Trial | NCT00735241  Report issue

Title

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

  • Phase

    Phase 2/Phase 3

  • Study Type

    Interventional

  • Status

    Withdrawn

  • Study Participants

    0
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.
Study Started
Jul 31
2008
Primary Completion
Mar 31
2009
Anticipated
Study Completion
Mar 31
2009
Anticipated
Last Update
May 22
2015
Estimate

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

Device SIR-Spheres microspheres

SIR-Spheres yttrium-90 microspheres

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 names: Avastin

Criteria 

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).
No Results Posted