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 (Responsible Party):	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.

Treatment with the biologic agent bevacizumab, if part of the standard of care at participating institutions, is allowed within this study at the discretion of the treating Investigator.

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
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

Drug Information available for: Fluorouracil Oxaliplatin

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:	450
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A: FOLFOX alone 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 Other Name: FOLFOX6m
Active Comparator: B: FOLFOX + SIR-Spheres 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 Other Names: SIRT SIR-Spheres Y-90 microspheres 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 Other Name: FOLFOX6m

Arms

Assigned Interventions

Active Comparator: A: FOLFOX alone

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

Other Name: FOLFOX6m

Active Comparator: B: FOLFOX + SIR-Spheres

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

Other Names:

SIRT
SIR-Spheres Y-90 microspheres

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

Other Name: FOLFOX6m

Eligibility

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

Criteria

Inclusion Criteria:

Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation.
Limited extra-hepatic metastases in the lung and/or lymph nodes are permitted (Lung: 5 lesions total, < 1 cm, or 1 single lesion of up to 1.7 cm; Lymph nodules in one single anatomic area (pelvis, abdomen or chest): any number, < 2 cm).
Suitable for either treatment regimen.
Prior chemotherapy for metastatic colorectal cancer is not allowed.
WHO performance status 0-1.
Adequate hematological, renal and hepatic function.
Age 18 years or older.
Willing and able to provide written informed consent.
Life expectancy of at least 3 months without any active treatment.

Exclusion Criteria

Evidence of ascites, cirrhosis, portal hypertension, main portal or venous tumor involvement or thrombosis as determined by clinical or radiologic assessment.
Previous radiotherapy delivered to the upper abdomen.
Non-malignant disease that would render the patient unsuitable for treatment according to the protocol.
Peripheral neuropathy > grade 1 (NCI-CTC).
Dose limiting toxicity with previous adjuvant 5-FU or oxaliplatin chemotherapy.
Prior non-adjuvant chemotherapy for any malignancy. Adjuvant chemotherapy for colorectal cancer is not an exclusion criteria provided that it was completed more than 6 months before entry into the study.
Pregnant or breast-feeding.
Other active malignancy.

Contacts and Locations

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

Contacts

Contact: Henk Tissing	+31 26 3391124	htissing@sirtex-europe.com
Contact: Janet Bell, M.B.A.	888-474-7839 ext 710	jbell@sirtex.com

Show 126 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 Medical
ClinicalTrials.gov Identifier:	NCT00724503 History of Changes
Other Study ID Numbers:	STX0206
Study First Received:	July 25, 2008
Last Updated:	May 4, 2012
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
bevacizumab
metastatic colorectal cancer

Additional relevant MeSH terms:

Carcinoma
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Fluorouracil
Oxaliplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2012