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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01009983
• Other study ID #: IRB00010510
• Secondary ID: NCI-2009-01257CC
• Status: Terminated
• Phase: Phase 2
• Start date: March 2010
• Est. completion date: December 2013

Study information

• Verified date: July 2018
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: December 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Recurrent Breast Cancer
• Stage IV Breast Cancer

Intervention

Biological:
• panitumumab
Given IV

Drug:
• paclitaxel
Given IV
• carboplatin
Given IV

Procedure:
• laboratory biomarker analysis
Correlative study
• immunohistochemistry staining method
Correlative study

Locations

Country	Name	City	State
United States	Ochsner Clinic Foundation	New Orleans	Louisiana
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria	Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.	every 28 days for a minimum of 84 days
Secondary	Time to Progression	Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.	Approximately 7 months
Secondary	Survival		Approximately 7 months
Secondary	Expression of EGFR and Other Protein Markers		baseline