A Phase II Clinical Trial of Weekly Paclitaxel and Carboplatin in Combination With Panitumumab in Metastatic Breast Cancer Patients With Triple Negative Disease
Overview
- Phase
- Phase 2
- Intervention
- panitumumab
- Conditions
- Breast Cancer
- Sponsor
- Wake Forest University Health Sciences
- Enrollment
- 14
- Locations
- 2
- Primary Endpoint
- Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Other find tumor cells and help kill them or carry tumor-killing substances to them. Giving panitumumab together with paclitaxel and carboplatin may be a better way to block tumor growth.
PURPOSE: This phase II trial is studying the side effects and how well paclitaxel and carboplatin together with panitumumab works in treating patients with metastatic triple negative breast cancer.
Detailed Description
PRIMARY OBJECTIVE: I. To determine the response rate to the combination of carboplatin, paclitaxel and panitumumab in women with ER-, PR- and Her-2 negative metastatic breast cancer. SECONDARY OBJECTIVES: I. To determine the tolerability and toxicities of the combination of paclitaxel, carboplatin and panitumumab. II. To determine the markers that co-occur with EGFR expression in the triple negative breast cancer. III. To assess the association between tumor biomarkers and clinical outcomes (response and survival). IV. To examine the effect this regimen has on time to progression and survival. OUTLINE: Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
Arm 1
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
Intervention: panitumumab
Arm 1
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
Intervention: paclitaxel
Arm 1
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
Intervention: carboplatin
Arm 1
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
Intervention: laboratory biomarker analysis
Arm 1
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
Intervention: immunohistochemistry staining method
Outcomes
Primary Outcomes
Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria
Time Frame: every 28 days for a minimum of 84 days
Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.
Secondary Outcomes
- Survival(Approximately 7 months)
- Time to Progression(Approximately 7 months)
- Expression of EGFR and Other Protein Markers(baseline)