Clinical Trial: FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to Prevent Acneiforme Follicular Exanthema

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Non-randomized Phase-IV-study to Investigate the Efficacy of FOLFIRI in Combination With Cetuximab in the First-line Treatment of Metastatic Colorectal Cancer Including a Regular Dermal Prophylaxis to

Brief Summary:

The purpose of this interventional study is to assess the progression free survival (one year) of patients with treatment of FOLFIRI and cetuximab, combined with an optional dermal prophylaxis.

Further Objectives:

  1. Development of acneiforme follicular exanthema >= grade 2
  2. Duration until development of acneiforme follicular exanthema >= grade 2
  3. Development of paronychia
  4. Development skin fissure (hand and foot)
  5. Objective remission according RECIST 1.1
  6. Rate of secondary resections of liver metastasis with a curative approach
  7. Assessment of safety and tolerability
  8. Overall survival
  9. Progression free survival

Detailed Summary:

Subjects with metastatic colorectal cancer and confirmed KRAS-wildtype status in 1st line therapy will be included in this phase IV-study. Subject will receive a regimen of FOLFIRI in combination with Cetuximab every two weeks during study treatment phase. Treatment continues until

  • disease progression
  • complete response
  • development of status of operability
  • an uncontrollable exanthema grade 3 or 4 or
  • intolerable toxicity is diagnosed. After study discontinuation or end of treatment, respectively, patients will be followed up until the the last patient was treated for 12 months and has completed the 36-months follow up phase. Tumor response will be evaluated (according to RECIST 1.1) every 12 weeks and at the end of study treatment

Sponsor: Dr. Carl Schimanski

Current Primary Outcome: Progression-free survival [ Time Frame: 12 months ]

Progression-free survival rate at 12 months


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Progression-free survival [ Time Frame: up to end of follow-up-phase (36 months) ]
  • ORR [ Time Frame: approximately 12 months ]
    Objective response rate over the entire treatment period
  • OS [ Time Frame: The time from regsitration date to the date of death ]
    Overall survival time
  • Duration until development of acneiforme follicular exanthema >= grade 2 [ Time Frame: approximately 12 months ]
    Duration until development of acneiforme follicular exanthema >= grade 2 during treatment-phase
  • Development of paronychia [ Time Frame: approximately 12 months ]
    Development of paronychia during treatment-phase
  • Development of skin fissure (hand and foot) [ Time Frame: approximately 12 months ]
    Development of skin fissure (hand and foot) during treatment-phase
  • Rate of secondary resections of metastasis of liver with a curative approach [ Time Frame: approximately 12 months ]
    Rate of secondary resections of metastasis of liver with a curative approach during treatment-phase
  • Assessment of safety and tolerability [ Time Frame: approximately 12 months ]
    Assessment of safety and tolerability during treatment phase
  • Development of acneiforme follicular exanthema >= grade2 [ Time Frame: approximately 12 months ]
    Development of acneiforme follicular exanthema >= grade2 during treatment phase


Original Secondary Outcome: Same as current

Information By: Johannes Gutenberg University Mainz

Dates:
Date Received: March 11, 2011
Date Started: January 2011
Date Completion: March 2018
Last Updated: December 17, 2013
Last Verified: December 2013