This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Bristol-Myers Squibb
Avon Foundation
National Center for Research Resources (NCRR)
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00232505
First received: October 3, 2005
Last updated: March 15, 2017
Last verified: March 2017
October 3, 2005
March 15, 2017
November 2005
June 21, 2010   (Final data collection date for primary outcome measure)
Overall disease response rate [ Time Frame: every 8 weeks ]
Overall response rate of single agent cetuximab and cetuximab + carboplatin will be measured by radigographic response using RECIST criteria every 8 weeks until subject experiences disease progression. Overall response will be measured as complete response (CR), partial response (PR), stable disease (SD) or progressive disease (PD).
- Overall response rate to single agent cetuximab and to combination cetuximab plus carboplatin
Complete list of historical versions of study NCT00232505 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: every 4 months ]
    Subjects will be contacted every 4 months after discontinuation of active treatment to assess survival.
  • Time to progression [ Time Frame: every 8 weeks ]
    Time to disease progression of cetuximab or cetuximab + carboplatin as indicated by radiographic assessment
  • - Time to disease progression
  • - To correlate downstream effects of EGFR inhibitor on MAPK, AKT, Ki67 and EGFR-dependent signaling, proliferation, and apoptosis and correlate these with toxicity and response in patients with accessible tumors.
  • - To examine changes in above markers and gene expression in circulating tumor cells during therapy
  • - Overall survival
Not Provided
Not Provided
 
Cetuximab + / - Carboplatin for Estrogen Receptor-Negative, Progesterone Receptor-Negative Metastatic Breast Cancer
Phase II Trial of Cetuximab Alone and in Combination With Carboplatin in ER-Negative, PR-Negative, HER-2 Nonoverexpressing Metastatic Breast Cancer

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cetuximab together with carboplatin is more effective than giving cetuximab alone in treating metastatic breast cancer.

PURPOSE: This randomized phase II trial is studying cetuximab and carboplatin to see how well they work compared with cetuximab alone in treating women with estrogen receptor-negative (ER-), progesterone receptor-negative (PR-) metastatic breast cancer.

OBJECTIVES:

Primary

  • Compare the overall response rate in women with estrogen receptor-negative, progesterone receptor-negative, HER2-nonoverexpressing metastatic breast cancer treated with cetuximab with vs without carboplatin.

Secondary

  • Compare the time to disease progression in patients treated with these regimens.
  • Correlate downstream effects of EGFR inhibitor on MAPK, AKT, Ki67, and EGFR-dependent signaling, proliferation, and apoptosis with toxicity and response in patients with accessible tumors treated with these regimens.
  • Determine the changes in biomarkers and gene expression in circulating tumor cells during treatment.
  • Compare the overall survival rate in patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive cetuximab IV over 60-120 minutes once a week.
  • Arm II: Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15.

In both arms, treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment in arm I may cross over to arm II.

Blood samples are collected periodically throughout study for correlative biomarker analysis by IHC and gene expression analysis.

After completion of study treatment, patients are followed every 4 months.

Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Outcomes Assessor
Primary Purpose: Treatment
Breast Cancer
  • Biological: cetuximab
    Given IV
    Other Name: Erbitux
  • Drug: carboplatin
    Given IV
    Other Name: Paraplatin
  • Experimental: Arm I
    Patients receive cetuximab IV over 60-120 minutes once a week. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients not responding to treatment may cross over to arm II.
    Intervention: Biological: cetuximab
  • Experimental: Arm II
    Patients receive cetuximab as in arm I and carboplatin IV on days 1, 8, and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
    Interventions:
    • Biological: cetuximab
    • Drug: carboplatin
Oliveras-Ferraros C, Vazquez-Martin A, López-Bonet E, Martín-Castillo B, Del Barco S, Brunet J, Menendez JA. Growth and molecular interactions of the anti-EGFR antibody cetuximab and the DNA cross-linking agent cisplatin in gefitinib-resistant MDA-MB-468 cells: new prospects in the treatment of triple-negative/basal-like breast cancer. Int J Oncol. 2008 Dec;33(6):1165-76.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
112
August 12, 2012
June 21, 2010   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed breast cancer

    • Metastatic (stage IV) disease
  • Measurable disease by RECIST criteria

    • Irradiated lesions are not considered measurable disease
  • CNS metastases allowed if disease is stable (no evidence of progression) ≥ 3 months after local therapy
  • No lesions identifiable only by PET scan
  • HER2 nonoverexpressing disease by IHC (0 or 1) or non-gene amplified by FISH

    • HER2 2+ by IHC allowed
  • Hormone receptor status:

    • Estrogen receptor-negative and progesterone receptor-negative tumor

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-2
  • Life expectancy ≥ 6 months
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine clearance ≥ 50 mL/min
  • ALT and AST ≤ 2.5 times upper limit of normal (ULN) (≤ 5 times ULN in case of liver metastases)
  • Bilirubin ≤ 1.5 mg/dL
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No significant history of uncontrolled cardiac disease including, but not limited to, any of the following:

    • Uncontrolled hypertension
    • Unstable angina
    • Recent myocardial infarction (within the past 6 months)
    • Uncontrolled congestive heart failure
    • Cardiomyopathy that is either symptomatic or asymptomatic but with decreased ejection fraction < 45%
  • No history of severe infusion reaction to monoclonal antibody treatment
  • No uncontrolled infection
  • No major medical condition (i.e., uncontrolled pulmonary, renal, or hepatic dysfunction) that may affect study participation
  • No other significant comorbid condition that may compromise effective and safe participation in the study

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 3 weeks since prior chemotherapy
  • At least 2 weeks since prior radiation therapy
  • No more than 3 prior chemotherapy regimens either in the adjuvant or metastatic setting

    • Sequential regimens (e.g., anthracycline-paclitaxel) are considered 1 regimen
  • No prior therapy that specifically and directly targets the EGFR pathway with therapeutic intent
  • No prior platinum agent for metastatic disease
  • Prior platinum agents in the adjuvant setting allowed provided there was a disease-free interval that lasted for ≥ 12 months prior to relapse
  • Concurrent bisphosphonates allowed

    • Bone lesions may not be used to measure progression or response
Sexes Eligible for Study: Female
18 Years to 120 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00232505
LCCC 0403
M01RR000046 ( US NIH Grant/Contract Award Number )
CA058223 ( Other Grant/Funding Number: NCI OSP/SPOREs )
Yes
Not Provided
Not Provided
Not Provided
UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
  • National Cancer Institute (NCI)
  • Bristol-Myers Squibb
  • Avon Foundation
  • National Center for Research Resources (NCRR)
Principal Investigator: Lisa A. Carey, MD UNC Lineberger Comprehensive Cancer Center
UNC Lineberger Comprehensive Cancer Center
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP