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

NCT01009983 | Terminated Phase 2 Results FDA Drug

• 3 other identifiers: IRB00010510NCI-2009-01257CCCWFU74108
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Recurrent Breast Cancer; Stage IV Breast Cancer

Keywords

triple-negative breast cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Time to Progression

  Approximately 7 months

• Survival

  Approximately 7 months

• Expression of EGFR and Other Protein Markers

  baseline

Study Arms (1)

Arm 1

EXPERIMENTAL

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; Drug: paclitaxel; Drug: carboplatin; Procedure: laboratory biomarker analysis; Procedure: immunohistochemistry staining method

Interventions

panitumumab BIOLOGICAL

Given IV

Also known as: ABX-EGF, clone E7.6.3, MOAB ABX-EGF, monoclonal antibody ABX-EGF, Vectibix

Arm 1

paclitaxel DRUG

Given IV

Also known as: Anzatax, Asotax, Bristaxol, Praxel, TAX, Taxol

Arm 1

carboplatin DRUG

Given IV

Also known as: Carboplat, CBDCA, JM-8, Paraplat, Paraplatin, Paraplatine

Arm 1

laboratory biomarker analysis PROCEDURE

Correlative study

Arm 1

immunohistochemistry staining method PROCEDURE

Correlative study

Also known as: immunohistochemistry

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (2)

Ochsner Clinic Foundation

New Orleans, Louisiana, 70115, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Panitumumab; Paclitaxel; Taxes; Carboplatin; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Economics; Health Care Economics and Organizations; Coordination Complexes; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques

Limitations and Caveats

the worst adverse event of each type was recorded for the course of treatment

Results Point of Contact

• Title: Dr. Susan Melin
• Organization: Wake Forest University Health Sciences

smelin@wakehealth.edu

336-716-2839

Study Officials

• Heidi D Klepin

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2009
• First Posted: November 9, 2009
• Study Start: March 1, 2010
• Primary Completion: July 1, 2013
• Study Completion: December 1, 2013
• Last Updated: July 6, 2018
• Results First Posted: June 18, 2014

Record last verified: 2018-07

Locations

US (2)