A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
18 Years
N/A
Both
Metastatic Colorectal Cancer
Trial Information
A Randomised, Open-label Phase II Study Evaluating the Efficacy and Safety of Folfox6 + Cetuximab as First-line Therapy in Patients With Metastatic Colorectal Cancer
The multicenter randomized phase II study will enroll a target of approximately 150
first-line patients with metastatic CRC.
EGFR expression is not required for study entry, however, the EGFR status will be measured
retrospectively.
Patients are randomized to Arm A or Arm B. Arm A: FOLFOX 6 in combination with cetuximab Arm
B: FOLFIRI in combination with cetuximab. Both efficacy and safety data will be collected.
The investigators will assess response to treatment at 6 weeks, 12 weeks and thereafter
every 12 weeks based on imaging Following permanent treatment cessation (stop of all study
treatments) patients will be followed-up for.
Inclusion Criteria:
- Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
- Metastatic colorectal carcinoma not suitable for curative-intent resection
- Availability of tumor sample (or able and willing to provide tumor sample) for EGFR
assessment
- Presence of at least one lesion measurable unidimensional by CT scan or MRI (Target
lesion(s) must not lie within an irradiated area)
- ECOG performance status of < 2 at study entry
Exclusion Criteria:
- Brain metastasis (known or suspected)
- Previous chemotherapy for metastatic CRC or adjuvant therapy with oxaliplatin or
irinotecan. Adjuvant therapy with 5 FU or derivatives is allowed if the chemotherapy
treatment free interval is > 6 months
- Surgery (excluding diagnostic biopsy) or irritation within 4 weeks prior to study
entry
- Cocurrent chronic systemic immune therapy, chemotherapy, or hormone therapy not
indicated in the study protocol
- Any investigational agent(s) within 4 weeks prior to entry
- Previous exposure to EGFR-pathway targeting therapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
the percentage of patients surviving without disease progression in each arm at 9 months
Principal Investigator
Werner Scheithauer, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Dep. of Internal Medicine I, Medical University of Vienna
Authority:
Austria: Federal Ministry for Health and Women
Study ID:
CECOG/Core 1.2.001
NCT ID:
NCT00286130
Start Date:
July 2005
Completion Date:
October 2007
Related Keywords:
- Metastatic Colorectal Cancer
- metastatic colorectal cancer
- FOLFOX 6
- FOLFIRI
- Colorectal Neoplasms
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