Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Treatments: Albumin-Bound Paclitaxel; Antibodies, Monoclonal; Carboplatin; Paclitaxel; Panitumumab

Criteria

Inclusion

• Pathologically confirmed invasive breast cancer with ER < 10%, PR < 10%, by IHC, HER2 1+ or 0 or FISH negative

• Measurable (>= 1 cm) or assessable disease detectable by imagining or physical exam

• Patients with bone only disease have measurable lesions on x-ray, MRI, or CT scan

• Only one or no prior therapy for metastatic or recurrent breast cancer is allowed

• Prior chemotherapy or radiation therapy is permitted but at least 2 weeks should elapse prior to study enrollment

• Prior therapy with bevacizumab is permitted but at least 2 weeks should elapse prior to study enrollment

• Prior therapy with bevacizumab is permitted but at least 28 days should elapse from the last bevacizumab treatment prior to study enrollment

• ECOG PS or 0-1

• Signed protocol specific informed consent prior to registration

• Life expectancy greater than 3 months

• Please contact study investigator and/or consult the protocol document for specific laboratory criteria

• Tissue block available from primary breast cancer

• Premenopausal women must have a negative serum or urine pregnancy test prior to starting on study treatment (post-menopausal is defined as > 6 months of amenorrhea prior hysterectomy)

Exclusion

• More than or equal to 2 prior regimens for metastatic breast cancer

• Leptomeningeal disease

• Brain metastasis except for a solitary lesion that was resected or treated with gamma knife with no residual disease on CT or MRI or received whole brain RT and f/u MRI was normal with no residual neurologic deficit

• History of interstitial lung disease (ie pneumonitis, pulmonary fibrosis) or evidence of interstitial lung disease on baseline chest computerized tomography (CT) scan

• History of irreversible neuropathy

• Another malignancy other than carcinoma in situ of the cervix or skin cancer

• Active uncontrolled bacterial viral or fungal infection

• Active pregnancy or breast feeding

• Patients with pre-existing neuropathy >= grade 2

• History of myocardial infarction, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

• Patients with previous history of CTCAE grade >= 3 hypersensitivity to paclitaxel or Cremophor EL are not eligible