Clinical Trials /

Treatment After Irinotecan-based Frontline Therapy: Maintenance With Erbitux (in Patients wtRAS mCRC)

NCT02404935

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.

Related Conditions:
  • Colorectal Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

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

DrugSynonymsArms
CetuximabArm A cetuximab
FOLFIRI and cetuximabArm 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

NameTypeDescriptionInterventions
Arm A cetuximabExperimentalcetuximab 500 mg/m2 (every 2 weeks) until progression
  • Cetuximab
  • FOLFIRI and cetuximab
Arm B observationOtherobservation until progression
  • FOLFIRI and cetuximab

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 earlier than 6 months ago from inclusion date

          5. Patient presenting with at least one measurable tumour target (greater than 20 mm)
             according to RECIST criteria, which has never been irradiated

          6. Patient with a greater than 3 month life expectancy

          7. Performance Status less or equal to 2

          8. Male or female 18 years or older

          9. Acceptable blood test

         10. Patient who has 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. Patient currently in treatment with any other anti-tumour therapy: chemotherapy or
             targeted therapy or radiotherapy ≤ 14 days before randomisation

          5. Other serious 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 enrolment/randomisation

          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 breast feeding, 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:Evaluate whether single agent cetuximab is effective as maintenance therapy after 8 cycles of first line FOLFIRI plus cetuximab (Progression Free Survival)
Time Frame:6 months after start of maintenance therapy
Safety Issue:
Description:Progression Free Survival (PFS) at 6 months after start of maintenance therapy defined as the number of patients at 6 months from the date of randomization without documented progression or death from any cause. Progression will be assessed by CT scan according to RECIST criteria version 1.1

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:UNICANCER

Trial Keywords

  • Metastatic colorectal cancer
  • cetuximab
  • maintenance

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