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

Part of paid clinical trials in Royal Oak, Michigan.

Sponsor
Sirtex Medical
Study ID
NCT00735241
Phase
PHASE2/PHASE3
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • SIR-Spheres microspheres — DEVICE
    SIR-Spheres yttrium-90 microspheres
  • FOLFOX6 cycles 1-3 — DRUG
    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
  • FOLFOX6 cycles 4 onwards — DRUG
    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
  • Bevacizumab cycles 3 onwards — DRUG
    Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy

Study Details

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.

Key Dates

First listed
Aug 14, 2008
Start date
Jul 31, 2008
Status verified
May 2015
Primary completion
Mar 31, 2009
Completion
Mar 31, 2009

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Toxicity and safety [ Time Frame: from study entry until 28 days after last cycle of chemotherapy ]

Locations (3)

FacilityCityStateZIPSite coordinators
William Beaumont HospitalRoyal OakMichigan48073-
Carolinas Medical CenterCharlotteNorth Carolina28208-
Sacred Heart Medical CenterSpokaneWashington99204-

Find similar trials in Royal Oak, MI

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
William Beaumont Hospital· Royal Oak, MICarolinas Medical Center· Charlotte, NCSacred Heart Medical Center· Spokane, WA

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