A multicenter, phase II trial to investigate the safety and efficacy of Panitumumab and Irinotecan in Neo Ras Wild type metastatic colorectal cancer patients - C-PROWESS study

Shinozaki Eiji0 sites30 target enrollmentJanuary 20, 2022

Overview

No summary available.

Registry

who.int

Start Date

January 20, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

Shinozaki Eiji

•Patients eligible for inclusion in this study have to meet all of the following criteria:
•1\) Must give written Informed Consent
•2\) Histologically proven diagnosis of colorectal adenocarcinoma
•3\) Advanced or recurrent colorectal cancer (excluding appendix and anal canal cancer)
•4\) Age\>\= 20 years
•5\) Eastern Cooperative Oncology Group (ECOG) performance status \<\= 2
•6\) At least one measurable lesion according to RECIST version 1\.1 criteria evaluated by CT or MRI within 28 days before registration
•7\) RAS mutation (MT) (KRAS/NRAS exon 2, 3, or 4 MT) confirmed by tumor histology prior to the study enrollment
•8\) Must have had documentation of the RAS WT confirmed within 28 days from test result date by ctDNA analysis using the OncoBEAM (TM) RAS CRC KIT
•9\) Must have confirmed refractory or intolerant to previous treatments with chemotherapies including fluoropyrimidines, oxaliplatin, or irinotecan (irinotecan is applied to refractory only), regardless of prior treatment with trifluridine tipiracil hydrochloride, regorafenib, or angiogenesis inhibitors.

•Patients eligible for inclusion in this study must not meet any of the following criteria:
•1\) Evidence of BRAF V600E MT by tumor histology.
•2\) Treated with blood transfusion, blood products, or hematopoietic factor products such as Granulocyte Colony Stimulating Factor within 7 days prior to enrollment in this study.
•3\) Have a history of severe drug hypersensitivity or severe drug allergy
•4\) Active infection (fever of 38 degree or higher due to infection).
•5\) Ascites, pleural effusion, or pericardial effusion requiring continuous drainage.
•6\) Uncontrolled diabetes mellitus.
•7\) Uncontrolled hypertension.
•8\) Patients who have been treated with any of the following treatments prior to starting study drug:
•a.Extensive surgery \<\= 4 weeks prior to starting study drug (e.g., surgical treatment with organ resection, excluding colostomy)