Panitumumab, Gemcitabine and Carboplatin in Triple-Negative Metastatic Breast Cancer

Completed · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

In this Phase II trial, the investigators will evaluate the combination of gemcitabine, carboplatin, and panitumumab in the treatment of patients with metastatic triple-negative breast cancer. In addition, to assess the efficacy of this combination, tumor tissue will be examined for the presence of various markers, including K-ras and PI3K-activating mutations, EGFR, PTEN, and p53. Correlation of tumor response with marker expression may define a patient subset that is particularly responsive to treatment with a panitumumab-containing combination.

Key facts

Study ID

NCT00894504

Run by

SCRI Development Innovations, LLC

People needed

71

Starts

2010-02-01

Expected to finish

2014-09-01

Last updated by the study team

2015-05-15

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female patients >=18 years of age.
• Histologically or cytologically confirmed diagnosis of unresectable locally advanced or stage IV breast cancer.
• No more than 1 prior treatment regimen for metastatic breast cancer.
• Estrogen receptor and progesterone receptor negative (defined as <10% staining by IHC).
• Paraffin-embedded tumor tissue (from the primary tumor or metastasis) for biomarker testing. (In the absence of paraffinembedded tissue, unstained paraffin-embedded tumor slides are acceptable).
• Measurable disease, as defined by the Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) guidelines
• HER2 negative tumors. HER2 negativity must be confirmed by one of the following:
• FISH-negative (FISH ratio <2.2), or
• IHC 0-1+, or
• IHC 2-3+ AND FISH-negative (FISH ratio <2.2)
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-1.
• Absolute neutrophil count (ANC) >=1.5 × 109/L; platelet count >=100 × 109/L; hemoglobin >=9.0 g/dL.
• Creatinine <=1.5 mg/dL, or creatinine clearance >=40 mL/min (as calculated by the Cockcroft-Gault method, as follows: Female creatinine clearance = (140 - age) × (weight in kg) × 0.85 (serum creatinine × 72)
• Adequate hepatic function, defined as follows: total bilirubin <=1.5 x ULN; aspartate aminotransferase (AST) <=3 × ULN (or <= 5 x ULN if liver metastases); alanine aminotransferase (ALT) <=3 x ULN (or <=5 x ULN if liver metastases).
• Magnesium level >= the institutional lower limit of normal (LLN).
• Women of childbearing potential must agree to use adequate contraception (per institutional standard of care) during treatment and until 6 months after the last administration of investigational products.

You may not qualify if…

• Patients with brain metastases are not eligible.
• History of another primary cancer, with the exception of the following:
• Curatively treated in situ cervical cancer;
• Curatively resected non-melanoma skin cancer;
• Other primary solid tumor curatively treated with no known active disease present and no treatment administered for >=5 years prior to study enrollment.
• History of interstitial lung disease (e.g., pneumonitis, pulmonary fibrosis), or any evidence of interstitial lung disease on the CT scan of the chest performed at the baseline visit.
• Prior anti-EGFR antibody therapy (e.g., cetuximab), or treatment with small-molecule EGFR inhibitors (e.g., gefitinib, erlotinib, lapatinib).
• Radiotherapy <=14 days prior to study enrollment. Any acute effects of radiotherapy must be resolved prior to the administration of study drugs.
• Systemic chemotherapy, hormonal therapy, immunotherapy, or experimental or approved proteins/antibodies (e.g., bevacizumab) <=21 days prior to study enrollment.
• Prior therapy with gemcitabine or carboplatin in the metastatic setting is not permitted. Patients who received gemcitabine or carboplatin as part of adjuvant therapy are eligible, as long as recurrence was first documented >12 months after the last exposure to the drug(s).
• Major surgery within 28 days or minor surgery within 14 days of study enrollment.
• Requirement of chronic use of immunosuppressive agents (e.g., methotrexate, cyclosporine).
• Any investigational agent or therapy <=30 days prior to study enrollment.
• Uncontrolled or intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia.
• History of any medical or psychiatric condition or laboratory abnormality that, in the opinion of the investigator, may increase the risks associated with the study participation or administration of the investigational products, or that may interfere with the interpretation of the results.
• Unwillingness or inability to comply with study requirements.
• Women who are pregnant or breastfeeding.
• Patients with known human immunodeficiency virus (HIV), hepatitis C virus, and/or acute or chronic hepatitis B virus infection.

Where it is running

• Los Robles — Thousand Oaks, California, United States
• Aventura Hospital and Medical Center — Aventura, Florida, United States
• Florida Cancer Specialists — Fort Myers, Florida, United States
• Providence Medical Group — Terre Haute, Indiana, United States
• Norton Cancer Institute — Louisville, Kentucky, United States
• Center for Cancer and Blood Disorders — Bethesda, Maryland, United States
• National Capital Clinical Research Consortium — Bethesda, Maryland, United States
• St. Louis Cancer Care — Chesterfield, Missouri, United States
• Research Medical Center — Kansas City, Missouri, United States
• Nebraska Methodist Cancer Center — Omaha, Nebraska, United States
• Atlantic Health System — Morristown, New Jersey, United States
• Oncology Hematology Care — Cincinnati, Ohio, United States
• Chattanooga Oncology Hematology Associates — Chattanooga, Tennessee, United States
• Family Cancer Center — Collierville, Tennessee, United States
• Tennessee Oncology — Nashville, Tennessee, United States
• Texas Health Physician Group — Dallas, Texas, United States
• Peninsula Cancer Institute — Newport News, Virginia, United States

Full record on ClinicalTrials.gov

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