PhII ICb With/Without Erbitux in MBC Pts

NCT00248287 | Active Not Recruiting Phase 2 Results

• 2 other identifiers: 04070CA225200
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 59

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

Outcome Measures

Primary Outcomes (1)

• Objective Response Rates (ORR)

  To determine the objective response rates (CR + PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.

  2 years

Secondary Outcomes (3)

• Duration of Response

  From date of randomization until the date of first documented progression or the date of death from any cause, whichever came first, assessed up to 60 months.

• Median Time of Progression-free Survival (PFS)

  2 years

• Median Overall Survival (OS)

  2 years

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

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

Drug: Irinotecan + Carboplatin

Arm 2

EXPERIMENTAL

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)

Drug: irinotecan + Carboplatin + erbitux

Interventions

Irinotecan + Carboplatin DRUG

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

Arm 1

irinotecan + Carboplatin + erbitux DRUG

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

Arm 2

Eligibility Criteria

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

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• US Oncology Research: lead
• Bristol-Myers Squibb: collaborator
• Pfizer: collaborator

Study Sites (59)

Birmingham Hematology and Oncology

Birmingham, Alabama, 35205, United States

Location

Hematology Oncology Asscociates

Phoenix, Arizona, 85012, United States

Location

Northern AZ Hematology & Oncology Assoc

Sedona, Arizona, 86336, United States

Location

Rocky Mountain Cancer Center-Rose

Denver, Colorado, 80220, United States

Location

Northwestern Connecticut Oncology Hematology Associates

Torrington, Connecticut, 06790, United States

Location

Melbourne Internal Medicine Associates

Melbourne, Florida, 32901, United States

Location

Florida Cancer Institute

New Port Richey, Florida, 34655, United States

Location

Ocala Oncology Center

Ocala, Florida, 34474, United States

Location

Cancer Centers of Florida, P.A.

Ocoee, Florida, 34761, United States

Location

Hematology Oncology Associates of IL

Chicago, Illinois, 60611, United States

Location

Central Indiana Cancer Center

Indianapolis, Indiana, 46227, United States

Location

Kansas City Cancer-Southwest

Overland Park, Kansas, 66210, United States

Location

Maryland Oncology Hematology, P.A.

Columbia, Maryland, 21044, United States

Location

Minnesota Oncology Hematology, P.A.

Minneapolis, Minnesota, 55404, United States

Location

Missouri Cancer Associates

Columbia, Missouri, 65201, United States

Location

Arch Medical Services, Inc

St Louis, Missouri, 63141, United States

Location

Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, 89109, United States

Location

NH Oncology-Hematology PA

Hooksett, New Hampshire, 03106, United States

Location

Hematology-Oncology Associates of NNJ, P.A.

Morristown, New Jersey, 07960, United States

Location

Summit Medical Group

Summit, New Jersey, 07901, United States

Location

New York Oncology Hematology, P.C.

Albany, New York, 12208, United States

Location

New York Oncology Hematology, PC

Rexford, New York, 12148, United States

Location

Interlakes Oncology Hematology, PC

Rochester, New York, 14623, United States

Location

Raleigh Hematology Oncology Clinic

Cary, North Carolina, 27511, United States

Location

Greater Dayton Cancer Center

Kettering, Ohio, 45409, United States

Location

Willamette Valley Cancer Center

Eugene, Oregon, 97401, United States

Location

Cancer Center of the Carolinas, Seneca

Seneca, South Carolina, 29672, United States

Location

Texas Cancer Center-Abilene(South)

Abilene, Texas, 79606, United States

Location

Texas Cancer Center

Arlington, Texas, 76014, United States

Location

Texas Oncology Cancer Center

Austin, Texas, 78731, United States

Location

Mamie McFaddin Ward Cancer Center

Beaumont, Texas, 77702, United States

Location

Texas Oncology, P.A. - Bedford

Bedford, Texas, 76022, United States

Location

Texas Cancer Center at Medical City

Dallas, Texas, 75230, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75231, United States

Location

The Texas Cancer Center

Dallas, Texas, 75237, United States

Location

Texas Oncology, P.A.

Dallas, Texas, 75246, United States

Location

Texas Oncology Center - Denton

Denton, Texas, 76210, United States

Location

El Paso Cancer Treatment Ctr

El Paso, Texas, 79915, United States

Location

Texas Oncology, P.A.

Fort Worth, Texas, 76104, United States

Location

San Antonio Tumor & Blood Clinic

Fredericksburg, Texas, 78624, United States

Location

Texas Oncology, P.A.

Houston, Texas, 77024, 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

Allison Cancer Center

Midland, Texas, 79701, United States

Location

HOAST - New Braunfels

New Braunfels, Texas, 78131, United States

Location

West Texas Cancer Center

Odessa, Texas, 79761, United States

Location

Paris Regional Cancer Center

Paris, Texas, 75460, 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

Waco Cancer Care and Research Center

Waco, Texas, 76712, United States

Location

Virginia Oncology Associates

Norfolk, Virginia, 23505, United States

Location

Onc and Hem Associates of SW VA, Inc.

Salem, Virginia, 24153, United States

Location

Puget Sound Cancer Center-Emonds

Edmonds, Washington, 98026, United States

Location

Puget Sound Cancer Center-Seattle

Seattle, Washington, 98133, United States

Location

Cancer Care Northwest-South

Spokane, Washington, 99202, 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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Irinotecan; Carboplatin; Cetuximab

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Camptothecin; Alkaloids; Heterocyclic Compounds; 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. Joyce O'Shaughnessy
• Organization: Baylor Sammons Cancer Center

Joyce.OShaughnessy@usoncology.com

(214) 370 -1796

Study Officials

• Joyce A. O'Shaughnessy, 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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2005
• First Posted: November 3, 2005
• Study Start: July 28, 2005
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 29, 2025
• Results First Posted: November 3, 2016

Record last verified: 2025-01

Locations

US (59)