Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Neoplasm Metastasis, Colorectal Cancer

Thank you

Trial Information

Open, Randomized, Controlled, Multicenter Phase II Study Comparing 5-FU/FA Plus Oxaliplatin (FOLFOX-4) Plus Cetuximab Versus 5-FU/FA Plus Oxaliplatin (FOLFOX-4) as First-line Treatment for Epidermal Growth Factor Receptor-expressing Metastatic Colorectal Cancer


Inclusion Criteria:



- First-line mCRC

- EGFR positive

- Bi-dimensional measurable index lesion

Exclusion Criteria:

- Previous exposure to EGFR-targeting therapy

- Previous oxaliplatin-based therapy

- Previous chemotherapy for colorectal cancer except adjuvant treatment with
progression of disease documented > 6 months after end of adjuvant treatment

- Radiotherapy

- Surgery

- Any other investigational drug in the 30 days before randomization

- Brain metastasis and/or leptomeningeal disease

- Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Best Overall Response Rate - Independent Review Committee (IRC)

Outcome Description:

The best overall response rate is defined as the percentage of subjects having achieved confirmed Complete Response + Partial Response as the best overall response according to radiological assessments (based on modified World Health Organisation (WHO) criteria) as assessed by an IRC.

Outcome Time Frame:

Evaluations were performed every 6 weeks until progression, reported between day of first patient randomised, 27 Jul 2005, until cut-off date 4 August 2006

Safety Issue:

No

Principal Investigator

Bokemeyer, Prof. Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Klinik für Onkologie, Hämatologie und Knochenmarktransplantationen Universitätsklinikum Hamburg-Eppendorf, Germany

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

EMR 62202-047

NCT ID:

NCT00125034

Start Date:

July 2005

Completion Date:

November 2010

Related Keywords:

  • Neoplasm Metastasis
  • Colorectal Cancer
  • FOLFOX-4
  • Cetuximab
  • First-line mCRC
  • EGFR positive
  • metastatic CRC
  • first-line MCRC
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location