An Exploratory Study of Treatment Sensitivity and Prognostic Factors in a Efficacy and Safety Study of mFOLFOX6 + Bevacizumab Versus mFOLFOX6 + Panitumumab Therapy in Patients With Chemotherapy-naïve Unresectable Advanced or Recurrent Colorectal Cancer

Takeda

Status and phase: Active, not recruiting; Phase 3

Conditions: Colorectal Cancer

Treatments: Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab; Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab

Study type: Observational

Funder types: Industry

Identifiers

NCT02394834

UMIN000016782 (Registry Identifier)

Panitumumab-4004

U1111-1167-3521 (Other Identifier)

jRCT1080222785 (Registry Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Full description

The drug being tested in this study is called Panitumumab. This exploratory study will investigate biomarkers which may be predictors of efficacy and safety of treatment with mFOLFOX6 + bevacizumab versus mFOLFOX6 + panitumumab therapy in patients with chemotherapy-naïve unresectable advanced or recurrent colorectal cancer.

Tumor tissue samples obtained from the participants who enrolled in the safety/efficacy study of Panitumumab + mFOLFOX versus bevacizumab + mFOLFOX (PARADIGM Study: NCT02394795) and provided consent for this additional study will be used. Mutations, amplification and rearrangement of predefined tumor-associated genes will be investigated using DNA collected from tumor samples used for assessing RAS mutations and plasma free DNA collected before administration of cycle 1 and at the discontinuation of the protocol treatment in the main study.

Enrollment: 757 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

(1) Patients who are enrolled in the main study and personally provided written consent after adequately explained about the contents of the additional study

Exclusion criteria

(1) Patients who are determined by the investigator or researchers to be not suitable for participating in the additional study

Trial design

757 participants in 2 patient groups

Group P; mFOLFOX6 + panitumumab combination therapy

Description:

OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 panitumumab: 6 mg/kg mFOLFOX6 + panitumumab combination therapy, once every two weeks

Treatment:

Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab

Group B; mFOLFOX6 + bevacizumab combination therapy

Description:

OXA: 85 mg/m2/day 1 l-LV: 200 mg/m2/day 1 5-FU iv: 400 mg/m2/day 1 5-FU civ: 2400 mg/m2/day 1-3 bevacizumab: 5 mg/kg/ mFOLFOX6 + bevacizumab combination therapy, once every two weeks

Treatment:

Drug: oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab