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Safety and Efficacy Study of FOLFOX4+Panitumumab vs.FOLFIRI+Panitumumab in Subjects WT KRAS Colorectal Cancer and Liver-only Metastases

NCT00885885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-08-01

No results posted yet for this study

Summary

The purpose of the study is to evaluate the efficacy and safety of the combination of Panitumumab with FOLFOX 4 Chemotherapy or Panitumumab with FOLFIRI Chemotherapy in Subjects with Wild- Type KRAS Colorectal Cancer and liver-only Metastases.

Conditions

Interventions

DRUG

Panitumumab+FOLFOX-4

Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes. A cycle of panitumumab is defined as 14 days. FOLFOX 4 chemotherapy will be administered on day 1 of each 14-day treatment cycle: * Oxaliplatin 85mg/m2 as a 120 minute infusion on day 1 of each cycle * Folinic acid 200mg/m2 as a 120 minute infusion on days 1 and 2 * A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on days 1 and 2 * 5-FU at 600mg/m2 as a continuous infusion of 22 hour infusion on days 1 and 2

DRUG

Panitumumab+FOLFIRI

Panitumumab will be administered as a 60-minute ± 15 minutes IV infusion, just prior to administration of chemotherapy at a dose of 6 mg/kg on day 1 of each cycle. If the first infusion of panitumumab is well tolerated (without any serious infusion related reactions) all subsequent infusions may be administered over 30 minutes ± 10 minutes. A cycle of panitumumab is defined as 14 days. FOLFIRI chemotherapy will be administered on day 1 of each 14-day treatment cycle: * Irinotecan 180 mg/m2 will be administered over 90 minutes ± 15 minutes on day 1 of each cycle * Folinic acid 400 mg/m2 will be administered over 2 hours ± 15 minutes during the irinotecan infusion but without mixing * A bolus (2 to 4 minutes) of 5-FU at 400mg/m2 on day 1 * 5-FU at 2400 mg/m2 continuous intravenous infusion over 46-hour ± 2-hour on day 1 of each cycle.

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

    lead OTHER

Principal Investigators

  • Albert Abad, MD, phD · ICO-H. Germans Trial i Pujol. Badalona. Spain

  • Alfredo Carrato, MD, phD · Hospial Ramón y Cajal. Madrid. Spain

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-05-31
Primary Completion
2015-03-31
Completion
2015-03-31

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 NCT00885885 on ClinicalTrials.gov