Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer
NCT ID: NCT00303108
Last Updated: 2016-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
136 participants
INTERVENTIONAL
2005-12-31
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Pegylated liposomal doxorubicin
30 mg/m2 IV on Day 1 of each 28 day cycle
Carboplatin
AUC=5 on Day 1 of each 28 day cycle
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)
Interventions
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Pegylated liposomal doxorubicin
30 mg/m2 IV on Day 1 of each 28 day cycle
Carboplatin
AUC=5 on Day 1 of each 28 day cycle
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Ortho Biotech, Inc.
INDUSTRY
Tibotec Pharmaceutical Limited
INDUSTRY
US Oncology Research
INDUSTRY
Responsible Party
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Principal Investigators
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Rufus P Collea, MD
Role: PRINCIPAL_INVESTIGATOR
US Oncology Research
Locations
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Birmingham Hematology and Oncology
Birmingham, Alabama, United States
Hematology Oncology Associates
Phoenix, Arizona, United States
Northern AZ Hematology & Oncology Associates-Sedona
Sedona, Arizona, United States
Rocky Mountain Cancer Center-Rose
Denver, Colorado, United States
Florida Cancer Institute
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Hematology Oncology Associates of IL
Chicago, Illinois, United States
Cancer Care & Hematology Specialists of Chicagoland, PC
Niles, Illinois, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, United States
Kansas City Cancer Centers-Southwest
Overland Park, Kansas, United States
Maryland Oncology Hematology, PA
Columbia, Maryland, United States
Flavio Kruter, MD, PA
Westminster, Maryland, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, United States
Missouri Cancer Associates
Columbia, Missouri, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, United States
New York Oncology Hematology, PC
Albany, New York, United States
Ruth Oratz MD
New York, New York, United States
Raleigh Hematology Oncology Associates
Cary, North Carolina, United States
Greater Dayton Cancer Center
Kettering, Ohio, United States
Willamette Vallejy Cancer Center
Eugene, Oregon, United States
Medical Oncology Associates
Kingston, Pennsylvania, United States
Texas Cancer Center - Abilene (South)
Abilene, Texas, United States
Texas Oncology, P.A.-Amarillo
Amarillo, Texas, United States
Texas Cancer Center
Arlington, Texas, United States
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States
Texas Oncology, PA-Bedford
Bedford, Texas, United States
Texas Cancer Center at Medical City
Dallas, Texas, United States
Texas Oncology, PA
Dallas, Texas, United States
The TexasCancer Center
Dallas, Texas, United States
Texas Oncology, PA
Dallas, Texas, United States
Texas Cancer Center-Denton
Denton, Texas, United States
El Paso Cancer Treatment Ctr
El Paso, Texas, United States
Texas Oncology, PA
Fort Worth, Texas, United States
Texas Oncology, PA
Garland, Texas, United States
Texas Oncology, PA
Houston, Texas, United States
Lake Vista Cancer Center
Lewisville, Texas, United States
Longview Cancer Center
Longview, Texas, United States
South Texas Cancer Center-McAllen
McAllen, Texas, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, United States
Alison Cancer Center
Midland, Texas, United States
West Texas Cancer Center
Odessa, Texas, United States
Paris Regional Cancer Center
Paris, Texas, United States
HOAST-Medical Dr.
San Antonio, Texas, United States
Texas Cancer Center-Sherman
Sherman, Texas, United States
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Texas Oncology Cancer Care and Research Center-Waco
Waco, Texas, United States
Texas Oncology, P.A.
Webster, Texas, United States
Fairfax Northern VA Hem-Onc PC
Fairfax, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Onc and Hem Associates of SW VA, Inc
Salem, Virginia, United States
Puget Sound Cancer Center-Edmonds
Edmonds, Washington, United States
Puget Sound Cancer Center-Seattle
Seattle, Washington, United States
Cancer Care Northwest-North
Spokane, Washington, United States
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, United States
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States
Countries
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References
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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):2599-2605. doi: 10.1093/annonc/mds052. Epub 2012 Mar 19.
Other Identifiers
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04111
Identifier Type: -
Identifier Source: org_study_id