NCT01621217

Phase I Study of Cetuximab in Combination With 5-fluoruracil, Mitomycin C and Radiotherapy in Patients With Anal Cancer Stage T2 (>4 cm) - T4 N0-3 M0 or Any T N2-3 M0

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 21 (estimated)
• Sponsor: Lund University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* To establish maximum tolerated dose of the two cytotoxic drugs 5-fluoruracil and mitomycin C when given together with the antibody cetuximab in patients with locally advanced cancer in the anal region * To evaluate acute toxicity * To evaluate late toxicity * To evaluate response rate * To evaluate recurrence free survival * To evaluate overall survival

Conditions

• Locally Advanced Cancer in the Anal Region

Interventions

Type	Name	Description
DRUG	Cetuximab	Will be given weekly intravenously during study treatment.
DRUG	Mitomycin C	Will be given intravenously twice together with 5-Fluoruracil during study treatment.
DRUG	5-Fluoruracil	Will be given intravenously twice together with Mitomycin C during study treatment
RADIATION	Radiotherapy	Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.

Timeline

• Start date: 2012-06-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2012-06-18
• Last updated: 2020-02-28

Locations

3 sites across 2 countries: Norway, Sweden