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 : Not yet recruiting
First Posted : May 7, 2019
Last Update Posted : October 3, 2019
|Condition or disease||Intervention/treatment||Phase|
|Metastatic Colorectal Cancer||Drug: Panitumumab||Phase 2|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Single arm Phase II study|
|Masking:||None (Open Label)|
|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.|
|Estimated Study Start Date :||December 2019|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03940131
|Contact: Shereef A Elsamany, MD||+96625549999 ext firstname.lastname@example.org|
|Contact: Rania M Felemban, MSc||+96625549999 ext email@example.com|