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Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer

Phase 2
18 Years
Open (Enrolling)
Metastatic Breast Cancer

Thank you

Trial Information

Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer

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

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

- 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

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

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

- Is pregnant or lactating

- Is unable to comply with the requirements of the study

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Primary objective

Outcome Description:

To determine the objective response rates produced by irinotecan and carboplatin therapy with or without Erbitux

Outcome Time Frame:

Disease assessment

Safety Issue:


Principal Investigator

Joyce A. O'Shaughnessy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

US Oncology Research


United States: Institutional Review Board

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms



Texas Oncology, P.A. Dallas, Texas  75246
Virginia Oncology Associates Newport News, Virginia  23606
Comprehensive Cancer Centers of Nevada Las Vegas, Nevada  89109
Ocala Oncology Center Ocala, Florida  34474
Missouri Cancer Associates Columbia, Missouri  65201
Tyler Cancer Center Tyler, Texas  75702
Willamette Valley Cancer Center Eugene, Oregon  97401-8122
New York Oncology Hematology, P.C. Albany, New York  12208
Cancer Centers of Florida, P.A. Orlando, Florida  
Raleigh Hematology Oncology Clinic Cary, North Carolina  27511
Northwest Cancer Specialists-Vancouver Vancouver, Washington  98684
Florida Cancer Institute New Port Richey, Florida  34652
Minnesota Oncology Hematology, P.A. Minneapolis, Minnesota  55407
Texas Cancer Center at Medical City Dallas, Texas  75230
Allison Cancer Center Midland, Texas  79701
West Texas Cancer Center Odessa, Texas  79761
Greater Dayton Cancer Center Kettering, Ohio  45409
Birmingham Hematology and Oncology Birmingham, Alabama  35235
Cancer Center of the Carolinas, Seneca Seneca, South Carolina  29672
Texas Cancer Center Abilene, Texas  79606
Texas Oncology Cancer Center Austin, Texas  78731
Mamie McFaddin Ward Cancer Center Beaumont, Texas  77702
The Texas Cancer Center Dallas, Texas  75237
San Antonio Tumor & Blood Clinic Fredericksburg, Texas  78624
Longview Cancer Center Longview, Texas  75601
Texas Cancer Center of Mesquite Mesquite, Texas  75150
Onc and Hem Associates of SW VA, Inc. Salem, Virginia  24153
Central indiana Cancer Center Indianapolis, Indiana  46227
New York Oncology Hematology, PC Albany, New York  12208
Maryland Oncology Hematology, P.A. Columbia, Maryland  21044
Paris Regional Cancer Center Paris, Texas  75460
Waco Cancer Care and Research Center Waco, Texas  76712
Hematology Oncology Associates of IL Chicago, Illinois  60611
Rocky Mountain Cancer Center-Rose Denver, Colorado  80220
Northwestern Connecticut Oncology Hematology Associates New Milford, Connecticut  06776
Hematology Oncology Asscociates Phoenix, Arizona  85012
Northern AZ Hematology & Oncology Assoc Sedona, Arizona  86336
Melbourne Internal Medicine Associates Melbourne, Florida  32901
Kansas City Cancer-Southwest Overland Park, Kansas  66210
Arch Medical Services, Inc St. Louis, Missouri  63141
NH Oncology-Hematology PA Hooksett, New Hampshire  03106
Hematology-Oncology Associates of NNJ, P.A. Morristown, New Jersey  07960
Summit Medical Group Summit, New Jersey  07901
Interlakes Oncology Hematology, PC Rochester, New York  14623
Texas Cancer Center-Abilene(South) Abilene, Texas  79606
Texas Oncology, P.A. - Bedford Bedford, Texas  76022
Texas Oncology Center - Denton Denton, Texas  76210
El Paso Cancer Treatment Ctr El Paso, Texas  79915
South Texas Cancer Center-McAllen McAllen, Texas  78503
HOAST - New Braunfels New Braunfels, Texas  78131
Texas Cancer Center-Sherman Sherman, Texas  75090
Texas Oncology Cancer Center-Sugar Land Sugar Land, Texas  77479
Puget Sound Cancer Center-Emonds Edmonds, Washington  98026
Puget Sound Cancer Center-Seattle Seattle, Washington  98133
Cancer Care Northwest-South Spokane, Washington  99202
Yakima Valley Mem Hosp/North Star Lodge Yakima, Washington  98902