PhII ICb With/Without Erbitux in MBC Pts (CA225200)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00248287
Recruitment Status : Active, not recruiting
First Posted : November 3, 2005
Results First Posted : November 3, 2016
Last Update Posted : November 3, 2016
Bristol-Myers Squibb
Information provided by (Responsible Party):
US Oncology Research

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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: Irinotecan + Carboplatin Drug: irinotecan + Carboplatin + erbitux Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer
Study Start Date : July 2005
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Arm 1
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
irinotecan 90 mg/m2 and carboplatin AUC=2.0 on Days 1 and 8 of each 21-day cycle
Experimental: 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)
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

Primary Outcome Measures :
  1. Objective Response Rates (ORR) [ Time Frame: 2 years ]
    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.

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: 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. ]

    The duration of response is measured from the time measurement criteria are first met for CR/PR until the first date that recurrent or progressive disease is objectively documented.

    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. Median Time of Progression-free Survival (PFS) [ Time Frame: 2 years ]
    PFS is measured from the date of randomization to the date of first documented disease progression or date of death, whichever comes first. If a patient neither progresses nor dies, this patient will be censored at last contact date.

  3. Median Overall Survival (OS) [ Time Frame: 2 years ]
    OS is measured from the date of randomization to the date of death for a dead patient. If a patient is still alive or is lost to follow up, the patient will be censored at the last contact date.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


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).


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00248287

  Hide Study Locations
United States, Alabama
Birmingham Hematology and Oncology
Birmingham, Alabama, United States, 35205
United States, Arizona
Hematology Oncology Asscociates
Phoenix, Arizona, United States, 85012
Northern AZ Hematology & Oncology Assoc
Sedona, Arizona, United States, 86336
United States, Colorado
Rocky Mountain Cancer Center-Rose
Denver, Colorado, United States, 80220
United States, Connecticut
Northwestern Connecticut Oncology Hematology Associates
Torrington, Connecticut, United States, 06790
United States, Florida
Melbourne Internal Medicine Associates
Melbourne, Florida, United States, 32901
Florida Cancer Institute
New Port Richey, Florida, United States, 34655
Ocala Oncology Center
Ocala, Florida, United States, 34474
Cancer Centers of Florida, P.A.
Ocoee, Florida, United States, 34761
United States, Illinois
Hematology Oncology Associates of IL
Chicago, Illinois, United States, 60611
United States, Indiana
Central Indiana Cancer Center
Indianapolis, Indiana, United States, 46227
United States, Kansas
Kansas City Cancer-Southwest
Overland Park, Kansas, United States, 66210
United States, Maryland
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
United States, Minnesota
Minnesota Oncology Hematology, P.A.
Minneapolis, Minnesota, United States, 55404
United States, Missouri
Missouri Cancer Associates
Columbia, Missouri, United States, 65201
Arch Medical Services, Inc
St. Louis, Missouri, United States, 63141
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
NH Oncology-Hematology PA
Hooksett, New Hampshire, United States, 03106
United States, New Jersey
Hematology-Oncology Associates of NNJ, P.A.
Morristown, New Jersey, United States, 07960
Summit Medical Group
Summit, New Jersey, United States, 07901
United States, New York
New York Oncology Hematology, P.C.
Albany, New York, United States, 12208
New York Oncology Hematology, PC
Rexford, New York, United States, 12148
Interlakes Oncology Hematology, PC
Rochester, New York, United States, 14623
United States, North Carolina
Raleigh Hematology Oncology Clinic
Cary, North Carolina, United States, 27511
United States, Ohio
Greater Dayton Cancer Center
Kettering, Ohio, United States, 45409
United States, Oregon
Willamette Valley Cancer Center
Eugene, Oregon, United States, 97401
United States, South Carolina
Cancer Center of the Carolinas, Seneca
Seneca, South Carolina, United States, 29672
United States, Texas
Texas Cancer Center-Abilene(South)
Abilene, Texas, United States, 79606
Texas Cancer Center
Arlington, Texas, United States, 76014
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Mamie McFaddin Ward Cancer Center
Beaumont, Texas, United States, 77702
Texas Oncology, P.A. - Bedford
Bedford, Texas, United States, 76022
Texas Cancer Center at Medical City
Dallas, Texas, United States, 75230
Texas Oncology, P.A.
Dallas, Texas, United States, 75231
The Texas Cancer Center
Dallas, Texas, United States, 75237
Texas Oncology, P.A.
Dallas, Texas, United States, 75246
Texas Oncology Center - Denton
Denton, Texas, United States, 76210
El Paso Cancer Treatment Ctr
El Paso, Texas, United States, 79915
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
San Antonio Tumor & Blood Clinic
Fredericksburg, Texas, United States, 78624
Texas Oncology, P.A.
Houston, Texas, United States, 77024
Longview Cancer Center
Longview, Texas, United States, 75601
South Texas Cancer Center-McAllen
McAllen, Texas, United States, 78503
Texas Cancer Center of Mesquite
Mesquite, Texas, United States, 75150
Allison Cancer Center
Midland, Texas, United States, 79701
HOAST - New Braunfels
New Braunfels, Texas, United States, 78131
West Texas Cancer Center
Odessa, Texas, United States, 79761
Paris Regional Cancer Center
Paris, Texas, United States, 75460
Texas Cancer Center-Sherman
Sherman, Texas, United States, 75090
Texas Oncology Cancer Center-Sugar Land
Sugar Land, Texas, United States, 77479
Tyler Cancer Center
Tyler, Texas, United States, 75702
Waco Cancer Care and Research Center
Waco, Texas, United States, 76712
United States, Virginia
Virginia Oncology Associates
Norfolk, Virginia, United States, 23505
Onc and Hem Associates of SW VA, Inc.
Salem, Virginia, United States, 24153
United States, Washington
Puget Sound Cancer Center-Emonds
Edmonds, Washington, United States, 98026
Puget Sound Cancer Center-Seattle
Seattle, Washington, United States, 98133
Cancer Care Northwest-South
Spokane, Washington, United States, 99202
Northwest Cancer Specialists-Vancouver
Vancouver, Washington, United States, 98684
Yakima Valley Mem Hosp/North Star Lodge
Yakima, Washington, United States, 98902
Sponsors and Collaborators
US Oncology Research
Bristol-Myers Squibb
Principal Investigator: Joyce A. O'Shaughnessy, MD US Oncology Research

Responsible Party: US Oncology Research Identifier: NCT00248287     History of Changes
Other Study ID Numbers: 04070
CA225200 ( Other Identifier: Bristol-Myers-Squibb )
First Posted: November 3, 2005    Key Record Dates
Results First Posted: November 3, 2016
Last Update Posted: November 3, 2016
Last Verified: September 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action