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

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ClinicalTrials.gov Identifier: NCT01009983
Recruitment Status : Terminated (Slow accrual)
First Posted : November 9, 2009
Results First Posted : June 18, 2014
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):

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
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
Primary Completion Date : July 2013
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

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. Toxicity According to CTCAE v3.0 [ Time Frame: monthly ]
  2. Time to Progression [ Time Frame: monthly ]
  3. Survival [ Time Frame: monthly ]
  4. Expression of EGFR and Other Protein Markers [ Time Frame: baseline ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01009983


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     History of Changes
Other Study ID Numbers: CCCWFU74108
NCI-2009-01257 ( Other Identifier: CTRP )
First Posted: November 9, 2009    Key Record Dates
Results First Posted: June 18, 2014
Last Update Posted: June 20, 2017
Last Verified: February 2017

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
Albumin-Bound Paclitaxel
Carboplatin
Antibodies, Monoclonal
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs