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

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ClinicalTrials.gov Identifier: NCT03940131
Recruitment Status : Recruiting
First Posted : May 7, 2019
Last Update Posted : September 11, 2020
Sponsor:
Information provided by (Responsible Party):
King Abdullah Medical City

Tracking Information
First Submitted Date  ICMJE May 5, 2019
First Posted Date  ICMJE May 7, 2019
Last Update Posted Date September 11, 2020
Actual Study Start Date  ICMJE June 10, 2020
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2019)
  • 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.
  • 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).
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Re-challenge Therapy With Chemotherapy & Panitumumab in Metastatic Colorectal Cancer Patients Treated With an Anti-EGFR
Official Title  ICMJE 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.
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
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Single arm Phase II study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Metastatic Colorectal Cancer
Intervention  ICMJE 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.
Other Names:
  • Folfox
  • Folfiri
Study Arms  ICMJE Experimental: Single Arm
Panitumumab with FOLFOX6/FOLFIRI
Intervention: Drug: Panitumumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date July 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Shereef A Elsamany, MD +96625549999 ext 13721 shereefmohamad@yahoo.com
Contact: Rania M Felemban, MSc +96625549999 ext 18013 raniafelemban@gmail.com
Listed Location Countries  ICMJE Saudi Arabia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03940131
Other Study ID Numbers  ICMJE 19-504
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party King Abdullah Medical City
Study Sponsor  ICMJE King Abdullah Medical City
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shereef A Elsamany, MD King Abdullah Medical City
PRS Account King Abdullah Medical City
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP