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

• ClinicalTrials.gov Identifier: NCT01009983
• Recruitment Status: Terminated
• First Posted: November 9, 2009
• Results First Posted: June 18, 2014
• Last Update Posted: July 6, 2018
• Sponsor: Wake Forest University Health Sciences
• Information provided by (Responsible Party): Wake Forest University Health Sciences

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer	Biological: panitumumab; Drug: paclitaxel; Drug: carboplatin; Procedure: laboratory biomarker analysis; Procedure: immunohistochemistry staining method	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: March 2010
• Actual Primary Completion Date: July 2013
• Actual Study Completion Date: December 2013

Arms and Interventions

Arm

Intervention/treatment

Experimental: 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.

Biological: panitumumab; Given IV; Other Names: ABX-EGF; clone E7.6.3; MOAB ABX-EGF; monoclonal antibody ABX-EGF; Vectibix; Drug: paclitaxel; Given IV; Other Names: Anzatax; Asotax; Bristaxol; Praxel; TAX; Taxol; Drug: carboplatin; Given IV; Other Names: Carboplat; CBDCA; JM-8; Paraplat; Paraplatin; Paraplatine; Procedure: laboratory biomarker analysis; Correlative study; Procedure: immunohistochemistry staining method; Correlative study; Other Name: immunohistochemistry

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Time to Progression [ Time Frame: Approximately 7 months ]
   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.
2. Survival [ Time Frame: Approximately 7 months ]
3. Expression of EGFR and Other Protein Markers [ Time Frame: baseline ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Louisiana

Ochsner Clinic Foundation

New Orleans, Louisiana, United States, 70115

United States, North Carolina

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States, 27157

Sponsors and Collaborators

Wake Forest University Health Sciences

Investigators

• Principal Investigator: Heidi D Klepin; Wake Forest University Health Sciences

More Information

• Responsible Party: Wake Forest University Health Sciences
• ClinicalTrials.gov Identifier: NCT01009983
• Other Study ID Numbers: IRB00010510; NCI-2009-01257 ( Other Identifier: CTRP ); CCCWFU74108 ( Other Identifier: Wake Forest University Health Sciences )
• First Posted: November 9, 2009
• Results First Posted: June 18, 2014
• Last Update Posted: July 6, 2018
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wake Forest University Health Sciences:

triple-negative breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Paclitaxel; Carboplatin; Panitumumab; Antineoplastic Agents, Phytogenic; Antineoplastic Agents; Tubulin Modulators; Antimitotic Agents; Mitosis Modulators; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents, Immunological