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

This study has been withdrawn prior to enrollment.
(Withdrawn by the study sponsor.)
Sponsor:
Information provided by:
Sirtex Medical
ClinicalTrials.gov Identifier:
NCT00735241
First received: August 13, 2008
Last updated: March 24, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention Phase
Colorectal Carcinoma
Liver Metastases
Device: SIR-Spheres microspheres
Drug: FOLFOX6 cycles 1-3
Drug: FOLFOX6 cycles 4 onwards
Drug: Bevacizumab cycles 3 onwards
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Sirtex Medical:

Primary Outcome Measures:
  • Toxicity and safety [ Time Frame: from study entry until 28 days after last cycle of chemotherapy ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: July 2008
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  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: NCT00735241

Locations
United States, Michigan
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28208
United States, Washington
Sacred Heart Medical Center
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Sirtex Medical
Investigators
Principal Investigator: Dennis Carter, MD Rocky Mountain Cancer Center
Principal Investigator: Charlie Nutting, DO Skye Ridge Medical Center
  More Information

No publications provided

Responsible Party: David Cade, MD, Medical Director, Sirtex Technology Pty Ltd
ClinicalTrials.gov Identifier: NCT00735241     History of Changes
Other Study ID Numbers: STX0207
Study First Received: August 13, 2008
Last Updated: March 24, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Sirtex Medical:
colon cancer
colorectal cancer
liver metastases
SIR-Spheres Microspheres
yttrium-90
FOLFOX
Bevacizumab
chemo-radiation

Additional relevant MeSH terms:
Carcinoma
Colorectal Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
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
Leucovorin
Folic Acid
Bevacizumab
Levoleucovorin
Oxaliplatin
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 31, 2014