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

Last updated: May 21, 2015
Sponsor: Sirtex Medical
Overall Status: Trial Not Available

Phase

2/3

Condition

Neoplasm Metastasis

Carcinoma

Digestive System Neoplasms

Treatment

N/A

Clinical Study ID

NCT00735241
STX0207
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma of the colon or rectum.

  • Unequivocal and measurable CT evidence of liver metastases which are not treatable bysurgical resection or local ablation with curative intent.

  • ECOG performance status 0 - 1.

  • Adequate hematological, renal and hepatic function.

Exclusion

Exclusion Criteria:

  • Evidence of ascites, cirrhosis, portal hypertension, main portal vein tumorinvolvement or thrombosis as determined by clinical or radiologic assessment.

  • Any extra-hepatic metastases other than metastases in the lungs and/or bones and/orabdominal or hilar lymph nodes. Central nervous system (CNS) metastases are notallowed.

  • Previous radiotherapy delivered to the upper abdomen.

  • Peripheral neuropathy > grade 1 (NCI-CTCv3).

Study Design

Study Start date:
July 01, 2008
Estimated Completion Date:
March 31, 2009

Connect with a study center

  • William Beaumont Hospital

    Royal Oak, Michigan 48073
    United States

    Site Not Available

  • Carolinas Medical Center

    Charlotte, North Carolina 28208
    United States

    Site Not Available

  • Sacred Heart Medical Center

    Spokane, Washington 99204
    United States

    Site Not Available

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