A phase II randomized study comparing the efficacy and safety of mFOLFOX6 + panitumumab combination therapy and 5-FU/LV + panitumumab combination therapy in the patients with chemotherapy-naive unresectable advanced recurrent colorectal carcinoma of KRAS wild-type after 6 cycles of combination therapy with mFOLFOX6 + panitumumab

TAKEDA PHARMACEUTICAL COMPANY LTD.0 sites164 target enrollmentSeptember 30, 2014

Overview

No summary available.

Registry

who.int

Start Date

September 30, 2014

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Sponsor

•Inclusion criteria for enrollment:
•(1\) Patients with unresectable adenocarcinoma originating in the large intestine (excluding carcinoma of the appendix and anal canal cancer)
•(2\) Patients with measurable lesion(s) according to the RECIST ver. 1\.1
•(3\) Patients who have not received chemotherapy for colorectal cancer. Patients who experience relapse more than 6 months after the final dose of perioperative adjuvant chemotherapy with fluoropyrimidine agents may be enrolled.
•(4\) Aged\>\= 20 years at the time of informed consent
•(5\) Patients classified as KRAS wild\-type. However, the criteria will be changed to all patients who are verified to be of KRAS and NRAS wild\-type when the KRAS and NRAS tests come to be covered by National Health Insurance, and the tests become feasible at medical institutions.
•(6\) Patients who satisfy the following criteria for the major organ function in tests performed within 14 days prior to enrollment
•1\) Neutrophil count \>\= 1\.5 x 103/microL
•2\) White blood cell count \>\= 3\.0 x 103/microL
•3\) Platelet count \>\= 10\.0 x 104/microL

•Exclusion criteria for enrollment:
•(1\) Radiotherapy received for a measurable lesion
•(2\) Radiotherapy received within 28 days (4 weeks) prior to enrollment for a lesion other than measurable lesions
•(3\) Known brain metastasis or strongly suspected of brain metastasis
•(4\) Synchronous cancers or metachronous cancers with a disease\-free period of \<\- 5 years (excluding colorectal cancer) excluding mucosal cancers cured or be possibly cured by regional resection (esophageal, stomach, and cervical cancer, non\-melanoma skin cancer, bladder cancer, etc.).
•(5\) Body cavity fluid that requires treatment (pleural effusion, ascites, pericardial effusion, etc.)
•(6\) Patients who do not want to use contraception to prevent pregnancy, and women who are pregnant or breast\-feeding, or test positive for pregnancy
•(7\) Active hemorrhage requiring blood transfusion
•(8\) Disease requiring systemic steroids for treatment (excluding topical steroids)
•(9\) Intestinal resection and colostomy within 14 days (2 weeks) prior to enrollment