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

NCT00894504 | Completed Phase 2 Results

• 1 other identifier: SCRI BRE 126
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 17

Brief Summary

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.

Conditions

Metastatic Breast Cancer

Keywords

Metastatic Breast Cancer; Triple Negative; Panitumumab; Vectibix; Gemcitabine; Gemzar; Carboplatin

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival (PFS)

  Measured from Day 1 of study drug administration to disease progression - defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as a 20% increase in the sum of the longest diameter of target lesions and/or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions

  every 6 weeks until treatment discontinuation

Secondary Outcomes (3)

• Objective Response Rate and Clinical Benefit Rate

  every 6 weeks until treatment discontinuation

• Number of Treatment-related Toxicities Occurring in ≥10% of Patients as a Measure of Tolerability and Toxicity

  every 6 weeks until discontinuation of treatment, expected average of 18 months

• Correlation of Biomarker Expressions of EGFR, K-ras, p53, PTEN Expression, and PI3K in Triple-negative Breast Cancer With Response to Treatment With the Combination of Gemcitabine, Carboplatin, and Panitumumab

  18 months

Study Arms (1)

Panitumumab/Gemcitabine/Carboplatin

EXPERIMENTAL

Systemic therapy

Drug: Panitumumab; Drug: Carboplatin; Drug: Gemcitabine

Interventions

Panitumumab DRUG

6 mg/kg IV on Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)

Also known as: Systemic Therapy, Vectibix

Panitumumab/Gemcitabine/Carboplatin

Carboplatin DRUG

AUC=2.5 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)

Also known as: Systemic Therapy, Paraplatin

Panitumumab/Gemcitabine/Carboplatin

Gemcitabine DRUG

1500 mg/m2 IV, Day 1 of each 2-week treatment cycle for 3 cycles (6 weeks)

Also known as: Systemic Therapy, Gemzar

Panitumumab/Gemcitabine/Carboplatin

Eligibility Criteria

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

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).

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.

Sponsors & Collaborators

• SCRI Development Innovations, LLC: lead
• Amgen: collaborator
• Eli Lilly and Company: collaborator

Study Sites (17)

Los Robles

Thousand Oaks, California, 91360, United States

Location

Aventura Hospital and Medical Center

Aventura, Florida, 33180, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, United States

Location

Providence Medical Group

Terre Haute, Indiana, 47802, United States

Location

Norton Cancer Institute

Louisville, Kentucky, 40207, United States

Location

Center for Cancer and Blood Disorders

Bethesda, Maryland, 20817, United States

Location

National Capital Clinical Research Consortium

Bethesda, Maryland, 20817, United States

Location

St. Louis Cancer Care

Chesterfield, Missouri, 63017, United States

Location

Research Medical Center

Kansas City, Missouri, 64132, United States

Location

Nebraska Methodist Cancer Center

Omaha, Nebraska, 68114, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Oncology Hematology Care

Cincinnati, Ohio, 45242, United States

Location

Chattanooga Oncology Hematology Associates

Chattanooga, Tennessee, 37404, United States

Location

Family Cancer Center

Collierville, Tennessee, 38119, United States

Location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Texas Health Physician Group

Dallas, Texas, 76011, United States

Location

Peninsula Cancer Institute

Newport News, Virginia, 23601, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Panitumumab; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: John D. Hainsworth, MD
• Organization: Sarah Cannon Research Institute

asksarah@scresearch.net

1-877-691-7274

Study Officials

• Denise A Yardley, M.D.

  SCRI Development Innovations, LLC

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2009
• First Posted: May 7, 2009
• Study Start: February 1, 2010
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: May 15, 2015
• Results First Posted: December 15, 2014

Record last verified: 2015-04

Locations

US (17)