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| Sponsor: | The Nordic Colorectal Cancer Biomodulation Group |
|---|---|
| Information provided by: | The Nordic Colorectal Cancer Biomodulation Group |
| ClinicalTrials.gov Identifier: | NCT00145314 |
Purpose
The main objective of this trial is to explore the effect of combining an established chemotherapy regimen (FLOX), based on 5-fluorouracil, folinic acid, and oxaliplatin (Eloxatin®), with the EGF receptor antibody cetuximab (Erbitux®) in first-line treatment of metastatic colorectal cancer. The trial will investigate two regimens of FLOX plus cetuximab, in which FLOX is given continuously or intermittently, compared to standard FLOX without cetuximab.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Colorectal Cancer |
Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | 5-Fluorouracil/Folinate/Oxaliplatin (Eloxatin) (FLOX Regimen), Given Continuously or Intermittently, in Combination With Cetuximab (Erbitux), in First-Line Treatment of Metastatic Colorectal Cancer. A Phase III Multicenter Trial. |
| Enrollment: | 571 |
| Study Start Date: | May 2005 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Active Comparator
FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly
|
Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin)
FLOX every 2nd week
|
|
B: Experimental
FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab
|
Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab
FLOX every 2nd week Cetuximab weekly
|
|
C: Experimental
FLOX given intermittently and maintenance cetuximab
|
Drug: FLOX (5-fluorouracil and folinic acid and oxaliplatin) intermittently and maintenance cetuximab
FLOX every 2nd week for 8 cycles. Stop of FLOX until progression then FLOX is reintroduced. Cetuximab weekly. |
Eligibility| Ages Eligible for Study: | 18 Years to 74 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Histology and staging disease:
General conditions:
Exclusion Criteria:
Prior therapy:
Prior or current history:
Concomitant treatments:
Other:
Contacts and Locations| Norway | |
| The Nordic Colorectal Cancer Biomodulation Group | |
| Oslo, Norway, NO-0407 | |
| Principal Investigator: | Kjell M. Tveit, MD, PhD | Professor at Ullevål University Hospital, Norway |
More Information
| Responsible Party: | The Nordic Colorectal Cancer Biomodulation Group ( Kjell M. Tveit, MD, PhD ) |
| Study ID Numbers: | Nordic VII, EudraCT no.: 2005-000117-34 |
| Study First Received: | September 2, 2005 |
| Last Updated: | January 31, 2008 |
| ClinicalTrials.gov Identifier: | NCT00145314 History of Changes |
| Health Authority: | Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency; Denmark: National Board of Health; Finland: Finnish Medicines Agency |
|
Metastatic colorectal cancer FLOX Cetuximab |
|
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Gastrointestinal Diseases Antineoplastic Agents Hematologic Agents Colonic Diseases Physiological Effects of Drugs Leucovorin Rectal Diseases Oxaliplatin Neoplasms by Site Vitamins Therapeutic Uses |
Micronutrients Vitamin B Complex Digestive System Neoplasms Hematinics Growth Substances Cetuximab Intestinal Diseases Immunosuppressive Agents Intestinal Neoplasms Pharmacologic Actions Folic Acid Neoplasms Digestive System Diseases Fluorouracil Gastrointestinal Neoplasms |