MONARCC

Protocol Title

A randomised phase 2 study of panitumumab monotherapy and panitumumab plus 5 fluorouracil as first line therapy for RAS and BRAF wild type metastatic colorectal cancer

Purpose of the Study

The aim of this study is to investigate the activity of anti-EGFR monotherapy, or combined with infusional 5FU, in a molecularly selected, elderly patient population with metastatic colorectal cancer.

Eligibility Criteria

Inclusion Criteria

1. Adults aged 70years and over.
2. Histologically or cytologically confirmed, previously untreated, metastatic colorectal cancer
3. Suitable for panitumumab or panitumumab plus infusional 5FU, as deemed by the investigator.
4. No prior chemotherapy.
5. Prior palliative radiotherapy is allowed, provided no concurrent chemotherapy was administered.
6. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
7. Signed, written informed consent.

Exclusion Criteria

1. Contraindications to investigational product.
2. Any prior treatment with cetuximab or panitumumab or bevacizumab.
3. Concurrent toxicity from any prior agent has not resolved to grade 1 or less.
4. Any major surgical procedure within two weeks of cycle 1 day 1.
5. History of interstitial lung disease or pulmonary fibrosis.
6. Any other reason the investigator feels will prevent the patient from complying with the protocol specified treatments and assessments.
7. Life expectancy of less than 3 months.
8. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
9. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol

Contact Email

monarcc@ctc.usyd.edu.au

Study Chair

Dr Matthew Burge

DETAILED INFORMATION AVAILABLE

Available online at the Australian New Zealand Clinical Trial Registry (ANZCTR) Please click here

Funding

2016 Innovation Fund Grant