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Trial record 22 of 46 for:    SIR-Spheres

FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma (FAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00735241
Recruitment Status : Withdrawn (Withdrawn by the study sponsor.)
First Posted : August 14, 2008
Last Update Posted : May 22, 2015
Sponsor:
Information provided by:
Sirtex Medical

Tracking Information
First Submitted Date  ICMJE August 13, 2008
First Posted Date  ICMJE August 14, 2008
Last Update Posted Date May 22, 2015
Study Start Date  ICMJE July 2008
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 13, 2008)
Toxicity and safety [ Time Frame: from study entry until 28 days after last cycle of chemotherapy ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00735241 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE FOLFOX6 Plus Sir-Spheres Microspheres Plus Avastin in Patients With Nonresectable Liver Metastases From Colorectal Carcinoma
Official Title  ICMJE Pilot Study of FOLFOX6 Plus Sir-Spheres® Microspheres (Chemo-radiotherapy) in Combination With Bevacizumab (Avastin) as a First Line Treatment in Patients With Nonresectable Liver Metastases From Primary Colorectal Carcinoma
Brief Summary This pilot study will evaluate the safety and effectiveness of chemo-radiotherapy comprising a regimen of FOLFOX6 chemotherapy plus SIR-Spheres yttrium-90 microspheres (chemo-radiotherapy, also known as "chemo-SIRT"), in combination with the biologic therapy Bevacizumab (Avastin), for the first-line treatment of patients with liver metastases from colorectal carcinoma in whom surgical resection is not feasible.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Colorectal Carcinoma
  • Liver Metastases
Intervention  ICMJE
  • Device: SIR-Spheres microspheres
    SIR-Spheres yttrium-90 microspheres
  • Drug: FOLFOX6 cycles 1-3
    Oxaliplatin 60 mg/m2, IV infusion, q 2 weeks Leucovorin 200 mg/m2, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks
    Other Names:
    • Eloxatin
    • Folinic acid
    • 5-FU
  • Drug: FOLFOX6 cycles 4 onwards
    Oxaliplatin 85 mg/m2 given, IV infusion, q 2 weeks Leucovorin 200 mg/m2 given, IV infusion, q 2 weeks 5-Fluorouracil 400 mg/m2, IV bolus, q 2 weeks 5-Fluorouracil 2.4 g/m2, IV infusion, q 2 weeks
    Other Names:
    • Eloxatin
    • Folinic acid
    • 5-FU
  • Drug: Bevacizumab cycles 3 onwards
    Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy
    Other Name: Avastin
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: May 21, 2015)
0
Original Estimated Enrollment  ICMJE
 (submitted: August 13, 2008)
30
Estimated Study Completion Date  ICMJE March 2009
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the colon or rectum.
  • Unequivocal and measurable CT evidence of liver metastases which are not treatable by surgical resection or local ablation with curative intent.
  • ECOG performance status 0 - 1.
  • Adequate hematological, renal and hepatic function.

Exclusion Criteria:

  • Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumor involvement or thrombosis as determined by clinical or radiologic assessment.
  • Any extra-hepatic metastases other than metastases in the lungs and/or bones and/or abdominal or hilar lymph nodes. Central nervous system (CNS) metastases are not allowed.
  • Previous radiotherapy delivered to the upper abdomen.
  • Peripheral neuropathy > grade 1 (NCI-CTCv3).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00735241
Other Study ID Numbers  ICMJE STX0207
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party David Cade, MD, Medical Director, Sirtex Technology Pty Ltd
Study Sponsor  ICMJE Sirtex Medical
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis Carter, MD Rocky Mountain Cancer Center
Principal Investigator: Charlie Nutting, DO Skye Ridge Medical Center
PRS Account Sirtex Medical
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP