FLOX in Combination With Cetuximab in First-Line Treatment of Colorectal Cancer - Tabular View

Tracking Information

First Received Date ^ICMJE

September 2, 2005

Last Updated Date

January 31, 2008

Start Date ^ICMJE

May 2005

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To compare efficacy, as measured by time to disease progression, of treatment with cetuximab in combination with the FLOX regimen compared to FLOX alone, in first- line treatment of patients with metastatic cororectal cancer [ Time Frame: Every 4th cycle ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00145314 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To measure response rates, response duration, secondary surgical curative resection frequency, safety profile, overall survival and quality of life in the treatment groups. [ Time Frame: Every 2nd week (safety profile) ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

To measure response rates, response duration, secondary surgical curative resection frequency, safety profile, overall survival and quality of life in the treatment groups.

Descriptive Information

Brief Title ^ICMJE

FLOX in Combination With Cetuximab in First-Line Treatment of Colorectal Cancer

Official Title ^ICMJE

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.

Brief Summary

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.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Metastatic Colorectal Cancer

Intervention ^ICMJE

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

Study Arms / Comparison Groups

Active Comparator: FLOX: 5-fluorouracil/folinic acid/oxaliplatin; Nordic Regimen; given continuosly
Experimental: FLOX: 5-fluorouracil/folinic acid/oxaliplatin and cetuximab
Experimental: FLOX given intermittently and maintenance cetuximab

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

571

Completion Date

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Histology and staging disease:

Histological proven adenocarcinoma of the colon or rectum;
At least one measurable metastatic disease
If only one metastatic lesion and no S-CEA elevation, histology is mandatory;
Availability of tumour sample for EGFR assessment.

General conditions:

Age >18 and < 75 years;
WHO performance status: life expectancy of more than 3 months;
Adequate haematological function
Adequate renal and hepatic functions
Written informed consent

Exclusion Criteria:

Prior therapy:

No prior chemotherapy for advanced/metastatic disease;
No adjuvant chemotherapy the last 6 months before inclusion;
No previous oxaliplatin;

Prior or current history:

No current indication for resection with a curative intent;
No evidence of CNS metastasis;
No current infection, unresolved bowel obstruction or subobstruction, uncontrolled Crohn's disease or ulcerative colitis;
No current history of chronic diarrhoea;
No peripheral neuropathy;
No other serious illness or medical conditions (including contraindication to 5 FU e.g.: angor, myocardial infarction within 6 months, contraindications to monoclonal antibodies);
No past or concurrent history of malignant neoplasm other than colorectal adenocarcinoma within the past five years, except curatively treated non melanoma skin cancer or in situ carcinoma of the cervix;

Concomitant treatments:

No concomitant (or within 4 weeks before randomisation) administration of any other experimental drug under investigation;
No concurrent treatment with any other anti-cancer therapy;

Other:

Not pregnant, no breast feeding
Fertile patients must use adequate contraceptives
Not include patients clearly intending to withdraw from the study if not randomised in the willing arm or patients who cannot be regularly followed up for psychological, social, familiar or geographic reasons.

Gender

Both

Ages

18 Years to 74 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Norway

Administrative Information

NCT ID ^ICMJE

NCT00145314

Responsible Party

Kjell M. Tveit, MD, PhD, The Nordic Colorectal Cancer Biomodulation Group

Study ID Numbers ^ICMJE

Nordic VII, EudraCT no.: 2005-000117-34

Study Sponsor ^ICMJE

The Nordic Colorectal Cancer Biomodulation Group

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Kjell M. Tveit, MD, PhD

Professor at Ullevål University Hospital, Norway

Information Provided By

The Nordic Colorectal Cancer Biomodulation Group

Verification Date

February 2005

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP