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Clinical Trials in the USA / NCT00248287
Active, not recruiting Phase 2

PhII ICb With/Without Erbitux in MBC Pts

NCT00248287 · tracked via the Priya Life Science USA tracker
Sponsor
US Oncology Research
Phase
Phase 2
Started
2005-07-28
Last updated
2025-01-29

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

Irinotecan + Carboplatinirinotecan + Carboplatin + erbitux

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

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

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (59)

FacilityCityRegionStatus
Birmingham Hematology and Oncology Birmingham Alabama
Hematology Oncology Asscociates Phoenix Arizona
Northern AZ Hematology & Oncology Assoc Sedona Arizona
Rocky Mountain Cancer Center-Rose Denver Colorado
Northwestern Connecticut Oncology Hematology Associates Torrington Connecticut
Melbourne Internal Medicine Associates Melbourne Florida
Florida Cancer Institute New Port Richey Florida
Ocala Oncology Center Ocala Florida
Cancer Centers of Florida, P.A. Ocoee Florida
Hematology Oncology Associates of IL Chicago Illinois
Central Indiana Cancer Center Indianapolis Indiana
Kansas City Cancer-Southwest Overland Park Kansas
Maryland Oncology Hematology, P.A. Columbia Maryland
Minnesota Oncology Hematology, P.A. Minneapolis Minnesota
Missouri Cancer Associates Columbia Missouri
Arch Medical Services, Inc St Louis Missouri
Comprehensive Cancer Centers of Nevada Las Vegas Nevada
NH Oncology-Hematology PA Hooksett New Hampshire
Hematology-Oncology Associates of NNJ, P.A. Morristown New Jersey
Summit Medical Group Summit New Jersey
New York Oncology Hematology, P.C. Albany New York
New York Oncology Hematology, PC Rexford New York
Interlakes Oncology Hematology, PC Rochester New York
Raleigh Hematology Oncology Clinic Cary North Carolina
Greater Dayton Cancer Center Kettering Ohio
Willamette Valley Cancer Center Eugene Oregon
Cancer Center of the Carolinas, Seneca Seneca South Carolina
Texas Cancer Center-Abilene(South) Abilene Texas
Texas Cancer Center Arlington Texas
Texas Oncology Cancer Center Austin Texas
Mamie McFaddin Ward Cancer Center Beaumont Texas
Texas Oncology, P.A. - Bedford Bedford Texas
Texas Cancer Center at Medical City Dallas Texas
Texas Oncology, P.A. Dallas Texas
The Texas Cancer Center Dallas Texas
Texas Oncology, P.A. Dallas Texas
Texas Oncology Center - Denton Denton Texas
El Paso Cancer Treatment Ctr El Paso Texas
Texas Oncology, P.A. Fort Worth Texas
San Antonio Tumor & Blood Clinic Fredericksburg Texas

+ 19 more sites — see the full list on the official registry below.

More US Oncology Research trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT00248287 on ClinicalTrials.gov ↗ ← All trials in the USA