PhII ICb With/Without Erbitux in MBC Pts (CA225200)
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|ClinicalTrials.gov Identifier: NCT00248287|
Recruitment Status : Active, not recruiting
First Posted : November 3, 2005
Results First Posted : November 3, 2016
Last Update Posted : October 25, 2018
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Randomized Phase II Study of Weekly Irinotecan/Carboplatin (ICb) With or Without Cetuximab (Erbitux) in Patients With Metastatic Breast Cancer|
|Actual Study Start Date :||July 28, 2005|
|Actual Primary Completion Date :||May 31, 2014|
|Estimated Study Completion Date :||December 31, 2019|
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
- 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.
- 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.
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT00248287
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|Principal Investigator:||Joyce A. O'Shaughnessy, MD||US Oncology Research|