PhII ICb With/Without Erbitux in MBC Pts

NCT ID: NCT00248287

Last Updated: 2025-01-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 154 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-28
• Study Completion Date: 2026-12-31

Brief Summary

The purpose of this study is to determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux in patients with Metastatic Breast Cancer.

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm 1

irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle (Arm 1, ICb)

Group Type: ACTIVE_COMPARATOR

Irinotecan + Carboplatin

Intervention Type: DRUG

irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle

Arm 2

irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2 Week 1 and then 250 mg/m2 weekly thereafter, (Arm 2, ICb+Erbitux)

Group Type: EXPERIMENTAL

irinotecan + Carboplatin + erbitux

Intervention Type: DRUG

irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2

Interventions

Irinotecan + Carboplatin

irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle

Intervention Type: DRUG

irinotecan + Carboplatin + erbitux

irinotecan 90mg/m2, carboplatin AUC=2.0 on Days 1 and 8 of each 21- day cycle plus Erbitux 400 mg/m2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

Male and female patients will be eligible for inclusion in this study if they meet all of the following criteria:

• Has cytologically or pathologically confirmed, breast cancer with documented HER2+ (positive) (3+ by IHC or FISH+) or HER2- (negative) disease. ER, PR, and HER2 status must be documented in the electronic Case Report Form (eCRF) NOTE: Patients whose breast cancers are HER2 (2+) by IHC must undergo FISH testing to confirm HER2+ (positive) status.
• Has clinically confirmed Stage IV metastatic breast cancer (MBC)
• Has undergone prior Herceptin therapy if breast cancer is HER2+ (positive)
• Has measurable MBC as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria

NOTE: Ascites, pleural effusion, and bone metastases are not considered measurable.

• Has had up to 1 prior chemotherapy regimens for metastatic disease. Previously untreated disease is permitted.
• Has had no prior treatment with irinotecan, carboplatin, or cisplatin
• Has an ECOG Performance Status (PS) 0-2
• Is greater than 18 years of age
• Please see protocol for specific details regarding appropriate laboratory values for inclusion to the study.
• Any prior radiation therapy has been completed > 2 weeks prior to the start of study treatment

NOTE: Previously irradiated lesions will not be evaluable; however, these patients will still be eligible. Patients must have at least 1 measurable lesion at baseline.

• Has had a negative serum pregnancy test within 7 days prior to registration (female patients of childbearing potential). A pregnancy test is also required within 7 days of Dose 1.
• If fertile, patient (male or female) has agreed to use an acceptable method of birth control to avoid pregnancy for the duration of the study and for a period of 6 months thereafter.
• Has signed a Patient Informed Consent Form
• Has signed a Patient Authorization Form (HIPAA)
• Has paraffin-embedded breast cancer tissue (either paraffin blocks or 20 unstained slides) available for analysis of EGFR, cytokeratin, and other biological markers. These samples will be sent to the Molecular Profiling Institute (MPI; see Appendix VII).

NOTE: Availability of samples should be confirmed prior to randomization (at latest, prior to first dose).

Exclusion Criteria

• Has Stage I-III breast cancer or nonmeasurable metastatic breast cancer, or any disease other than that described in inclusion criterion #1
• Has received prior treatment with irinotecan, carboplatin, or cisplatin
• Is receiving any concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s)
• Has received prior therapy which specifically and directly targets the EGFR pathway. Prior Herceptin is required for HER2+ patients.
• Has had prior severe infusion reaction to a monoclonal antibody
• Has received organ allograft(s) other than corneal, bone, or skin
• Has clinically significant uncontrolled cardiac disease (eg, congestive heart failure, symptomatic coronary artery disease or cardiac arrhythmias not well-controlled with medication) or has had a myocardial infarction < 12 months
• Has ongoing peripheral neuropathy > Grade I
• Has evidence of symptomatic or untreated central nervous system (CNS) metastases (unless CNS metastases have been irradiated). Chronic steroid treatment for the treatment of CNS metastases must have been discontinued for greater than 4 weeks prior to study enrollment.
• Has any other significant comorbidity that, in the opinion of the clinical investigator, might compromise any aspect of the study
• Has active or uncontrolled infection
• Has acute hepatitis or is known to be HIV positive
• Has a history of other malignancy within the last 5 years which could affect the diagnosis or assessment of MBC, with the exception of carcinoma of the cervix in situ, carcinoma of the bladder in situ, and basal cell carcinoma
• Has previously completed a chemotherapy regimen within 3 weeks prior to the start of study treatment, or has related toxicities unresolved prior to the start of study treatment

NOTE: If patient was receiving prior weekly or daily chemotherapy, he/she may begin study therapy 2 weeks after stopping prior therapy provided all toxicities have resolved; peripheral neuropathy must be less than Grade I as per exclusion criterion #8 above.

