Study Assessing Potential Predictive Tumor Markers in Metastatic Colorectal Cancer

Summary

To estimate the progression free survival for subjects treated with panitumumab in combination with a chemotherapy regimen of oxaliplatin, 5-Fluorouracil (5-FU) and leucovorin (FOLFOX) as first-line chemotherapy regimen for subjects with metastatic colorectal cancer with WT (wild type) KRAS according to the IGFRp (protein receptor insulin growth factor) and MMP-7 (Matrilysin) expression.

Conditions

• Metastatic Colorectal Cancer

Interventions

DRUG

Panitumumab + FOLFOX (DP)

Panitumumab and FOLFOX will be administered to patients with DP once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.

DRUG

Panitumumab + FOLFOX (no-DP)

Panitumumab and FOLFOX will be administered to patients with no-DP (MMP7+/p-IGF-IR-, MMP7-/p-IGF-IR+ or MMP7-/p-IGF-IR) once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.

Sponsors & Collaborators

• Amgen

  collaborator INDUSTRY

• TFS Trial Form Support

  collaborator INDUSTRY

• Grupo Espanol Multidisciplinario del Cancer Digestivo

  lead OTHER

Principal Investigators

• Joan Maurel, MD · Hospital Clinic i provincial de Barcelona

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

• Antonia Salud, MD · Hospital Arnau de Vilanova de Lleida

• Antonio Arrivi, MD · Hospital Son Llatzer de Mallorca

• Xavier Hernández, MD · Intitut Català d' Oncologia (ICO) de Girona

• Ólbia Serra, MD · Hospital General de l'Hospitalet de Barcelona

• Carles Pericay, MD · Corporació Sanitaria Parc Taulí de Barcelona

• Isabel Busquier, MD · Consorcio Hospitalario Provincial de Castellon

• Carlos Fernandez-Martos, MD · Instituto Valenciano de Oncología de Valencia

• Jorge Aparicio, MD · Hospital Universitario La Fe de Valencia

• Maria José Safont, MD · Hospital General Universitario de Valencia

• Carles Bosch, MD · Hospital Dr. Peset de Valencia

• Javier Gallego, MD · Hosptial General Universitario de Elche

• Alberto Carmona, MD · Hosptial Morales Meseguer

• Jaume Feliu, MD · Hosptial Universitario La Paz de Madrid

• Ana Ruíz, MD · Hospital de Fuenlabrada de Madrid

• Enrique Casado, MD · Hospital Infanta Sofía de Madrid

• Ricardo Cubedo, MD · Hospital Universitario Puerta de Hierro de Madrid

• Juana Maria Cano, MD · Hosptial General de Ciudad Real

• Vicente Alonso, MD · Hospital Miguel Servet de Zaragoza

• Monica Jorge, MD · Hospital Xeral Cies de Vigo

• Herminio Manzano, MD · Hospital Son Dureta de Mallorca

• Javier Rodríguez, MD · Clínica Universitaria de Navarra

• Uriel Bohn, MD · Hosptial Dr. Negrin de Las Palmas de Gran Canaria

• Miriam Zorrilla, MD · Hospital de Logroño

• Ruth Vera, MD · Hospital de Navarra

• Carlos García, MD · Complejo Asistencial de Burgos. Hospital General Yague

• Santiago Albiol, MD · Hospital de l'Esperit Sant de Barcelona

• José Carlos Méndez, MD · Centro Oncológico de Galicia (La Coruña)

• Francisco Javier Ramos, MD · Hospital de Sant Pau i Santa Tecla de Tarragona

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-11-08

Primary Completion

2015-02-13

Completion

2015-02-13

Countries

• Spain

Study Locations