Doxil & Carboplatin Plus HER2+ in Metastatic Breast Cancer

NCT00303108 | Completed Phase 2 Results

• 1 other identifier: 04111
• Study Type: interventional
• Target: 136
• Locations: 1 country
• Sites: 57

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).

Conditions

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  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.

  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 (3)

• Duration of Response

  From date of randomization until the date of first documented progression or date of intolerable toxicity, whichever came first, assessed up to 54 months.

• Progression-free Survival (PFS)

  30 months

• 1-year Overall Survival

  1 year

Study Arms (1)

Arm 1

EXPERIMENTAL

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; Drug: Carboplatin; Drug: trastuzumab

Interventions

Pegylated liposomal doxorubicin DRUG

30 mg/m2 IV on Day 1 of each 28 day cycle

Also known as: Doxil

Arm 1

Carboplatin DRUG

AUC=5 on Day 1 of each 28 day cycle

Arm 1

trastuzumab DRUG

4 mg/kg on Days 1 and 15 of each cycle(loading dose of 8 mg/kg on Day 1 of Cycle 1 only)

Also known as: Herceptin

Arm 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• US Oncology Research: lead
• Ortho Biotech, Inc.: collaborator
• Tibotec Pharmaceutical Limited: collaborator

Study Sites (57)

Birmingham Hematology and Oncology

Birmingham, Alabama, 35205, United States

Location

Hematology Oncology Associates

Phoenix, Arizona, 85012, United States

Location

Northern AZ Hematology & Oncology Associates-Sedona

Sedona, Arizona, 86336, United States

Location

Rocky Mountain Cancer Center-Rose

Denver, Colorado, 80220, United States

Location

Florida Cancer Institute

New Port Richey, Florida, 34655, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Hematology Oncology Associates of IL

Chicago, Illinois, 60611, United States

Location

Cancer Care & Hematology Specialists of Chicagoland, PC

Niles, Illinois, 60714, United States

Location

Central Indiana Cancer Centers

Indianapolis, Indiana, 46227, United States

Location

Kansas City Cancer Centers-Southwest

Overland Park, Kansas, 66210, United States

Location

Maryland Oncology Hematology, PA

Columbia, Maryland, 21044, United States

Location

Flavio Kruter, MD, PA

Westminster, Maryland, 21157, United States

Location

Minnesota Oncology Hematology, PA

Minneapolis, Minnesota, 55404, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

New Mexico Cancer Care Associates

Santa Fe, New Mexico, 87505, United States

Location

New York Oncology Hematology, PC

Albany, New York, 12208, United States

Location

Ruth Oratz MD

New York, New York, 10016, United States

Location

Raleigh Hematology Oncology Associates

Cary, North Carolina, 27511, United States

Location

Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States

Location

Willamette Vallejy Cancer Center

Eugene, Oregon, 97401, United States

Location

Medical Oncology Associates

Kingston, Pennsylvania, 18704, United States

Location

Texas Cancer Center - Abilene (South)

Abilene, Texas, 79606, United States

Location

Texas Oncology, P.A.-Amarillo

Amarillo, Texas, 79106, United States

Location

Texas Cancer Center

Arlington, Texas, 76014, United States

Location

Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702, United States

Location

Texas Oncology, PA-Bedford

Bedford, Texas, 76022, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230, United States

Location

Texas Oncology, PA

Dallas, Texas, 75231, United States

Location

The TexasCancer Center

Dallas, Texas, 75237, United States

Location

Texas Oncology, PA

Dallas, Texas, 75246, United States

Location

Texas Cancer Center-Denton

Denton, Texas, 76210, United States

Location

El Paso Cancer Treatment Ctr

El Paso, Texas, 79915, United States

Location

Texas Oncology, PA

Fort Worth, Texas, 76104, United States

Location

Texas Oncology, PA

Garland, Texas, 75042, United States

Location

Texas Oncology, PA

Houston, Texas, 77024, United States

Location

Lake Vista Cancer Center

Lewisville, Texas, 75067, United States

Location

Longview Cancer Center

Longview, Texas, 75601, United States

Location

South Texas Cancer Center-McAllen

McAllen, Texas, 78503, United States

Location

Texas Cancer Center of Mesquite

Mesquite, Texas, 75150, United States

Location

Alison Cancer Center

Midland, Texas, 79701, United States

Location

West Texas Cancer Center

Odessa, Texas, 79761, United States

Location

Paris Regional Cancer Center

Paris, Texas, 75460, United States

Location

HOAST-Medical Dr.

San Antonio, Texas, 78229, United States

Location

Texas Cancer Center-Sherman

Sherman, Texas, 75090, United States

Location

Texas Oncology Cancer Center-Sugar Land

Sugar Land, Texas, 77479, United States

Location

Tyler Cancer Center

Tyler, Texas, 75702, United States

Location

Texas Oncology Cancer Care and Research Center-Waco

Waco, Texas, 76712, United States

Location

Texas Oncology, P.A.

Webster, Texas, 77598, United States

Location

Fairfax Northern VA Hem-Onc PC

Fairfax, Virginia, 22031, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23502, United States

Location

Onc and Hem Associates of SW VA, Inc

Salem, Virginia, 24153, United States

Location

Puget Sound Cancer Center-Edmonds

Edmonds, Washington, 98026, United States

Location

Puget Sound Cancer Center-Seattle

Seattle, Washington, 98133, United States

Location

Cancer Care Northwest-North

Spokane, Washington, 99218, United States

Location

Northwest Cancer Specialists-Vancouver

Vancouver, Washington, 98684, United States

Location

Yakima Valley Mem Hosp/North Star Lodge

Yakima, Washington, 98902, United States

Location

Related Publications (1)

• 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.

  PMID: 22431702 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicin; Carboplatin; Trastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Dr. Rufus Collea
• Organization: New York Oncology Hematology, Albany Medical Center

rufus.collea@usoncology.com

518-262-6696

Study Officials

• Rufus P Collea, MD

  US Oncology Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2006
• First Posted: March 15, 2006
• Study Start: December 1, 2005
• Primary Completion: March 1, 2010
• Study Completion: June 1, 2011
• Last Updated: November 3, 2016
• Results First Posted: November 3, 2016

Record last verified: 2016-09

Locations

US (57)