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

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

TwoPhase Two

70+Age Over 70

Bowel<br/>CancersCancer LocationBowel
Cancers

Systemic therapy | Bowel (colorectum)Colon,Colorectum,Rectum

Trial Overview Read MoreRead more

This phase II trial is trying to determine whether it is better to give a targeted therapy (Panitumumab) alone or in combination with standard chemotherapy (5-FU) as a primary treatment for advanced colorectal cancer.
 

This trial is treating patients with RAS and BRAF-wild type colorectal cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • You have been diagnosed with cancer, but have not received any treatment.
  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

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

Commercial Sponsor

AMGEN

Summary

The primary endpoint for this trial is rate of progression free survival at 6 months, as defined by RECIST V1.1. Participants will be randomly assigned to one of two groups. In the intervention group, participants will receive targeted therapy (intravenous Panitumumab 6mg/Kg)alone, every two weeks, until disease progression or unacceptable toxicity. In the control group, participants will receive Panitumumab plus standard chemotherapy (5-fluorouracil / 5-FU) every two weeks until disease progression or toxicity. The chemotherapy schedule will consist of 5FU bolus 400mg/m2; leucovorin 200mg/m2; 5FU 46 hour infusion at 2400mg/m2.

Recruiting Hospitals Read MoreRead more

Monash Health, Medical Oncology
Clayton
Ms Karen Gillett
Karen.Gillett@monashhealth.org
(03) 8572 2018

Western Health - Sunshine Hospital
St Albans
Ms Heike Raunow
Heike.Raunow@wh.org.au
03 8395 9167

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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