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

NCT00735241 | Withdrawn Phase 2 DMC

• 1 other identifier: STX0207
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Colorectal Carcinoma; Liver Metastases

Keywords

colon cancer; colorectal cancer; liver metastases; SIR-Spheres Microspheres; yttrium-90; FOLFOX; Bevacizumab; chemo-radiation

Outcome Measures

Primary Outcomes (1)

• Toxicity and safety

  from study entry until 28 days after last cycle of chemotherapy

Interventions

SIR-Spheres microspheres DEVICE

SIR-Spheres yttrium-90 microspheres

FOLFOX6 cycles 1-3 DRUG

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

Also known as: Eloxatin, Folinic acid, 5-FU

FOLFOX6 cycles 4 onwards DRUG

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

Also known as: Eloxatin, Folinic acid, 5-FU

Bevacizumab cycles 3 onwards DRUG

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

Also known as: Avastin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sirtex Medical: lead

Study Sites (3)

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28208, United States

Location

Sacred Heart Medical Center

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms

Interventions

Oxaliplatin; Leucovorin; Fluorouracil; Bevacizumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Dennis Carter, MD

  Rocky Mountain Cancer Center

  PRINCIPAL INVESTIGATOR

• Charlie Nutting, DO

  Skye Ridge Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 13, 2008
• First Posted: August 14, 2008
• Study Start: July 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 22, 2015

Record last verified: 2015-05

Locations

US (3)