October 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: October 1, 2009
• Last Updated: December 12, 2013
• Results First Posted: July 26, 2012

Record last verified: 2013-11

Locations

US (1)