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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00735241
Other study ID # STX0207
Secondary ID
Status Withdrawn
Phase Phase 2/Phase 3
First received August 13, 2008
Last updated May 21, 2015
Start date July 2008
Est. completion date March 2009

Study information

Verified date May 2015
Source Sirtex Medical
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 2009
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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).

Study Design

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


Intervention

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
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
Bevacizumab cycles 3 onwards
Bevacizumab 10 mg/m2, IV infusion, q 2 weeks commencing with the third cycle of chemotherapy

Locations

Country Name City State
United States Carolinas Medical Center Charlotte North Carolina
United States William Beaumont Hospital Royal Oak Michigan
United States Sacred Heart Medical Center Spokane Washington

Sponsors (1)

Lead Sponsor Collaborator
Sirtex Medical

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Toxicity and safety from study entry until 28 days after last cycle of chemotherapy Yes
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