- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03940131
Re-challenge Therapy With Chemotherapy & Panitumumab in Metastatic Colorectal Cancer Patients Treated With an Anti-EGFR (REPAN)
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Contact
- Name: Shereef A Elsamany, MD
- Phone Number: 13721 +96625549999
- Email: shereefmohamad@yahoo.com
Study Contact Backup
- Name: Rania M Felemban, MSc
- Phone Number: 18013 +96625549999
- Email: raniafelemban@gmail.com
Study Locations
-
-
Makkah Western
-
Mecca, Makkah Western, Saudi Arabia, 21955
- Recruiting
- King Abdullah Medical City, Holy Capital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Single Arm
Panitumumab with FOLFOX6/FOLFIRI
|
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:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 years
|
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 years
|
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.
|
3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shereef A Elsamany, MD, King Abdullah Medical City
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-504
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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