MedTrace Logo

Study to Evaluate the Effects of Panitumumab if Combined With Chemotherapy for 2nd Treatment of Colorectal Cancer

NCT00950820 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2013-03-04

No results posted yet for this study

Summary

The purpose of this interventional study is to investigate whether there is evidence that panitumumab in combination with XELOX (capecitabine plus oxaliplatin) chemotherapy will safely increase progression-free survival, above that of XELOX alone in subjects with KRAS wild-type metastatic colorectal cancer who have not responded to or progressed after first line therapy with irinotecan and a fluoropyrimidine.

Further Objectives Exploratory objectives may include investigation of potential correlations between the treatment regimen and epidermal growth factor receptor (EGFR) expression, detection of the functional genetic polymorphisms of the EGFR gene, EGFR gene amplification (FISH), EGFR downstream protein and gene expression parameters, proteomics and epigenetics.

Conditions

  • Colorectal Neoplasms

Interventions

DRUG

Oxaliplatin, Capecitabine, Panitumumab

Panitumumab at a dose of 9 mg/kg BW every three weeks will be administered on day 1 of each cycle just prior to administration of chemotherapy. The XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15.

DRUG

Oxaliplatin, Capecitabine

The XELOX regimen is defined as a 2 hour infusion of oxaliplatin 130 mg/m² on day 1 followed by capecitabine 1000 mg/m² bid per os. Capecitabine administration will commence on the evening of day 1 and complete after the morning dose on day 15.

Sponsors & Collaborators

  • iOMEDICO AG

    collaborator INDUSTRY

  • AIO-Studien-gGmbH

    lead OTHER

Principal Investigators

  • Ralf Grunewald, PD Dr. · Gemeinschaftspraxis Hämatologie / Onkologie Im Prüfling 17-19 60389 Frankfurt

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2011-11-30
Completion
2012-03-31

Countries

  • Germany

Study Locations

More Related Trials

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 NCT00950820 on ClinicalTrials.gov