NCT01315990

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

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 Prevent Acneiforme Follicular Exanthema

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 165 (estimated)
• Sponsor: Dr. Carl Schimanski · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 description

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

Conditions

• Colorectal Cancer Metastatic

Interventions

Type	Name	Description
DRUG	FOLFIRI + Cetuximab	1. Cetuximab (Erbitux® )- Cetuximab is a recombinant IgG1 chimeric monoclonal antibody directed against human epidermal growth factor receptor (EGFR). 2. FOLFIRI regimen Administration Schedule: Cetuximab at a initial dose 400 mg/sqm (first week), then 250 mg/sqm on day 1 and 8 Background Chemotherapy (every two weeks) * Irinotecan 180 mg/m² iv , 90 min on day 1 * Folic acid (racemic) 400 mg/m², 120 min on day 1 * 5-FU 400 mg/m² bolus on day 1 * 5-FU 2400 mg/m² iv over 46 h on day 1 to 2

Timeline

• Start date: 2011-01-01
• Primary completion: 2015-03-01
• Completion: 2018-03-01
• First posted: 2011-03-16
• Last updated: 2013-12-18

Locations

1 site across 1 country: Germany