Re-challenge Therapy With Chemotherapy & Panitumumab in Metastatic Colorectal Cancer Patients Treated With an Anti-EGFR

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

patients with metastatic colorectal cancer who were initially RAS wild and failed at least 2 lines of chemotherapy will be enrolled. Anti-EGFR must have been given in 1st line. Those who remain RAS-wild upon retesting will receive rechallenge with panitumumab and chemotherapy

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Abdullah Medical City
• Treatments: Panitumumab

Criteria

Inclusion Criteria:

• Histologically confirmed metastatic adenocarcinoma of the colon or rectum with initially KRAS/RAS wild tumours.

• Patients received at least 2 lines of chemotherapy including a fluoropyrimidine, irinotecan and oxaliplatin± bevacizumab.

• First line chemotherapy regimen with a fluoropyrimidine and irinotecan or fluoropyrimidine and oxaliplatin in addition to an anti-EGFR agent (cetuximab/panitumumab).

• No evidence of disease progression for at least 4 months from the start of 1st line therapy.

• At least one measurable lesion ≥ 10 mm as assessed by CT-scan or MRI must be available and accessible for re-biopsy and RAS testing.

• Repeated RAS testing before re-challenge therapy must be done.

• Age ≥18 years.

• ECOG Performance status (PS) 0-2.

• The patient has adequate organ function, defined as : Absolute neutrophil count (ANC) ≥ 1.5 x 109/L, hemoglobin ≥ 9 g/dl, and platelets ≥ 100 x 109/L. Total bilirubin ≤ 1.5 times upper limit of normal value (ULN), serum alkaline phosphatase level < 5 times ULN, Serum creatinine level <1.5 mg/dl.

• For female patients of childbearing potential, negative pregnancy test within 7 days before starting the study treatment.

• Subject must provide informed consent prior to initiation of any study specific activities/procedures

Exclusion Criteria:

• Significant cardiovascular disease including unstable angina or myocardial infarction within 12 months before initiation of study treatment or a history of ventricular arrhythmia (treated or not).

• History or evidence of central nervous system metastasis (CT-scan or MRI are not mandatory if no clinical symptoms).

• Known allergy or hypersensitivity to panitumumab.

• Patients with right-sided colon cancer originating from the ascending colon or hepatic flexure.

• Patients with known MSI-high status.

• Patients with known HER2-positive status.

• Previous or concurrent malignancy except for basal or squamous cell skin cancer, in situ carcinoma of the cervix, low-risk prostate cancer according to d'Amico classification or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to the study.

• Active or uncontrolled clinically serious infection.

• Known human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS)-related illness.

• Other serious and uncontrolled non-malignant disease.

• Pregnancy.

• Breast feeding.

• Treatment with any other investigational medicinal product within 28 days prior to study entry.

• Concomitant administration of live, attenuated virus vaccine such as yellow fever vaccine.