PhII ICb With/Without Erbitux in MBC Pts

Running, not enrolling · Phase 2

Conditions studied: Metastatic Breast Cancer

In brief

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.

Key facts

Study ID: NCT00248287
Run by: US Oncology Research
People needed: 154
Starts: 2005-07-28
Expected to finish: 2026-12-01
Last updated by the study team: 2025-01-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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).

You may not qualify if…

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

Where it is running

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
Birmingham Hematology and Oncology — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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