PhII ICb With/Without Erbitux in MBC Pts

Metastatic Breast Cancer Clinical Trial

— CA225200  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00248287
• Other study ID #: 04070
• Secondary ID: CA225200
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 28, 2005
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: US Oncology Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 154
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Texas Cancer Center-Abilene(South)	Abilene	Texas
United States	New York Oncology Hematology, P.C.	Albany	New York
United States	Texas Cancer Center	Arlington	Texas
United States	Texas Oncology Cancer Center	Austin	Texas
United States	Mamie McFaddin Ward Cancer Center	Beaumont	Texas
United States	Texas Oncology, P.A. - Bedford	Bedford	Texas
United States	Birmingham Hematology and Oncology	Birmingham	Alabama
United States	Raleigh Hematology Oncology Clinic	Cary	North Carolina
United States	Hematology Oncology Associates of IL	Chicago	Illinois
United States	Maryland Oncology Hematology, P.A.	Columbia	Maryland
United States	Missouri Cancer Associates	Columbia	Missouri
United States	Texas Cancer Center at Medical City	Dallas	Texas
United States	Texas Oncology, P.A.	Dallas	Texas
United States	Texas Oncology, P.A.	Dallas	Texas
United States	The Texas Cancer Center	Dallas	Texas
United States	Texas Oncology Center - Denton	Denton	Texas
United States	Rocky Mountain Cancer Center-Rose	Denver	Colorado
United States	Puget Sound Cancer Center-Emonds	Edmonds	Washington
United States	El Paso Cancer Treatment Ctr	El Paso	Texas
United States	Willamette Valley Cancer Center	Eugene	Oregon
United States	Texas Oncology, P.A.	Fort Worth	Texas
United States	San Antonio Tumor & Blood Clinic	Fredericksburg	Texas
United States	NH Oncology-Hematology PA	Hooksett	New Hampshire
United States	Texas Oncology, P.A.	Houston	Texas
United States	Central Indiana Cancer Center	Indianapolis	Indiana
United States	Greater Dayton Cancer Center	Kettering	Ohio
United States	Comprehensive Cancer Centers of Nevada	Las Vegas	Nevada
United States	Longview Cancer Center	Longview	Texas
United States	South Texas Cancer Center-McAllen	McAllen	Texas
United States	Melbourne Internal Medicine Associates	Melbourne	Florida
United States	Texas Cancer Center of Mesquite	Mesquite	Texas
United States	Allison Cancer Center	Midland	Texas
United States	Minnesota Oncology Hematology, P.A.	Minneapolis	Minnesota
United States	Hematology-Oncology Associates of NNJ, P.A.	Morristown	New Jersey
United States	HOAST - New Braunfels	New Braunfels	Texas
United States	Florida Cancer Institute	New Port Richey	Florida
United States	Virginia Oncology Associates	Norfolk	Virginia
United States	Ocala Oncology Center	Ocala	Florida
United States	Cancer Centers of Florida, P.A.	Ocoee	Florida
United States	West Texas Cancer Center	Odessa	Texas
United States	Kansas City Cancer-Southwest	Overland Park	Kansas
United States	Paris Regional Cancer Center	Paris	Texas
United States	Hematology Oncology Asscociates	Phoenix	Arizona
United States	New York Oncology Hematology, PC	Rexford	New York
United States	Interlakes Oncology Hematology, PC	Rochester	New York
United States	Arch Medical Services, Inc	Saint Louis	Missouri
United States	Onc and Hem Associates of SW VA, Inc.	Salem	Virginia
United States	Puget Sound Cancer Center-Seattle	Seattle	Washington
United States	Northern AZ Hematology & Oncology Assoc	Sedona	Arizona
United States	Cancer Center of the Carolinas, Seneca	Seneca	South Carolina
United States	Texas Cancer Center-Sherman	Sherman	Texas
United States	Cancer Care Northwest-South	Spokane	Washington
United States	Texas Oncology Cancer Center-Sugar Land	Sugar Land	Texas
United States	Summit Medical Group	Summit	New Jersey
United States	Northwestern Connecticut Oncology Hematology Associates	Torrington	Connecticut
United States	Tyler Cancer Center	Tyler	Texas
United States	Northwest Cancer Specialists-Vancouver	Vancouver	Washington
United States	Waco Cancer Care and Research Center	Waco	Texas
United States	Yakima Valley Mem Hosp/North Star Lodge	Yakima	Washington

Sponsors (3)

Lead Sponsor	Collaborator
US Oncology Research	Bristol-Myers Squibb, Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of Response	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.	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.
Secondary	Median Time of Progression-free Survival (PFS)	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.	2 years
Secondary	Median Overall Survival (OS)	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.	2 years