Intensified Chemotherapy in CRC After Resection of Liver Metastases - Full Text View

Sponsors and Collaborators:	Centre Val d'Aurelle - Paul Lamarque Pfizer Sanofi-Aventis Chugai Pharmaceutical
Information provided by:	Centre Val d'Aurelle - Paul Lamarque
ClinicalTrials.gov Identifier:	NCT00208260

Purpose

Randomized, open label, multicentre phase II trial followed by phase III comparing overall survival after having selected the best experimental arm.

Condition	Intervention	Phase
Colorectal Cancer Liver Metastases Chemotherapy	Drug: FOLFIRI Drug: FOLFOX-4 Drug: FOLFIRI-HD Drug: FOLFOX-7 Drug: FOLFIRINOX	Phase II Phase III

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Phase II Trial Followed by Phase III Trial With Molecular Biology Study, Comparing a Standard bi-Therapy vs 3 Arms of Intensified Chemotherapy in Patients With Unresectable or Not Optimally Resectable Colorectal Cancer Liver Metastases.

Further study details as provided by Centre Val d'Aurelle - Paul Lamarque:

Primary Outcome Measures:

Response [ Time Frame: end of chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety [ Time Frame: during study treatment ] [ Designated as safety issue: Yes ]
Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary resection [ Time Frame: surgery after chemotherapy ] [ Designated as safety issue: No ]

Enrollment:	124
Study Start Date:	April 2004
Study Completion Date:	August 2007

Arms	Assigned Interventions
A: Active Comparator FOLFIRI	Drug: FOLFIRI FOLFIRI : Irinotecan : 180 mg/m² 90 min continuous perfusion during levorin d1 every 2 weeks
B: Active Comparator FOLFOX-4	Drug: FOLFOX-4 FOLFOX 4 : Oxaliplatine : 85 mg/m² 2h continuous perfusion during levorin d1 every 2weeks
C: Experimental FOLFIRI-HD	Drug: FOLFIRI-HD High Dose FOLFIRI : Irinotecan : 260 mg/m² in 90min continuous perfusion during levorin d1 every 2 weeks
D: Experimental FOLFOX-7	Drug: FOLFOX-7 FOLFOX 7 : Oxaliplatine : 130 mg/m² in 2h continuous perfusion during levorin d1 every 2 weeks
E: Experimental FOLFIRINOX	Drug: FOLFIRINOX FOLFIRINOX : Oxaliplatine : 85 mg/m² 2h continuous perfusion followed by 1H rest followed by 90 min continuous perfusion of irinotecan : 180 mg/m² during levorin d1 every 2 weeks

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically proven adenocarcinoma of the colon or rectum without previous resection, or clinically asymptomatic (with or without stent)
Hepatic unresectable metastases R0: due to close vascular contact, or due to liver remaining mass less than 25 to 30 % of functional liver.
Not optimally resectable metastases
Extra-hepatic disease will be accepted in case of: asymptomatic primary tumour or tumor requiring no urgent surgery (in less than 3 months); three of less than three lung metastases (thoracic scan diameter less than 2 cm) and potentially respectable.
Synchronous and metachronous hepatic metastases
WHO performance status 0-1
Adjuvant chemotherapy allowed, except oxaliplatin and irinotecan based combination.
No prior treatment of the liver metastases, whatever.
Life expectancy equal or more than 3 months

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00208260

Locations

France
CRLC Val d'Aurelle
MONTPELLIER, France, 34298

Sponsors and Collaborators

Centre Val d'Aurelle - Paul Lamarque

Pfizer

Sanofi-Aventis

Chugai Pharmaceutical

Investigators

Principal Investigator:	Marc YCHOU, MD, PhD	CRLC Val d'Aurelle
Study Chair:	Michel RIVOIRE, MD	CRLC Leon Berard - Lyon

More Information

No publications provided

Study ID Numbers:	METHEP/2004/22
Study First Received:	September 13, 2005
Last Updated:	December 13, 2007
ClinicalTrials.gov Identifier:	NCT00208260 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Liver Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Liver Neoplasms
Oxaliplatin
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

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

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009