FOLFOX Plus SIR-SPHERES MICROSPHERES Versus FOLFOX Alone in Patients With Liver Mets From Primary Colorectal Cancer (SIRFLOX)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sirtex Medical
ClinicalTrials.gov Identifier:
NCT00724503
First received: July 25, 2008
Last updated: May 27, 2014
Last verified: May 2014
  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:


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: 518
Study Start Date: August 2006
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: September 2014 (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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Hide Study Locations
Locations
United States, Arizona
Pinnacle Oncology Hematology
Scottsdale, Arizona, United States, 85258
United States, California
City of Hope Hospital
Duarte, California, United States, 91010
United States, Florida
Florida International University College of Medicine Practice
North Miami Beach, Florida, United States, 33169
United States, Illinois
Vanguard Health
Berwyn, Illinois, United States, 60402
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Weiss Memorial Hospital
Chicago, Illinois, United States, 60640
Ingalls Memorial Hospital
Harvey, Illinois, United States, 80426
Adventist Hinsdale Hospital
Hinsdale, Illinois, United States, 60525
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
Greenbaum Cancer Center
Glen Burnie, Maryland, United States, 21061
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, Minnesota
Virginia Piper Cancer Institute
Minneapolis, Minnesota, United States, 55407
United States, New Jersey
Holy Name Hospital
Teaneck, New Jersey, United States, 07666
United States, New York
Montefiore Medical Center
Bronx, New York, United States, 10467
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Mecklenburg Medical Group - South Park
Charlotte, North Carolina, United States, 28211
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, United States, 28203
Carolinas Hematology-Oncology Associates - Ballantyne
Charlotte, North Carolina, United States, 28277
Carolinas Hematology-Oncology Associates - University
Charlotte, North Carolina, United States, 28262
Mecklenburg Medical Group - Morehead
Charlotte, North Carolina, United States, 28204
Mecklenburg Medical Group - Pineville
Charlotte, North Carolina, United States, 28210
Levine Cancer Institute - Blumenthal Cancer Center
Charlotte, North Carolina, United States, 28204
Mecklenburg Medical Group
Charlotte, North Carolina, United States, 28204
Levine Cancer Institute
Charlotte, North Carolina, United States, 28211
Carolinas Hematology-Oncology - Ballantyne
Charlotte, North Carolina, United States, 28277
Northeast Oncology Associates
Concord, North Carolina, United States, 28025
Mecklenburg Medical Group - Carolinas Cancer Associates
Monroe, North Carolina, United States, 28112
United States, North Dakota
Altru Health Systems
Grand Forks, North Dakota, United States, 58201
United States, Pennsylvania
UPMC Cancer Center Beaver
Beaver, Pennsylvania, United States, 15009
UPMC Cancer Center Arnold Palmer at Mountain View
Greensburg, Pennsylvania, United States, 15601
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
UPMC Cancer Center Passavant
Pittsburgh, Pennsylvania, United States, 15237
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15232
UPMC Cancer Center Uniontown
Uniontown, Pennsylvania, United States, 15401
United States, Utah
Utah Cancer Specialists - Bountiful/Lakeview Office
Bountiful, Utah, United States, 84010
Utah Cancer Specialists - Layton/Davis Office
Layton, Utah, United States, 84041
Utah Cancer Specialists - Cottonwood Office
Murray, Utah, United States, 84157
Utah Cancer Specialists - Provo Office
Provo, Utah, United States, 84604
Utah Cancer Specialists - Salt Lake Clinic
Salt Lake City, Utah, United States, 84102
Utah Cancer Specialists - Salt Lake Regional
Salt Lake City, Utah, United States, 84102
St. Mark's Hospital
Salt Lake City, Utah, United States, 84124
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Utah Cancer Specialists - Jordan Valley
West Jordan, Utah, United States, 84088
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
United States, Wisconsin
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital
Milwaukee, Wisconsin, United States, 53226
Australia, New South Wales
Concord Hospital
Concord, New South Wales, Australia, 2139
St. Vincent's Hospital
Darlinghurst, New South Wales, Australia, 2010
Nepean Cancer Care Centre
Kingswood, New South Wales, Australia
St. George Hospital
Kogarah, New South Wales, Australia, 2217
Royal North Shore Hospital
St Leonards, New South Wales, Australia, 2065
Sydney Adventist Hospital
Wahroonga, New South Wales, Australia, 2076
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Australia, Queensland
Wesley Medical Centre
Auchenflower, Queensland, Australia, 4066
Cairns Private Hospital
Cairns, Queensland, Australia, 4870
