Vectibix for the Treatment of Anal Cancer

Summary

Chemoradiation with 5-FU and Mitomycin C is the standard treatment in anal canal SCC. Panitumumab has shown efficacy in other tumors and anti-EGFR treatment has shown clinical activity in a single report of a refractory anal canal SCC patient. Based on this background, we propose to conduct a phase II study to investigate the efficacy and toxicity of radiotherapy with the association:

* 5-FU 1000mg/m2 on days 1-4 and 29-32
* Mitomycin C 10mg/m2 on days 1 and 29
* Panitumumab 6 mg/kg on day 1, then every 2 weeks for 8 weeks

Conditions

• Anal Squamous Cell Carcinoma

Interventions

DRUG

panitumumab, mytomicin C, 5-FU, radiation

Radiation therapy will be administered concurrent with chemotherapy and Panitumumab treatment. It will start the day 1 of the systemic treatment. That is, the first day of radiation therapy will be the day of the administration of the first dose of Panitumumab and Mitomycin C, as well as the first day of the first 96-hours course of 5-FU continuous infusion. On day 1, drugs and radiation will be administered in the following order: * First, Panitumumab. Panitumumab will be administered by IV infusion on day 1, and every 2 weeks during 8 weeks * Then Mitomycin C, 10mg/m2 on days 1 and 29 * Then start the 5-FU continuous infusion, 1000mg/m2 on days 1-4 and 29-32 * Finally, no less than 2 hours after the start of the 5-FU infusion, first dose of radiation therapy.

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• Trial Form Support S.L.

  collaborator OTHER

• Grupo Espanol Multidisciplinario del Cancer Digestivo

  lead OTHER

Principal Investigators

• Jaime Feliu, MD · Hospital Universitario La Paz

• Vicente Alonso, MD · Hospital Miguel Servet

• Jaume Capdevila, MD · Hospital Universitario Vall Hebron

• Ruth Vera, MD · Hospital de Navarra

• Miriam Lopez, MD · Hospital Infanta Sofia

• Carmen Castañon, MD · Hospital Virgen Blanca (León)

• Carlos Fernández-Martos, MD · Instituto Valenciano de Oncología

• Clara Montagut, MD · Hospital del Mar

• Carlos García Girón, MD · Hospital General Yagüe (Burgos)

• Ana León, MD · Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

• Marta Martín, MD · Hospital de la Santa Creu i Sant Pau de Barcelona

• Juan Carlos Méndez, MD · Centro Oncológico de Galicia

• Rocío García Carbonero, MD · Hospital Universitario Virgen del Rocío (Sevilla)

• Jordi Remon, MD · Hospital de Mataró

• Fernando Rivera, MD · Hospital Universitario Marqués de Valdecilla (Santander)

• Laura Cerezo, MD · Hospital Universitario La Princesa (Madrid)

• Pilar García-Alfonso, MD · Hospital Universitario Gregorio Marañón (Madrid)

• Emilio Fonseca, MD · University of Salamanca

• Aleydis Pisa, MD · Corporació Sanitaria Parc Taulí (Sabadell, Barcelona)

• Mónica Caro, MD · Institut Català d´Oncologia. Hospital Germans Trias i Pujol (Badalona)

• José María Vicent, MD · Hospital de Manises, Valencia

• Isabel Sevilla, MD · Hospital Universitario Virgen de la Victoria (Málaga)

• Joan Maurel, MD · Hospital Clinic of Barcelona

• I Guasch, MD · Hospital Sant Joan de Deu

• Jesus Garcia-Foncillas, MD · Clinica Universidad de Navarra

• Antonio Arrivi, MD · Hospital Son Llatzer

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-10-31

Primary Completion

2017-03-24

Completion

2017-03-24

Countries

• Spain

Study Locations