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Panitumumab in Combination With Irinotecan Chemotherapy as 2nd-line Therapy in Subjects With mCRC

NCT00475293 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 85

Last updated 2013-09-13

No results posted yet for this study

Summary

The purpose of this study is to assess the objective response rate (ORR) when panitumumab is administered in combination with irinotecan as 2nd-line therapy in subjects with previously treated metastatic colorectal cancer (mCRC).

Conditions

Interventions

DRUG

Panitumumab and CPT-11

Panitumumab will be administered by IV infusion on day 1 of each cycle just prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg Irinotecan: 350 or 300 mg/m2. day 1 One treatment cycle is defined as the 21 day period following the commencement of treatment with panitumumab + irinotecan plus additional time, as needed, for the resolution of irinotecan-related toxicities

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Alfredo Carrato, MD · Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2010-03-31
Completion
2010-03-31

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 NCT00475293 on ClinicalTrials.gov