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia, 4029
HOCA Gold Coast Centre
Southport, Queensland, Australia, 4215
Gold Coast Health Service District
Southport, Queensland, Australia, 4215
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5012
Queen Elizabeth II Hospital
Woodville South, South Australia, Australia
Australia, Tasmania
Royal Hobart Hospital
Hobart, Tasmania, Australia, 7000
Australia, Victoria
John Fawkner Private Hospital
Coburg, Victoria, Australia, 3058
Monash Medical Centre
East Bentleigh, Victoria, Australia
Western Hospital
Footscray, Victoria, Australia, 3011
Peninsula Oncology Centre
Frankston, Victoria, Australia, 3199
South Eastern Private
Noble Park, Victoria, Australia, 3174
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Ringwood/Knox Private
Ringwood, Victoria, Australia, 3135
Maroondah Public
Ringwood East, Victoria, Australia, 3135
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Hollywood Private Hospital
Nedlands, Western Australia, Australia, 6009
Mount Medical Centre
Perth, Western Australia, Australia, 6005
Royal Perth Hospital
Perth, Western Australia, Australia
Belgium
OL Vrouw Ziekenhuis Aalst Gastro-Enterologie
Aalst, Belgium, 9300
Antwerp University Hospital
Antwerp, Belgium
ZNA Middelheim
Antwerpen, Belgium, 2020
Imelda Ziekenhuis GI Clinical Research Centre
Bonheiden, Belgium, 2820
Sint-Josef Ziekenhuie (Campus Bornem)
Bornem, Belgium, 2880
Institut Jules Bordet - Centre de Tumeurs d'ULB
Brussels, Belgium
Universiteits Ziekenhuis Gent
Gent, Belgium, 9000
AZ Maria Middelares
Gent, Belgium
Hospital de Jolimont
Haine-Saint-Paul, Belgium, 7100
UZ Leuven, Campus Gasthuisberg
Leuven, Belgium, 3000
Centre Hospitalier Universitaire de Liege
Liege, Belgium
VZW Emmaus St. Maarten Ziekenhuis Mechelen and St. Marten Ziekenhuis Duffel
Mechelen, Belgium, 2800
AZ Heilige Familie
Reet, Belgium, 2840
Sint-Augustinus Ziekenhuis
Wilrijk, Belgium, 2610
France
CHU de Bordeau
Bordeaux, France, 33000
Hospitalier Universitaire de Grenoble C.H.U.
La Tronche, France, 38700
Centre Hospitalier General de Longjumeau
Longjumeau, France, 91161
Hopital de l'Archet II, CHU de Nice
Nice, France, 06202
Hospital European Georges Pompidou
Paris, France, 7590
Centre Eugene Marquis
Rennes Cedex, France
Germany
Internistische Gemeinschaftspraxis
Altstadt, Germany, 84028
Charite Campus Virchow Klinikum
Berlin, Germany, 1335
Universitaetsklinikum Bonn
Bonn, Germany
Johanniterkrankenhaus Bonn
Bonn, Germany
Braxiskooperation Bonn, Fachartze fur Innere Medizin
Bonn, Germany, 53123
Kliniken Essen Mitte
Essen, Germany, 45136
Gemeinschaftspraxis Hamatologie und internistische Onkologie
Essen, Germany
Universitat Frankfurt Institute fur Diagnostic und Interventionelle Radiologie
Frankfurt, Germany, 6059
Universitastsklinikum Saarland
Hamburg, Germany
Asklepios Klinik Altona, Abt. Radiologie, Neuroradiologie, Nuklearmedizin
Hamburg, Germany, 20367
Praxisgemeinschaft Dr. med. Peter Sandor und Peter Kohl
Holzkirch, Germany, 83607
Onklogische Praxis Dr. Gerald Gehbauer
Ingolstadt, Germany, 85049
Klinikum Karlsruhe, Stadtisches Klinikum Karlsruhe, Zentralinstitut fur Bildgebende Diagnostik
Karlsruhe, Germany, 76133
Universitaetsklinikum Magdeburg
Magdeburg, Germany
Schwerpunktpraxis fur Hamatologie und Onkologie
Magdeburg, Germany, 39104
Klinikum Magdeburg GmbH, Klinik für Hämatologie/Onkologie
Magdeburg, Germany, 39130
Universitatsklinikum GieBen und Marburg
Marburg, Germany, 35043
Klinikum der Universitaet Muenchen
Muenchen, Germany
Klinikum Bogenhausen
Muenchen, Germany
Hamato-Onkologische Schwerpunktspraxis
Munchen, Germany
Schwerpunktspraxis fur Hamatologie und Internistische Onkologie
Munchen, Germany
Klinikum rechts der Isar der TU Munchen
Munchen, Germany
Praxis fur Hamatologie und Internnistische Onkologie
Velbert, Germany, 42551
Schwerpunktspraxis und Tagesklinik Dr. Perker/Dr. Sandherr
Weilheim, Germany
Israel
Rambam Medical Center
Haifa, Israel
Shaare-Zedek Medical Centre
Jerusalem, Israel, 91031
Rabin Medical Center, Beilinson Hospital
Petah Tiqva, Israel, 49100
Sheba Medical Center
Ramat Gan, Israel, 52621
TA Sourasky Medical Center
Tel Aviv, Israel, 64239
Italy
A.O.U. die Bologna
Bologna, Italy, 40138
New Zealand
University of Auckland
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Dunedin Hospital
Dunedin, New Zealand
Wellington Hospital
Newtown, New Zealand
Palmerston North Hospital
Palmerston, New Zealand
Poland
Wojskowy Instytut Medyczny (WIM)
Warsaw, Poland, 04-141
Spain
Clinica Universitaria de Navarra
Pamplona, Spain, 31008
Hospital de Navarra, Servicio de Ongoligia, Planta Baja
Pamplona, Spain, 31008
Switzerland
Universitatsspital Zurich
Zurich, Switzerland, CH-8091
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 27, 2014
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:
Neoplasm Metastasis
Colorectal Neoplasms
Liver Neoplasms
Carcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
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 September 22, 2014