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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer

Thank you

Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Primary Objective

Outcome Description:

To determine the ORR associated with Doxil in combination with carboplatin in HER2- (negative) MBC (and with Herceptin in HER2+ MBC)

Safety Issue:

No

Principal Investigator

Rufus P Collea, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research

Authority:

United States: Food and Drug Administration

Study ID:

04111

NCT ID:

NCT00303108

Start Date:

December 2005

Completion Date:

March 2010

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

Name

Location

Texas Oncology, P.A.Dallas, Texas  75246
Virginia Oncology AssociatesNewport News, Virginia  23606
Comprehensive Cancer Centers of NevadaLas Vegas, Nevada  89109
Ocala Oncology CenterOcala, Florida  34474
Missouri Cancer AssociatesColumbia, Missouri  65201
New Mexico Cancer Care AssociatesSanta Fe, New Mexico  87505-7670
Tyler Cancer CenterTyler, Texas  75702
Texas Oncology, PADallas, Texas  75246-2006
Northwest Cancer Specialists-VancouverVancouver, Washington  98684
Medical Oncology AssociatesKingston, Pennsylvania  18704
Florida Cancer InstituteNew Port Richey, Florida  34652
Central Indiana Cancer CentersIndianapolis, Indiana  46227
Texas Cancer Center at Medical CityDallas, Texas  75230
West Texas Cancer CenterOdessa, Texas  79761
Hematology Oncology AssociatesPhoenix, Arizona  85012
Greater Dayton Cancer CenterKettering, Ohio  45409
Birmingham Hematology and OncologyBirmingham, Alabama  35235
Texas Cancer CenterAbilene, Texas  79606
Mamie McFaddin Ward Cancer CenterBeaumont, Texas  77702
Lake Vista Cancer CenterLewisville, Texas  75067
Longview Cancer CenterLongview, Texas  75601
Texas Cancer Center of MesquiteMesquite, Texas  75150
Cancer Care Northwest-NorthSpokane, Washington  99218
Raleigh Hematology Oncology AssociatesCary, North Carolina  27511
Minnesota Oncology Hematology, PAMinneapolis, Minnesota  55404
New York Oncology Hematology, PCAlbany, New York  12208
Paris Regional Cancer CenterParis, Texas  75460
Hematology Oncology Associates of ILChicago, Illinois  60611
Maryland Oncology Hematology, PAColumbia, Maryland  21044
Rocky Mountain Cancer Center-RoseDenver, Colorado  80220
El Paso Cancer Treatment CtrEl Paso, Texas  79915
South Texas Cancer Center-McAllenMcAllen, Texas  78503
Texas Cancer Center-ShermanSherman, Texas  75090
Texas Oncology Cancer Center-Sugar LandSugar Land, Texas  77479
Puget Sound Cancer Center-SeattleSeattle, Washington  98133
Yakima Valley Mem Hosp/North Star LodgeYakima, Washington  98902
Fairfax Northern VA Hem-Onc PCFairfax, Virginia  22031
Puget Sound Cancer Center-EdmondsEdmonds, Washington  98026
Kansas City Cancer Centers-SouthwestOverland Park, Kansas  66210
Texas Cancer Center-DentonDenton, Texas  76210
Northern AZ Hematology & Oncology Associates-SedonaSedona, Arizona  86336
Cancer Care & Hematology Specialists of Chicagoland, PCNiles, Illinois  60714
Flavio Kruter, MD, PAWestminster, Maryland  21157
Ruth Oratz MDNew York, New York  10016
Willamette Vallejy Cancer CenterEugene, Oregon  97401
Texas Cancer Center - Abilene (South)Abilene, Texas  79606
Texas Oncology, P.A.-AmarilloAmarillo, Texas  79106
Texas Oncology, PA-BedfordBedford, Texas  76022
The TexasCancer CenterDallas, Texas  75237
Alison Cancer CenterMidland, Texas  79701
HOAST-Medical Dr.San Antonio, Texas  78229
Texas Oncology Cancer Care and Research Center-WacoWaco, Texas  76712
Onc and Hem Associates of SW VA, IncSalem, Virginia  24153