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

NCT03940131 | Unknown Phase 2

• 1 other identifier: 19-504
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Metastatic Colorectal Cancer

Keywords

re-challenge; panitumumab

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR)

  defined as the proportion of patients with tumour response (complete response or partial response) by RECIST criteria 1.1.

  3 years

Secondary Outcomes (3)

• Disease control rate (DCR)

  3 years

• Progression-free survival (PFS)

  3 years

• Overall survival (OS)

  3 years

Study Arms (1)

Single Arm

EXPERIMENTAL

Panitumumab with FOLFOX6/FOLFIRI

Drug: Panitumumab

Interventions

Panitumumab DRUG

FOLFOX6 regimen consists of 2-hour infusion of oxaliplatin (85 mg/m2) and 2-hour infusion of leucovorin (400 mg/m2 ) on Day l, followed by 5-fluorouracil bolus (400 mg/m2) on Day 1 and 46-hour infusion (2.4 g/m2). FOLFOX6 regimen will be repeated at 2-week intervals. FOLFIRI regimen consists of 2-hour infusion of irinotecan (180 mg/m2) and 2-hour infusion of leucovorin (400 mg/m2 ) on Day l, followed by 5-fluorouracil bolus (400 mg/m2) on Day 1 and 46-hour infusion (2.4 g/m2). FOLFIRI regimen will be repeated at 2-week intervals.

Also known as: Folfox, Folfiri

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah Medical City: lead

Study Sites (1)

King Abdullah Medical City, Holy Capital

Mecca, Makkah Western, 21955, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Panitumumab; Folfox protocol; IFL protocol

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Shereef A Elsamany, MD

  King Abdullah Medical City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shereef A Elsamany, MD

CONTACT

+96625549999; shereefmohamad@yahoo.com

Rania M Felemban, MSc

CONTACT

+96625549999; raniafelemban@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single arm Phase II study

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 7, 2019
• Study Start: June 10, 2020
• Primary Completion: July 1, 2022
• Study Completion: July 1, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

SA (1)