• Has had major surgery within 3 weeks from the start of study treatment, without complete recovery
• Has participated in any investigational drug study within 4 weeks preceding the start of study treatment
• Has received a concurrent immunotherapy or hormonal anticancer agent within 2 weeks prior to the start of the study treatment
• Is receiving a tyrosine kinase inhibitor (ie, IressaTM)
• Has had any prior stem cell or bone marrow transplant for any prior hematologic malignancy
• Is pregnant or lactating
• Is unable to comply with the requirements of the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Pfizer

INDUSTRY

Sponsor Role: collaborator

US Oncology Research

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joyce A. O'Shaughnessy, MD

Role: PRINCIPAL_INVESTIGATOR

US Oncology Research

Locations

Birmingham Hematology and Oncology

Birmingham, Alabama, United States

Hematology Oncology Asscociates

Phoenix, Arizona, United States

Northern AZ Hematology & Oncology Assoc

Sedona, Arizona, United States

Rocky Mountain Cancer Center-Rose

Denver, Colorado, United States

Northwestern Connecticut Oncology Hematology Associates

Torrington, Connecticut, United States

Melbourne Internal Medicine Associates

Melbourne, Florida, United States

Florida Cancer Institute

New Port Richey, Florida, United States

Ocala Oncology Center

Ocala, Florida, United States

Cancer Centers of Florida, P.A.

Ocoee, Florida, United States

Hematology Oncology Associates of IL

Chicago, Illinois, United States

Central Indiana Cancer Center

Indianapolis, Indiana, United States

Kansas City Cancer-Southwest

Overland Park, Kansas, United States

Maryland Oncology Hematology, P.A.

Columbia, Maryland, United States

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, United States

Missouri Cancer Associates

Columbia, Missouri, United States

Arch Medical Services, Inc

St Louis, Missouri, United States

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

NH Oncology-Hematology PA

Hooksett, New Hampshire, United States

Hematology-Oncology Associates of NNJ, P.A.

Morristown, New Jersey, United States

Summit Medical Group

Summit, New Jersey, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

New York Oncology Hematology, PC

Rexford, New York, United States

Interlakes Oncology Hematology, PC

Rochester, New York, United States

Raleigh Hematology Oncology Clinic

Cary, North Carolina, United States

Greater Dayton Cancer Center

Kettering, Ohio, United States

Willamette Valley Cancer Center

Eugene, Oregon, United States

Cancer Center of the Carolinas, Seneca

Seneca, South Carolina, United States

Texas Cancer Center-Abilene(South)

Abilene, Texas, United States

Texas Cancer Center

Arlington, Texas, United States

Texas Oncology Cancer Center

Austin, Texas, United States

Mamie McFaddin Ward Cancer Center

Beaumont, Texas, United States

Texas Oncology, P.A. - Bedford

Bedford, Texas, United States

Texas Cancer Center at Medical City

Dallas, Texas, United States

Texas Oncology, P.A.

Dallas, Texas, United States

The Texas Cancer Center

Dallas, Texas, United States

Texas Oncology, P.A.

Dallas, Texas, United States

Texas Oncology Center - Denton

Denton, Texas, United States

El Paso Cancer Treatment Ctr

El Paso, Texas, United States

Texas Oncology, P.A.

Fort Worth, Texas, United States

San Antonio Tumor & Blood Clinic

Fredericksburg, Texas, United States

Texas Oncology, P.A.

Houston, 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

Allison Cancer Center

Midland, Texas, United States

HOAST - New Braunfels

New Braunfels, Texas, United States

West Texas Cancer Center

Odessa, Texas, United States

Paris Regional Cancer Center

Paris, 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

Waco Cancer Care and Research Center

Waco, Texas, 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-Emonds

Edmonds, Washington, United States

Puget Sound Cancer Center-Seattle

Seattle, Washington, United States

Cancer Care Northwest-South

Spokane, Washington, United States

Northwest Cancer Specialists-Vancouver

Vancouver, Washington, United States

Yakima Valley Mem Hosp/North Star Lodge

Yakima, Washington, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CA225200

Identifier Type: OTHER

Identifier Source: secondary_id

04070

Identifier Type: -

Identifier Source: org_study_id