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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Study Completion Date: | August 2010 |
| Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: A
FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly
|
Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin)
FLOX every 2nd week
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|
Experimental: B
FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab
|
Drug: FLOX (5-fluorouracil/folinic acid/oxaliplatin) and Cetuximab
FLOX every 2nd week Cetuximab weekly
|
|
Experimental: C
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: | Kjell M. Tveit, MD, PhD, The Nordic Colorectal Cancer Biomodulation Group |
| ClinicalTrials.gov Identifier: | NCT00145314 History of Changes |
| Other Study ID Numbers: | Nordic VII, EudraCT no.: 2005-000117-34 |
| Study First Received: | September 2, 2005 |
| Last Updated: | January 13, 2011 |
| Health Authority: | Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency; Denmark: National Board of Health; Finland: Finnish Medicines Agency |
|
Metastatic colorectal cancer FLOX Cetuximab |
|
Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases Fluorouracil Oxaliplatin Cetuximab Leucovorin |
Folic Acid Levoleucovorin Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Vitamin B Complex Vitamins Micronutrients Growth Substances |