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Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00303108
Recruitment Status : Completed
First Posted : March 15, 2006
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Sponsor:
Collaborators:
Ortho Biotech, Inc.
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
US Oncology Research

Tracking Information
First Submitted Date  ICMJE March 13, 2006
First Posted Date  ICMJE March 15, 2006
Results First Submitted Date  ICMJE February 2, 2016
Results First Posted Date  ICMJE November 3, 2016
Last Update Posted Date November 3, 2016
Study Start Date  ICMJE December 2005
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
Objective Response Rate (ORR) [ Time Frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months. ]
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Objective response (OR) = CR + PR.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00303108 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2016)
  • Duration of Response [ Time Frame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months. ]
    Duration from date of stating treatment to the date of first CR or PR.
  • Progression-free Survival (PFS) [ Time Frame: 30 months ]
    PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date. Progression is defined as appearance of one or more new lesions. Unequivocal progression of existing non-target lesions. Although a clear progression of "non-target" lesions only is exceptional, in such circumstances, the opinion of the Treating Physician should prevail, and the progression status should be confirmed at a later time by the review panel.
  • 1-year Overall Survival [ Time Frame: 1 year ]
    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer
Official Title  ICMJE Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer
Brief Summary The purpose of this study is to determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Breast Cancer
Intervention  ICMJE
  • Drug: Pegylated liposomal doxorubicin
    30 mg/m2 IV on Day 1 of each 28 day cycle
    Other Name: Doxil
  • Drug: Carboplatin
    AUC=5 on Day 1 of each 28 day cycle
  • Drug: trastuzumab
    4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)
    Other Name: Herceptin
Study Arms  ICMJE Experimental: Arm 1
Patients will receive IV Doxil 30 mg/m2 and carboplatin AUC=5 on Day 1 of each cycle. A cycle consists of 28 days. In addition, HER2+ (IHC3+ and FISH+) patients only will receive a one-time loading dose of Herceptin 8 mg/kg IV on Day 1 of Cycle 1 and 4 mg/kg on Day 1 and Day 15 of every cycle thereafter.
Interventions:
  • Drug: Pegylated liposomal doxorubicin
  • Drug: Carboplatin
  • Drug: trastuzumab
Publications * Collea RP, Kruter FW, Cantrell JE, George TK, Kruger S, Favret AM, Lindquist DL, Melnyk AM, Pluenneke RE, Shao SH, Crockett MW, Asmar L, O'Shaughnessy J. Pegylated liposomal doxorubicin plus carboplatin in patients with metastatic breast cancer: a phase II study. Ann Oncol. 2012 Oct;23(10):2599-605. Epub 2012 Mar 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 15, 2016)
136
Original Enrollment  ICMJE
 (submitted: March 13, 2006)
135
Actual Study Completion Date  ICMJE June 2011
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Has metastatic breast cancer with documented HER2- or HER2+ (IHC3+ or FISH+) disease
  • Has measurable MBC, with at least 1 measurable lesion per RECIST criteria (see Section 10). Irradiated lesions cannot be used to assess response but can be used to assess progression.
  • Has had no prior treatment with Doxil or carboplatin; may have had adjuvant Herceptin if treatment was completed more than 1 year prior to study
  • Has had no adjuvant chemotherapy within 1 year prior to study, but may have received prior anthracyclines as adjuvant chemotherapy
  • For taxane-pretreated patients (adjuvant or metastatic), has had no more than 1 prior chemotherapy regimen for MBC
  • For taxane-naïve patients, has had no prior chemotherapy for MBC
  • Has had cumulative doses of < 300 mg/m2 prior doxorubicin or < 450 mg/m2 prior epirubicin
  • Has normal cardiac function as evidenced by a LVEF within institutional normal limits by multiple gated acquisition (MUGA) scan. An echocardiogram (ECHO) may be used if MUGA is not available, but the same test must be used throughout the study to evaluate LVEF.
  • Has an ECOG Performance Status (PS) 0-2 (see Appendix I)
  • Is a male or female greater than or equal to 18 years of age
  • Laboratory Values - Please refer to protocol section 4.2 for specific laboratory values.
  • Has a negative serum pregnancy test within 7 days prior to registration (woman of childbearing potential [WOCBP; not surgically sterilized and between menarche and 1 year postmenopause])
  • If fertile, patient (male or female) has agreed to use an acceptable method of birth control (eg, abstinence, intrauterine device, oral contraceptives, barrier device with spermicide or surgical sterilization) to avoid pregnancy for the duration of the study and for a period of 3 months thereafter.
  • Has signed a Patient Informed Consent Form
  • Has signed a Patient Authorization Form (HIPAA Form)
  • Has a life expectancy of > 3 months

Exclusion Criteria:

  • Has had a myocardial infarction (MI) within 6 months of trial enrollment, or has New York Heart Association (NYHA; see Appendix IV) Class II or greater heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities
  • Has a history of hypersensitivity reactions attributed to a conventional formulation of doxorubicin HCL or the components of Doxil
  • Has evaluable only disease; eg, bone only, pleural, peritoneal only disease
  • Is receiving concurrent immunotherapy, hormonal therapy, or radiation therapy. Patients receiving immunosuppressant therapy for autoimmune disease may enroll on the trial after a drug washout period of 2 weeks.
  • Is receiving concurrent investigational therapy or has received such therapy within 30 days
  • Has evidence of brain metastases requiring steroids and/or radiation or any documented leptomeningeal disease
  • Has a serious uncontrolled intercurrent medical or psychiatric illness, including serious infection or history of uncontrolled seizures, CNS disorders deemed by the Treating Physician to be clinically significant, precluding informed consent
  • Has a history of other malignancy within the last 5 years (except cured basal cell carcinoma of skin and carcinoma in situ of uterine cervix), which could affect the diagnosis or assessment of any of the study drugs
  • Is a pregnant or lactating woman
  • Is unable to comply with requirements of study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00303108
Other Study ID Numbers  ICMJE 04111
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party US Oncology Research
Study Sponsor  ICMJE US Oncology Research
Collaborators  ICMJE
  • Ortho Biotech, Inc.
  • Tibotec Pharmaceutical Limited
Investigators  ICMJE
Principal Investigator: Rufus P Collea, MD US Oncology Research
PRS Account US Oncology Research
Verification Date September 2016

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