Oxaliplatin and Cetuximab in First-Line Treatment of Metastatic Colorectal Cancer (mCRC) - Full Text View

Sponsored by:	Merck KGaA
Information provided by:	EMD Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00125034

Purpose

This is an open label, randomized, controlled, multicenter phase II study comparing 5-FU/FA + oxaliplatin (FOLFOX-4) + cetuximab versus 5-FU/FA + oxaliplatin as first-line treatment for epidermal growth factor receptor (EGFR)-expressing mCRC.

Condition	Intervention	Phase
Neoplasm Metastasis Colorectal Cancer	Drug: Cetuximab Drug: Oxaliplatin	Phase II

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Fluorouracil Oxaliplatin Cetuximab Epidermal Growth Factor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	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

Further study details as provided by EMD Pharmaceuticals:

Primary Outcome Measures:

effectivity [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

curative metastatic surgery [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ]
duration of response [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ]
disease control rate [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ]
progression-free survival time [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ]
overall survival time [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ]
safety [ Time Frame: various timepoints ] [ Designated as safety issue: Yes ]

Enrollment:	345
Study Start Date:	July 2005
Estimated Study Completion Date:	June 2008
Primary Completion Date:	June 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: Cetuximab Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m2/day IV over 2-4 minutes followed by 600 mg/m2/day infused over 22-hour, on day 1 and day 2, every two weeks).
2: Active Comparator	Drug: Oxaliplatin Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m2/day IV over 2-4 minutes followed by 600 mg/m2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops

Arms

Assigned Interventions

1: Experimental

Drug: Cetuximab

Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m2/day IV over 2-4 minutes followed by 600 mg/m2/day infused over 22-hour, on day 1 and day 2, every two weeks).

2: Active Comparator

Drug: Oxaliplatin

Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m2/day IV over 2-4 minutes followed by 600 mg/m2/day infused over 22-hour, on day 1 and day 2, every two weeks).

Until progression or unacceptable toxicity develops

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00125034

Show 78 Study Locations

Sponsors and Collaborators

Merck KGaA

Investigators

Principal Investigator:

Bokemeyer, Prof. Dr.

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

More Information

Responsible Party:	Merck Serono ( Esther Prang )
Study ID Numbers:	EMR 62202-047
Study First Received:	July 28, 2005
Last Updated:	June 17, 2008
ClinicalTrials.gov Identifier:	NCT00125034
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by EMD Pharmaceuticals:

FOLFOX-4
Cetuximab
First-line mCRC
EGFR positive

metastatic CRC
first-line MCRC
EGFR positive
metastatic CRC

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Cetuximab
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Oxaliplatin
Digestive System Diseases
Fluorouracil
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site

Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009