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A Clinical Trial of Panitumumab in Combination With FOLFIRI Chemotherapy as Second Line Treatment in Subjects With Metastatic Colorectal Cancer Expressing Wild-type KRAS and Who Had Progressed ≥ 6 Months After the Last Dose of the First Line Chemotherapy

NCT01144195 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2010-11-10

No results posted yet for this study

Summary

First line chemotherapy treatment regimens for metastatic colorectal cancer (mCRC) present disease-free survival of more than 10 months, and as much as 12 and 15 months for many patients.

It is evident that there are 2 groups of patients with metastatic colorectal cancer(mCRC): those who progress during first line treatment or in the 6 months following the last chemotherapy infusion and those who progress after this first 6-month period.

There are currently no studies evaluating the efficacy of second line chemotherapy regimens according to the duration of response to first line treatment. It seems logical that patients with less aggressive tumours will benefit more from treatments targeting specific proteins, such as panitumumab, due to the shorter duration of these tumours cell cycle, which makes them less sensitive to chemotherapy.

This study is therefore justified to determine an increase in activity and control of the disease in patients who progressed after 6 months of the last first line chemotherapy infusion for metastatic colorectal cancer(mCRC) in subjects expressing wild-type KRAS.

Conditions

Interventions

DRUG

Panitumumab + FOLFIRI

Panitumumab will be administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks. FOLFIRI chemotherapy will be administered once every 2 weeks after the administration of Panitumumab.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Associacio catalana per a la recerca oncologica i les seves implicacions sanitaries i socials

    lead OTHER

Principal Investigators

  • Carles Pericay, MD PhD · Corporació Sanitaria Parc Taulí, Sabadell (Spain)

  • Ferran Losa, Dr. · Hospital General de l'Hospitalet

  • Pilar Vicente, Dra. · Hospital General de Granollers

  • Hermini Manzano, Dr. · Hospital Son Dureta

  • Juan Manuel Campos, Dr. · Hospital Arnau de Vilanova (Valencia)

  • Joan Manel Gasent, Dr. · Hospital de Denia

  • Enrique Barrajón, Dr. · Clínica de Benidorm

  • Inma Guasch, Dra. · Hospital General de Manresa

  • Antonia Salud, Dra. · Hospital Arnau de Vilanova (Lleida)

  • Miquel Nogué, Dr. · Hospital General de Vic

  • Inés Cabezas, Dra. · Hospital Sant Joan de Reus

  • Jordi Alfaro, MD · Consorci Sanitari de Terrassa

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-12-31

Countries

  • Spain

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01144195 on ClinicalTrials.gov