MONARCC: A randomized phase II study of panitumumab monotherapy and panitumumab (pan) plus 5 Fluorouracil (FU) as first-line therapy for RAS and BRAF wild type metastatic colorectal cancer (mCRC): An AGITG clinical trial.

Authors

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Niall C. Tebbutt

Olivia Newton-John Cancer and Wellness Centre, Victoria, Australia

Niall C. Tebbutt , Christopher B. Steer , Katrin Marie Sjoquist , Lorraine A. Chantrill , Christos Stelios Karapetis , Louise M. Nott , David Espinoza , Martinus Oostendorp , Sonia Yip , Jeff Cuff , Matthew E. Burge

Organizations

Olivia Newton-John Cancer and Wellness Centre, Victoria, Australia, Border Medical Oncology, Albury Wodonga Regional Cancer Centre, Albury, NSW, Australia, NHMRC Clinical Trials Centre, The University of Sydney, Sydney, Australia, Macarthur Cancer Therapy Centre, The Kinghorn Cancer Centre and University of Western Sydney, Sydney, Australia, Flinders Medical Centre, Flinders University, Adelaide, Australia, Royal Hobart Hospital, Hobart, Australia, NHMRC Clinical Trials Centre, University of Sydney, Sydney, Australia, Sydney Catalyst Translational Cancer Research Centre, Sydney, Australia, Australasian Gastro-Intestinal Trials Group–Consumer Advisory Panel, Sydney, Australia, Royal Brisbane and Women's Hospital, Brisbane, Australia

Research Funding

Pharmaceutical/Biotech Company
AMGEN, Other Foundation

Background: Pan added to combination chemotherapy is established first-line therapy for RAS and BRAF wild type mCRC. Elderly patients are not well represented in clinical trials and may be more suited to treatment protocols with lower toxicity risks; FU plus bevacizumab (bev) is commonly used. Treatment related efficacy, toxicity, impact on quality of life and other outcomes of pan based regimens in an elderly population have not been well studied. Methods: A prospective non-comparative randomized phase 2 study. Australian Clinical Trials Registry Number: ACTRN 12618000233224. Main inclusion criteria include: Untreated patients aged 70 years or older; RAS and BRAF wild type; ECOG performance 0-2. Randomisation 1:1, stratified by primary tumour side, performance status, number of metastatic sites; to pan 6mg/kg 2 weekly or panitumumab plus FU 400 mg/m² bolus; leucovorin 200mg/m²; FU 2400mg/m² 48 hour infusion 2 weekly. Primary endpoint is 6-month progression-free survival (PFS). Sample size is 80 patients based on expected 6-month PFS rate of 73% with FU and bev. Using the method of Metha-Cain, if 24 or more patients are progression free at 6 months, the one sided 95% confidence interval includes 73% and we declare similar activity. Secondary endpoints include overall survival; toxicity and overall treatment utility, a composite measure of treatment benefit based on radiology, clinical progress, toxicity and patient reflection of the impact of treatment on their daily lives. Patients undergo a comprehensive health assessment at baseline and limited health assessment at 4 months. Physical activity trackers are worn for 2 weeks at treatment commencement and again at week 16. Tumour tissue and blood samples (at baseline, cycle 3 day 1 and at 24 weeks) will be collected for translational research. First site opened in June 2018. Twelve patients have been recruited to date from 9 sites in Australasia. Eighteen sites were open as at September 2019. Clinical trial information: 12618000233224.

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Abstract Details

Meeting

2020 Gastrointestinal Cancers Symposium

Session Type

Trials in Progress Poster Session

Session Title

Trials in Progress Poster Session C: Anal and Colorectal Cancer

Track

Colorectal Cancer,Anal Cancer

Sub Track

Therapeutics

Clinical Trial Registration Number

12618000233224

Citation

J Clin Oncol 38, 2020 (suppl 4; abstr TPS271)

Abstract #

TPS271

Poster Bd #

N5

Abstract Disclosures