Clinical trial NCT00303108: Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer
Official title: Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Metastatic Breast Cancer
Lead sponsor: US Oncology Research
Sponsor class: INDUSTRY
Collaborators: name: Ortho Biotech, Inc.
name: Tibotec Pharmaceutical Limited
First posted: 2006-03-15
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.
Secondary outcomes:
measure: Duration of Response
timeFrame: From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.
measure: Progression-free Survival (PFS)
timeFrame: 30 months
measure: 1-year Overall Survival
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology
state: Alabama
city: Phoenix
country: United States
facility: Hematology Oncology Associates
state: Arizona
city: Sedona
country: United States
facility: Northern AZ Hematology & Oncology Associates-Sedona
state: Arizona
city: Denver
country: United States
facility: Rocky Mountain Cancer Center-Rose
state: Colorado
city: New Port Richey
country: United States
facility: Florida Cancer Institute
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Chicago
country: United States
facility: Hematology Oncology Associates of IL
state: Illinois
city: Niles
country: United States
facility: Cancer Care & Hematology Specialists of Chicagoland, PC
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Cancer Centers-Southwest
state: Kansas
city: Columbia
country: United States
facility: Maryland Oncology Hematology, PA
state: Maryland
city: Westminster
country: United States
facility: Flavio Kruter, MD, PA
state: Maryland
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Las Vegas
country: United States
facility: Comprehensive Cancer Centers of Nevada
state: Nevada
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: New York
country: United States
facility: Ruth Oratz MD
state: New York
city: Cary
country: United States
facility: Raleigh Hematology Oncology Associates
state: North Carolina
city: Kettering
country: United States
facility: Greater Dayton Cancer Center
state: Ohio
city: Eugene
country: United States
facility: Willamette Vallejy Cancer Center
state: Oregon
city: Kingston
country: United States
facility: Medical Oncology Associates
state: Pennsylvania
city: Abilene
country: United States
facility: Texas Cancer Center - Abilene (South)
state: Texas
city: Amarillo
country: United States
facility: Texas Oncology, P.A.-Amarillo
state: Texas
city: Arlington
country: United States
facility: Texas Cancer Center
state: Texas
city: Beaumont
country: United States
facility: Mamie McFaddin Ward Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, PA-Bedford
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Dallas
country: United States
facility: The TexasCancer Center
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Denton
country: United States
facility: Texas Cancer Center-Denton
state: Texas
city: El Paso
country: United States
facility: El Paso Cancer Treatment Ctr
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, PA
state: Texas
city: Garland
country: United States
facility: Texas Oncology, PA
state: Texas
city: Houston
country: United States
facility: Texas Oncology, PA
state: Texas
city: Lewisville
country: United States
facility: Lake Vista Cancer Center
state: Texas
city: Longview
country: United States
facility: Longview Cancer Center
state: Texas
city: McAllen
country: United States
facility: South Texas Cancer Center-McAllen
state: Texas
city: Mesquite
country: United States
facility: Texas Cancer Center of Mesquite
state: Texas
city: Midland
country: United States
facility: Alison Cancer Center
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: Paris
country: United States
facility: Paris Regional Cancer Center
state: Texas
city: San Antonio
country: United States
facility: HOAST-Medical Dr.
state: Texas
city: Sherman
country: United States
facility: Texas Cancer Center-Sherman
state: Texas
city: Sugar Land
country: United States
facility: Texas Oncology Cancer Center-Sugar Land
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Texas Oncology Cancer Care and Research Center-Waco
state: Texas
city: Webster
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Fairfax
country: United States
facility: Fairfax Northern VA Hem-Onc PC
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Onc and Hem Associates of SW VA, Inc
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Center-Edmonds
state: Washington
city: Seattle
country: United States
facility: Puget Sound Cancer Center-Seattle
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest-North
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists-Vancouver
state: Washington
city: Yakima
country: United States
facility: Yakima Valley Mem Hosp/North Star Lodge
state: Washington
Study officials:
affiliation: US Oncology Research
name: Rufus P Collea, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.