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

Phase 2

• Conditions: Colorectal carcinoma

• Registration Number: JPRN-jRCT1080222617
• Lead Sponsor: TAKEDA PHARMACEUTICAL COMPANY LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-09-30
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 164

Inclusion Criteria

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
4) Hemoglobin >= 9.0 g/dL
5) Total bilirubin >= 2.0 mg/dL
6) AST >= 100 U/L (<= 200 U/L if liver metastases are present)
7) ALT >= 100 U/L (<= 200 U/L if liver metastases are present)
8) Serum creatinine <= 1.5 mg/dL
(7) Patients who are assessed at Eastern Cooperative Oncology Group (ECOG) performance status (P.S.) of 0 or 1
(8) Life expectancy of >= 6 months after enrollment
(9) Patients who have given written consent to take part in the study after detailed explanation of the study prior to enrollment

Inclusion criteria for randomization:
(1) Patients who have received 6 cycles of mFOLFOX6 + panitumumab combination therapy
(2) Patients who are assessed at ECOG P.S. of 0-1 in the 6th cycle.
(3) Patients for whom PD or not evaluable has been denied on the RECIST based on imaging tests conducted after the day of administration in the 6th cycle within 14 days (2 weeks).

Exclusion Criteria

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
(10) History or obvious and extensive computerized tomography findings of interstitial pulmonary disease (interstitial pneumonia, pulmonary fibrosis, etc.)
(11) Serious drug hypersensitivity
(12) Local or systemic active infection requiring treatment, or fever indicating infection
(13) Intestinal paralysis, gastrointestinal obstruction, or uncontrollable diarrhea (incapacitating symptoms despite adequate treatment)
(14) Active hepatitis B and/or active hepatitis C
(15) Known human immunodeficiency virus infection
(16) Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study

Exclusion criteria for randomization:
(1) Patients in whom interstitial pneumonia has been newly diagnosed during the period from registration to randomization
(2) Patients who have received radiotherapy during the period from registration to randomization
(3) Other patients judged by the investigator or subinvestigator to be ineligible for enrollment in the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified