drugset / Trial / 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
NaSingle-groupOpen-labelTreatment
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
Timeline
- Start
- 2012-06
- Primary completion
- 2020-01
- Completion
- 2020-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cetuximab | Monoclonal antibody | — | Intravenous |
| Subject | Mitomycin C | Other / unclassified | 8 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 800 mg/m2 | Intravenous |