Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

Official title:

Phase II Study of Doxil and Carboplatin, Plus Herceptin in HER2+ Patients, in Metastatic Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00303108
• Other study ID #: 04111
• Status: Completed
• Phase: Phase 2
• First received: March 13, 2006
• Last updated: July 19, 2013
• Start date: December 2005
• Est. completion date: March 2010

Study information

• Verified date: July 2013
• Source: US Oncology Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
United States	Texas Cancer Center - Abilene (South)	Abilene	Texas
United States	New York Oncology Hematology, PC	Albany	New York
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	Birmingham Hematology and Oncology	Birmingham	Alabama
United States	Raleigh Hematology Oncology Associates	Cary	North Carolina
United States	Hematology Oncology Associates of IL	Chicago	Illinois
United States	Maryland Oncology Hematology, PA	Columbia	Maryland
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Texas Cancer Center at Medical City	Dallas	Texas
United States	Texas Oncology, PA	Dallas	Texas
United States	Texas Oncology, PA	Dallas	Texas
United States	The TexasCancer Center	Dallas	Texas
United States	Texas Cancer Center-Denton	Denton	Texas
United States	Rocky Mountain Cancer Center-Rose	Denver	Colorado
United States	Puget Sound Cancer Center-Edmonds	Edmonds	Washington
United States	El Paso Cancer Treatment Ctr	El Paso	Texas
United States	Willamette Vallejy Cancer Center	Eugene	Oregon
United States	Fairfax Northern VA Hem-Onc PC	Fairfax	Virginia
United States	Texas Oncology, PA	Fort Worth	Texas
United States	Texas Oncology, PA	Garland	Texas
United States	Texas Oncology, PA	Houston	Texas
United States	Central Indiana Cancer Centers	Indianapolis	Indiana
United States	Greater Dayton Cancer Center	Kettering	Ohio
United States	Medical Oncology Associates	Kingston	Pennsylvania
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
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	Minnesota Oncology Hematology, PA	Minneapolis	Minnesota
United States	Florida Cancer Institute	New Port Richey	Florida
United States	Ruth Oratz MD	New York	New York
United States	Cancer Care & Hematology Specialists of Chicagoland, PC	Niles	Illinois
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Ocala Oncology Center	Ocala	Florida
United States	West Texas Cancer Center	Odessa	Texas
United States	Kansas City Cancer Centers-Southwest	Overland Park	Kansas
United States	Paris Regional Cancer Center	Paris	Texas
United States	Hematology Oncology Associates	Phoenix	Arizona
United States	Onc and Hem Associates of SW VA, Inc	Salem	Virginia
United States	HOAST-Medical Dr.	San Antonio	Texas
United States	New Mexico Cancer Care Associates	Santa Fe	New Mexico
United States	Puget Sound Cancer Center-Seattle	Seattle	Washington
United States	Northern AZ Hematology & Oncology Associates-Sedona	Sedona	Arizona
United States	Texas Cancer Center-Sherman	Sherman	Texas
United States	Cancer Care Northwest-North	Spokane	Washington
United States	Texas Oncology Cancer Center-Sugar Land	Sugar Land	Texas
United States	Tyler Cancer Center	Tyler	Texas
United States	Northwest Cancer Specialists-Vancouver	Vancouver	Washington
United States	Texas Oncology Cancer Care and Research Center-Waco	Waco	Texas
United States	Texas Oncology, P.A.	Webster	Texas
United States	Flavio Kruter, MD, PA	Westminster	Maryland
United States	Yakima Valley Mem Hosp/North Star Lodge	Yakima	Washington

Sponsors (3)

Lead Sponsor	Collaborator
US Oncology Research	Ortho Biotech, Inc., Tibotec Pharmaceutical Limited

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Objective	To determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC)		No