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

Primary Purpose

Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
panitumumab
paclitaxel
carboplatin
laboratory biomarker analysis
immunohistochemistry staining method
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring triple-negative breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ochsner Clinic Foundation
  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Survival
Expression of EGFR and Other Protein Markers

Full Information

First Posted
November 6, 2009
Last Updated
July 3, 2018
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01009983
Brief Title
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

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Terminated
Why Stopped
Slow accrual
Study Start Date
March 2010 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Recurrent Breast Cancer, Stage IV Breast Cancer
Keywords
triple-negative breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Patients receive paclitaxel IV and carboplatin IV on days 1, 8, and 15. Patients also receive panitumumab IV on days 1 and 15.
Intervention Type
Biological
Intervention Name(s)
panitumumab
Other Intervention Name(s)
ABX-EGF, clone E7.6.3, MOAB ABX-EGF, monoclonal antibody ABX-EGF, Vectibix
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Other Intervention Name(s)
Anzatax, Asotax, Bristaxol, Praxel, TAX, Taxol
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
carboplatin
Other Intervention Name(s)
Carboplat, CBDCA, JM-8, Paraplat, Paraplatin, Paraplatine
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
laboratory biomarker analysis
Intervention Description
Correlative study
Intervention Type
Procedure
Intervention Name(s)
immunohistochemistry staining method
Other Intervention Name(s)
immunohistochemistry
Intervention Description
Correlative study
Primary Outcome Measure Information:
Title
Antitumor Activity as Assessed by Objective Tumor Response According to RECIST Criteria
Description
Complete or Partial response as defined by reduction in tumor size according to RECIST (Response Evaluation Criteria In Solid Tumors) rules.
Time Frame
every 28 days for a minimum of 84 days
Secondary Outcome Measure Information:
Title
Time to Progression
Description
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.
Time Frame
Approximately 7 months
Title
Survival
Time Frame
Approximately 7 months
Title
Expression of EGFR and Other Protein Markers
Time Frame
baseline

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heidi D Klepin
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ochsner Clinic Foundation
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

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

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