FOLFIRI and Panitumumab in Treating Patients With RAS and BRAF Wild-Type Metastatic Colorectal Cancer
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|ClinicalTrials.gov Identifier: NCT02508077|
Recruitment Status : Terminated (Poor Accrual)
First Posted : July 24, 2015
Results First Posted : August 16, 2018
Last Update Posted : August 16, 2018
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Colorectal Carcinoma Stage IVA Colorectal Cancer Stage IVB Colorectal Cancer||Drug: Fluorouracil Drug: Irinotecan Hydrochloride Other: Laboratory Biomarker Analysis Drug: Leucovorin Calcium Biological: Panitumumab||Phase 2|
I. Estimate the response rate (RR) and progression-free survival (PFS) with FOLFIRI + panitumumab in patients with acquired resistance to panitumumab (or cetuximab) + irinotecan (irinotecan hydrochloride)-based therapy after a documented clinical response or prolonged PFS and following progression on a subsequent non-anti-EGFR containing regimen in extended RAS wild-type and BRAF wild-type patients.
I. Estimate the overall survival (OS) in the re-challenge populations.
II. Describe the safety of re-challenge in this population.
III. Investigate the impact of PFS, RR on prior anti-EGFR + irinotecan-based exposure on the response and PFS on the current study.
I. Collect serial plasma samples to investigate the incidence of RAS and BRAF mutation in circulating free deoxyribonucleic acid (DNA) at baseline, every 2 months, and at the time to progression (and following progression when feasible).
II. Collect serial plasma samples for future biomarker exploration, including the potential investigation of micro-ribonucleic acid (RNA).
Patients receive panitumumab intravenously (IV) over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium orally (PO), and fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then every 3 months thereafter.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Study of FOLFIRI Plus Panitumumab in Extended RAS Wild Type and BRAF Wild Type Metastatic Colorectal Cancer With Acquired Resistance to Prior Cetuximab (or Panitumumab) Plus Irinotecan-Based Therapy and Who Failed at Least One Subsequent Non-anti-EGFR Containing Regimen|
|Actual Study Start Date :||February 16, 2016|
|Actual Primary Completion Date :||September 13, 2017|
|Actual Study Completion Date :||September 13, 2017|
Experimental: Treatment (panitumumab and FOLFIRI)
Patients receive panitumumab IV over 30-90 minutes, irinotecan hydrochloride IV over 90 minutes, leucovorin calcium PO, and fluorouracil IV over 46 hours on day 1. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.
Drug: Irinotecan Hydrochloride
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
- 4-month Progression-free Survival (PFS) Rate [ Time Frame: At 4 months ]PFS is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first. Will be estimated using the product-limit method of Kaplan and Meier. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum on study (including baseline sum), or a measurable increase in a non-target lesion, or the appearance of new lesions.
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): NCT02508077
|United States, California|
|City of Hope Medical Center|
|Duarte, California, United States, 91010|
|City of Hope Antelope Valley|
|Lancaster, California, United States, 93534|
|City of Hope Rancho Cucamonga|
|Rancho Cucamonga, California, United States, 91730|
|South Pasadena Cancer Center|
|South Pasadena, California, United States, 91030|
|Principal Investigator:||Marwan Fakih||City of Hope Comprehensive Cancer Center|