Clinical Trial Details

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.

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Trial Information

Broad Health Condition Cancer

Specific Health ConditionBowel - Back passage (rectum) or large bowel (colon)

Trial FocusTreatment

Recruitment statusRecruiting

Recruitment Details
Recruitment State
NSW,QLD,SA,TAS,WA,VIC

Hospital
Austin Health - Austin Hospital - Heidelberg
Border Medical Oncology - Albury
Coffs Harbour Base Hospital - Coffs Harbour
Flinders Medical Centre - Bedford Park
The Queen Elizabeth Hospital - Woodville
Royal Hobart Hospital - Hobart
Monash Medical Centre - Clayton campus - Clayton
The Tweed Hospital - Tweed Heads
Royal Brisbane & Womens Hospital - Herston
St Vincent's Hospital (Darlinghurst) - Darlinghurst
Sunshine Coast University Hospital - Birtinya
Gold Coast University Hospital - Southport
The Prince Charles Hospital - Chermside
Northern Cancer Institute - St Leonards
Nepean Hospital - Kingswood
Princess Alexandra Hospital - Woolloongabba
Sunshine Hospital - St Albans
Shoalhaven Hospital - Nowra


Postcode
3084 - Heidelberg
3690 - Wodonga
2450 - Coffs Harbour
5042 - Bedford Park
5011 - Woodville
7000 - Hobart
3168 - Clayton
2485 - Tweed Heads
4029 - Herston
2010 - Darlinghurst
4575 - Birtinya
4215 - Southport
4032 - Chermside
2065 - St Leonards
2747 - Kingswood
4102 - Woolloongabba
3021 - St Albans
2541 - Nowra

Anticipated date of first participant enrolment30/03/2018

Anticipated date of last participant enrolment30/03/2018

Phase of TrialPhase 2

Has the study received ethics approval?Further information iconApproved

Trial summary

This trial (MONARCC) seeks to determine what the best initial treatment is for a patient population with metastatic colorectal cancer that cannot withstand the expected side effects of the commonly used combination chemotherapy regimens.

Who is it for?
You may be eligible to join this study if you are aged 70 years or above and have a confirmed diagnosis of untreated metastatic colorectal cancer.

Study details
Participants in this study will be randomly (by chance) allocated to one of two groups. Participants in one group will receive low intensity targeted therapy, panitumumab, which is generally well tolerated as a single treatment without chemotherapy. Participants in the other group will receive panitumumab combined with chemotherapy (5FU), a standard treatment. All treatments are administered via the intravenous route (i.e. directly into the vein) and will be administered every 2 weeks until disease progression or unacceptable toxicity.

All participants will be followed up to 18 months in order to assess treatment efficacy and safety. The hypothesis is that panitumumab will be a safe, acceptable, effective and convenient regimen to elderly patients with newly diagnosed advanced colorectal cancer.
Eligibility

Key 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. Measurable metastatic disease (by RECIST 1.1)
5. RAS (KRAS exons 2,3 and 4; NRAS exons 2 and 3) wild type as assessed by the investigator’s choice of testing laboratory.
6. BRAF wild type as assessed by the investigator’s choice of testing laboratory. Patients with BRAF V600E mutations are not eligible. Patient with non-V600E BRAF mutations (if tested for) are eligible.
7. No prior chemotherapy except for adjuvant chemotherapy given in association with (i) complete resection of primary colon or rectal cancer provided there is no clinical, radiological or biochemical evidence of relapse for at least 6 months after completion of adjuvant treatment and/or (ii) complete resection of limited colorectal metastases to liver and/or lung provided there is no clinical, radiological or biochemical evidence of relapse for at least 6 months after completion of adjuvant treatment
8. Prior palliative radiotherapy is allowed, provided no concurrent chemotherapy was administered, at least 2 weeks after completion of therapy has elapsed before enrolment, and any toxicities have resolved to grade 1 or less.
a) Prior fluoropyrimidine chemotherapy, concurrent with radiation as neoadjuvant treatment for rectal cancer is allowed.
b) Prior radiotherapy, concurrent with radiation sensitizing fluoropyrimidines in the setting of metastatic disease is allowed.
9. Adequate haematological function: ANC > 1500/µl, Platelets >75,000/µl, Haemoglobin > 8g/dl. INR and APTT <1.5 x ULN. Note: patients previously on long term anticoagulation with warfarin or low molecular weight heparin are eligible.
10. Adequate liver function: Albumin > 25 g/l. Total bilirubin <3 x ULN. AST, ALT and/or alkaline phosphatase (ALP) <5 x ULN.
11. Adequate renal function, creatinine clearance, as measured by the Cockcroft and Gault formula) of >30mls/minute. 
12. Serum potassium, magnesium and total calcium < grade 2 above or below the institution’s normal limits. Note: total calcium should be corrected for albumin level as per the institution’s usual calculation method.
13. ECOG performance status 0-2.
14. Patient is being treated with non-curative intent. This may be because the disease is anatomically not resectable or that resection is contra-indicated for any reason or the patient refuses resection.
15. Archival tissue for central review of RAF/BRAF mutation status.
16. Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments.
17. Signed, written informed consent.

Minimum age70 Years

GenderBoth males and females

Can Healthy volunteers participate?No

Key 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. Leptomeningeal disease as the only manifestation of their malignancy.
6. Known clinically significant dihydropyrimidine dehydrogenase deficiency.
7. History of interstitial lung disease or pulmonary fibrosis.
8. Untreated/active CNS metastases ie progressing, requiring ongoing corticosteroids or anticonvulsants for symptom control. Patients with CNS metastases are eligible if previously have been successfully treated with surgery and/or radiotherapy at least 8 weeks prior to cycle 1 day 1, are off all corticosteroids and/or anticonvulsants for at least 4 weeks and imaging within 4 weeks of cycle 1 day 1 excludes any progression.
9. Any other reason the investigator feels will prevent the patient from complying with the protocol specified treatments and assessments.
10. Invasive malignancy, other than CRC, diagnosed within 2 years of randomisation and that the investigator feels may have an impact on the patient’s outcome or disease assessments. Patients with prior or concurrent in-situ cervix carcinoma, skin SCC or basal cell carcinoma are eligible.
11. Other comorbidities or conditions that may compromise assessment of key outcomes
12. Life expectancy of less than 3 months.
13. Concurrent illness, including severe infection that may jeopardise the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety.
14. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
Contact details and further information

Sponsor Primary Sponsor Type: Other Collaborative groups
Primary Sponsor Name: AGITG
Primary Sponsor Address: Level 6, 119–143 Missenden Road, Camperdown NSW 2050
Primary Sponsor Country: Australia

Trial IDACTRN12618000233224

Contact person for information and recruitmentMs
MONARCC Trial Coordinator
NHMRC Clinical Trials Centre, University of Sydney 119–143 Missenden Road, Camperdown NSW 2050
+61 2 9562 5000.

Further information iconmonarcc@ctc.usyd.edu.au
Australia