Clinical trial NCT01009983: Paclitaxel, Carboplatin, and Panitumumab in Treating Patients With Metastatic Breast Cancer
Official title: A Phase II Clinical Trial of Weekly Paclitaxel and Carboplatin in Combination With Panitumumab in Metastatic Breast Cancer Patients With Triple Negative Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Recurrent Breast Cancer
Stage IV Breast Cancer
Keywords: triple-negative breast cancer
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2009-11-09
Enrollment: 14
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria
timeFrame: every 28 days for a minimum of 84 days
Secondary outcomes:
measure: Time to Progression
timeFrame: Approximately 7 months
measure: Survival
timeFrame: Approximately 7 months
measure: Expression of EGFR and Other Protein Markers
timeFrame: baseline
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Heidi D Klepin
role: PRINCIPAL_INVESTIGATOR
References: