Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Ortho Biotech, Inc.
Tibotec Pharmaceutical Limited
Information provided by (Responsible Party):
US Oncology Research
ClinicalTrials.gov Identifier:
NCT00303108
First received: March 13, 2006
Last updated: July 19, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Pegylated liposomal doxorubicin
Drug: Carboplatin
Drug: trastuzumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer

Resource links provided by NLM:


Further study details as provided by US Oncology Research:

Primary Outcome Measures:
  • Primary Objective [ Designated as safety issue: No ]
    To determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC)


Enrollment: 135
Study Start Date: December 2005
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00303108

  Show 57 Study Locations
Sponsors and Collaborators
US Oncology Research
Ortho Biotech, Inc.
Tibotec Pharmaceutical Limited
Investigators
Principal Investigator: Rufus P Collea, MD US Oncology Research
  More Information

No publications provided by US Oncology Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: US Oncology Research
ClinicalTrials.gov Identifier: NCT00303108     History of Changes
Other Study ID Numbers: 04111
Study First Received: March 13, 2006
Last Updated: July 19, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
Trastuzumab
Carboplatin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 23, 2014