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

Liver Metastases Clinical Trial

— FAST  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00735241
• Other study ID #: STX0207
• Status: Withdrawn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• Status: Withdrawn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

Related Conditions & MeSH terms

• Carcinoma
• Colorectal Carcinoma
• Colorectal Neoplasms
• Liver Metastases
• Liver Neoplasms
• Neoplasm Metastasis

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