Description:
National multicentric phase II trial evaluating whether single agent cetuximab is effective
as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients
with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after
start of maintenance therapy.
Title
- Brief Title: Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)
- Official Title: Randomized Phase II Study of First-line FOLFIRI Plus Cetuximab for 8 Cycles Followed by Either Single-agent Cetuximab as Maintenance Therapy or Observation in Patients With Wild-type KRAS and NRAS Metastatic Colorectal Cancer
Clinical Trial IDs
- ORG STUDY ID:
Prodige 28 - UCGI 27 (TIME)
- SECONDARY ID:
2012-005139-99
- NCT ID:
NCT02404935
Conditions
- Metastatic Colorectal Cancer
Interventions
Drug | Synonyms | Arms |
---|
Cetuximab | | Arm A cetuximab |
FOLFIRI and cetuximab | | Arm A cetuximab |
Purpose
National multicentric phase II trial evaluating whether single agent cetuximab is effective
as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab in mCRC patients
with KRAS and NRAS wild-type genes, assessed by progression-free survival at 6 months after
start of maintenance therapy.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm A cetuximab | Experimental | cetuximab 500 mg/m2 (every 2 weeks) until progression | - Cetuximab
- FOLFIRI and cetuximab
|
Arm B observation | Other | observation until progression | |
Eligibility Criteria
Inclusion Criteria:
1. Histologically confirmed colorectal cancer
2. KRAS and NRAS wild-type genes after analysis of mutation status from the primary
tumour or metastasis
3. Non resectable metastatic disease in a curative intent
4. No prior chemotherapy except for fluoropyrimidines with or without oxaliplatin-based
adjuvant treatment, at least 6 months before inclusion
5. At least one measurable tumour target (higher than 20 mm) according to RECIST
criteria, which has never been irradiated
6. Life expectancy above 3 months
7. Performance Status ≤2 (WHO)
8. Patient ≥18 years-old
9. Acceptable blood test
10. Patient having signed a written informed consent form
Exclusion Criteria:
1. Known and/or symptomatic brain metastases
2. Known allergy to one of treatment components
3. Neurological or psychiatric condition which could interfere with good treatment
compliance
4. Current anti-tumour treatment : chemotherapy or targeted therapy or radiotherapy ≤ 14
days before randomisation
5. Other severe conditions such as: respiratory failure. History of interstitial lung
disease e.g. pneumonitis or pulmonary fibrosis or evidence of interstitial lung
disease on baseline chest CT scan
6. Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) 6 months before enrollment/randomization
7. Concomitant severe infection
8. History of cancer (except skin cancer other than melanoma or an in situ cervical
epithelioma or other solid tumour treated for curative purposes without signs of the
condition and with no treatment administered in the 5 years before randomisation.)
9. Patient already included in another clinical trial with an investigational molecule
10. Prior treatment with anti-EGFr antibodies (e.g. panitumumab (Vectibix® or cetuximab /
Erbitux® ) or treatment with small EGFr inhibitor molecules (e.g., erlotinib /
Tarceva®)
11. Pregnant female, likely to be or currently breastfeeding, or planning to become
pregnant within 6 months after the end of treatment or absence of effective
contraception for males and females of childbearing age during treatment and for 6
months (male or female) after the end of treatment
12. Those deprived of their freedom or under guardianship
13. Impossibility of undergoing trial's medical follow-up for geographical, social or
psychological reasons
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Progression Free Survival at 6 months |
Time Frame: | 6 months after start of maintenance therapy |
Safety Issue: | |
Description: | Endpoints will include Progression assessed by CT Scan according to RECIST 1.1 criteria and Death from any cause |
Details
Phase: | Phase 2 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | UNICANCER |
Trial Keywords
- Metastatic colorectal cancer
- cetuximab
- maintenance
Last Updated
November 4, 2020