Panitumumab and Chemotherapy in Patients With Advanced Colorectal Cancer After Prior Therapy With Bevacizumab
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|ClinicalTrials.gov Identifier: NCT01814501|
Recruitment Status : Recruiting
First Posted : March 20, 2013
Last Update Posted : February 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Mucinous Adenocarcinoma of the Colon Mucinous Adenocarcinoma of the Rectum Recurrent Colon Cancer Recurrent Rectal Cancer Signet Ring Adenocarcinoma of the Colon Signet Ring Adenocarcinoma of the Rectum Stage IV Colon Cancer Stage IV Rectal Cancer||Biological: panitumumab Drug: irinotecan hydrochloride Drug: fluorouracil Drug: leucovorin calcium||Phase 2|
I. To determine the median progression-free survival in patients treated with leucovorin calcium, fluorouracil, and irinotecan hydrochloride (FOLFIRI) and panitumumab for K-ras and NRAS wild-type, metastatic colorectal carcinoma who have already progressed on FOLFIRI + Bevacizumab.
I. To determine the frequency and severity of toxicities of the regimens. II. To determine overall response rate. III. To determine the median overall survival and the overall survival rate at 1 year.
Patients receive panitumumab intravenously (IV) over 60-90 minutes, leucovorin calcium IV over 90 minutes, fluorouracil IV continuously over 46 hours, and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Panitumumab in Combination With FOLFIRI After Progression on FOLFIRI Plus Bevacizumab in KRAS(Kirsten Rat Sarcoma) and NRAS Wild-Type Metastatic Colorectal Cancer.|
|Actual Study Start Date :||February 2013|
|Estimated Primary Completion Date :||December 31, 2018|
|Estimated Study Completion Date :||December 31, 2018|
Experimental: Treatment (panitumumab, combination chemotherapy)
5-Fluorouracil, irinotecan, and panitumumab
Drug: irinotecan hydrochloride
Drug: leucovorin calcium
- Progression free survival(PFS) [ Time Frame: Time from study day 1 to the time the patient is first recorded as having disease progression or death, assessed up to 2 years ]Continuous variables will be expressed by means, standard deviations and 95% confidence intervals. Estimated using the Kaplan-Meier estimator with confidence interval calculated based on the Brookmeyer-Crowley method.
- Frequency and severity of toxicities of the regimens, graded according to the NCI CTCAE v4.0 [ Time Frame: Up to 2 years ]Frequencies will be computed for discrete data.
- Overall response rate, as described in RECIST v1.1 criteria [ Time Frame: Up to 2 years ]
- Overall survival [ Time Frame: Time from study day 1 to the date of death or the last date the patient was known to be alive, assessed up to 1 year ]Continuous variables will be expressed by means, standard deviations and 95% confidence intervals. Kaplan-Meier estimator will be used.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814501
|Contact: Ohio State University Comprehensive Cancer Center||1-800-293-5066||OSUCCCClinicaltrials@osumc.edu|
|Contact: Hamida Umar||614-685-6406||Hamida.Umar@osumc.edu|
|United States, Ohio|
|Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: John Hays, MD 614-293-6529 John.Hays@osumc.edu|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Emily Chan, MD 615-322-4967 Emily.Chan@vanderbilt.edu|
|Principal Investigator:||John Hays, MD||Ohio State University Comprehensive Cancer Center|