FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer - Full Text View

Sponsor:	Sirtex Medical
Information provided by:	Sirtex Medical
ClinicalTrials.gov Identifier:	NCT00724503

Purpose

This study is a randomized multi-center trial that will assess the effect of adding SIRT, using SIR-Spheres microspheres, to a standard chemotherapy regimen of FOLFOX as first line therapy in patients with non-resectable liver metastases from primary colorectal adenocarcinoma.

Condition	Intervention	Phase
Colorectal Cancer Colorectal Carcinoma Liver Metastases	Drug: Systemic chemotherapy (FOLFOX) Device: SIR-Spheres yttrium-90 microspheres	Phase II Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
Official Title:	Randomised Comparative Study Of Folfox6m Plus Sir-Spheres® Microspheres Versus Folfox6m Alone As First Line Treatment In Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Colorectal Cancer

U.S. FDA Resources

Further study details as provided by Sirtex Medical:

Primary Outcome Measures:

progression free survival [ Time Frame: from randomisation until progressive disease is confirmed or upon patient death if disease progression has not been evident at that time ] [ Designated as safety issue: No ]

Estimated Enrollment:	318
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Active Comparator Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX)	Drug: Systemic chemotherapy (FOLFOX) Oxaliplatin 85 mg/m2, IV infusion, q two weeks Leucovorin 200 mg/m2, IV infusion, q two weeks 5-Fluorouracil 400 mg/m2, IV bolus, q two weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks
B: Active Comparator A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)	Device: SIR-Spheres yttrium-90 microspheres SIR-Spheres microspheres implanted once on the 3rd or 4th day of the first week of the first chemotherapy cycle Drug: Systemic chemotherapy (FOLFOX) Oxaliplatin 60 mg/m2,IV infusion, q two weeks for first 3 cycles Oxaliplatin 85 mg/m2, IV infusion, q two weeks from cycle 4 onwards Leucovorin 200 mg/m2, IV infusion, q two weeks 5-Fluorouracil 400 mg/m2, IV bolus, q two weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks

Arms

Assigned Interventions

A: Active Comparator

Systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5- Fluorouracil (FOLFOX)

Drug: Systemic chemotherapy (FOLFOX)

Oxaliplatin 85 mg/m2, IV infusion, q two weeks

Leucovorin 200 mg/m2, IV infusion, q two weeks

5-Fluorouracil 400 mg/m2, IV bolus, q two weeks

5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks

B: Active Comparator

A single injection of SIR-Spheres microspheres into the liver plus systemic chemotherapy consisting of Oxaliplatin + Leucovorin + 5-Fluorouracil (FOLFOX)

Device: SIR-Spheres yttrium-90 microspheres

SIR-Spheres microspheres implanted once on the 3rd or 4th day of the first week of the first chemotherapy cycle

Drug: Systemic chemotherapy (FOLFOX)

Oxaliplatin 60 mg/m2,IV infusion, q two weeks for first 3 cycles

Oxaliplatin 85 mg/m2, IV infusion, q two weeks from cycle 4 onwards

Leucovorin 200 mg/m2, IV infusion, q two weeks

5-Fluorouracil 400 mg/m2, IV bolus, q two weeks

5-Fluorouracil 2.4 g/m2, IV infusion, q two weeks

Eligibility

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

Criteria

Inclusion Criteria:

Histologically confirmed adenocarcinoma of the colon or rectum OR radiological evidence of carcinoma of the colon or rectum.
Measurable evidence of non-resectable liver metastases
Adequate haematological, renal and hepatic function

Exclusion Criteria:

Evidence of ascites, cirrhosis, portal hypertension, main portal venous tumour involvement or thrombosis
Any extra-hepatic metastases
Prior chemotherapy for metastatic colorectal cancer
Pregnant or breast feeding

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00724503

Contacts

Contact: Sandra Monte, CCRA

888-474-7839 ext 712

smonte@sirtex.com

Show 37 Study Locations

Sponsors and Collaborators

Sirtex Medical

Investigators

Principal Investigator:	Peter Gibbs, MD	Melbourne Health
Principal Investigator:	Guy van Hazel, MD	Mount Medical Centre

More Information

No publications provided

Responsible Party:	Sirtex Technology Pty Ltd ( David Cade, MD, Medical Director )
Study ID Numbers:	STX0206
Study First Received:	July 25, 2008
Last Updated:	February 3, 2010
ClinicalTrials.gov Identifier:	NCT00724503 History of Changes
Health Authority:	United States: Food and Drug Administration; Australia: Human Research Ethics Committee; Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Sirtex Medical:

colon cancer
Colorectal carcinoma
liver metastases

SIR-Spheres microspheres
yttrium-90
FOLFOX

Additional relevant MeSH terms:

Liver Diseases
Neoplasms by Histologic Type
Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms
Carcinoma
Liver Neoplasms

Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Digestive System Diseases
Neoplasm Metastasis
Gastrointestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on February 08, 2010