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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 2/Phase 3
18 Years
N/A
Not Enrolling
Both
Colorectal Carcinoma, Liver Metastases

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Trial Information

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


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).

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Toxicity and safety

Outcome Time Frame:

from study entry until 28 days after last cycle of chemotherapy

Safety Issue:

Yes

Principal Investigator

Dennis Carter, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rocky Mountain Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

STX0207

NCT ID:

NCT00735241

Start Date:

July 2008

Completion Date:

March 2009

Related Keywords:

  • Colorectal Carcinoma
  • Liver Metastases
  • colon cancer
  • colorectal cancer
  • liver metastases
  • SIR-Spheres Microspheres
  • yttrium-90
  • FOLFOX
  • Bevacizumab
  • chemo-radiation
  • Carcinoma
  • Colorectal Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Liver Neoplasms

Name

Location

William Beaumont HospitalRoyal Oak, Michigan  48073
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Sacred Heart Medical CenterSpokane, Washington  99204