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

  • Clinicaltrials.gov identifier

    NCT03940131

  • Recruitment Status

    Recruiting

  • First Posted

    May 7, 2019

  • Last update posted

    September 11, 2020

Study Description

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

  • Condition or Disease:Metastatic Colorectal Cancer
  • Intervention/Treatment: Drug: Panitumumab
  • Phase: Phase 2

Detailed Description

This is a single arm pilot multicenter prospective study. We will recruit KRAS/RAS wild metastatic colorectal cancer patients who received at least 2 lines of chemotherapy and the 1st line must include cetuximab/panitumumab combined with chemotherapy. We will repeat RAS testing after progression on the last line of therapy. RAS testing will be taken via liquid biopsy using ctDNA or tissue biopsy from either a new tumour lesion or a previously present lesion which shows evidence of disease progression by radiological imaging. Only RAS-wild patients upon re-testing will be enrolled and will receive re-challenge therapy with panitumumab combined with chemotherapy similar to that given at 1st line (5-fluorouracil/leucoverin combined with oxaliplatin or irinotecan). Those converted to RAS mutant will not be enrolled. All patients will be treated until disease progression, unacceptable toxic effects or withdrawal of consent.

Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 30 participants
  • Intervention Model: Single Group Assignment
  • Intervention Model Description: Single arm Phase II study
  • Masking: None (Open Label) ()
  • Primary Purpose: Treatment
  • Official Title: Re-challenge Therapy With Chemotherapy and Panitumumab in Metastatic Colorectal Cancer Patients Treated With an Anti-EGFR Therapy in 1st Line Treatment: a Phase II Multicentre Study.
  • Actual Study Start Date: June 2020
  • Estimated Primary Completion Date: July 2022
  • Estimated Study Completion Date: July 2022

Arms and interventions

Arm Intervention/treatment
Experimental: Single Arm
Panitumumab with FOLFOX6/FOLFIRI
Drug: Panitumumab
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.

Outcome Measures

  • Primary Outcome Measures: 1. Overall response rate (ORR) [ Time Frame: 3 years ]
    defined as the proportion of patients with tumour response (complete response or partial response) by RECIST criteria 1.1.
  • Secondary Outcome Measures: 1. Disease control rate (DCR) [ Time Frame: 3 years ]
    defined as the proportion of patients with tumour response (complete response or partial response) or tumour stabilization during study treatment.
  • 2. Progression-free survival (PFS) [ Time Frame: 3 years ]
    defined as the time from the date of starting the study treatment regimen till the date of the first disease progression after re-challenge therapy or death (any cause).
  • 3. Overall survival (OS) [ Time Frame: 3 years ]
    defined as the time from the date of starting the study treatment regimen to the date of patient death, due to any cause, or to the last date at which the patient was known to be alive.

Eligibility Criteria

  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

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.

Contacts and Locations

Contacts

Contact: Shereef A Elsamany, MD +96625549999 ext 13721 shereefmohamad@yahoo.com

Contact: Rania M Felemban, MSc +96625549999 ext 18013 raniafelemban@gmail.com

Locations

Saudi Arabia, Makkah Western
King Abdullah Medical City, Holy Capital
Mecca

Sponsors and Collaborators

King Abdullah Medical City

Investigators

Principal Investigator: Shereef A Elsamany, MD King Abdullah Medical City

More Information

  • Responsible Party: King Abdullah Medical City
  • ClinicalTrials.gov Identifier: NCT03940131 History of Changes
  • Other Study ID Numbers: 19-504
  • First Posted: May 7, 2019 Key Record Dates
  • Last Update Posted: September 11, 2020
  • Last Verified: September 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by King Abdullah Medical City: re-challenge panitumumab
  • Additional relevant MeSH terms: Colorectal Neoplasms