Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer

Conditions

• Colorectal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• sunitinib — DRUG
  Sunitinib: 37.5 mg/day, oral, administered on an outpatient basis for 4 weeks on, 2 weeks off (Schedule 4/2).
• mFOLFOX6 — DRUG
  FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle
• bevacizumab — DRUG
  Bevacizumab: 5 mg/kg, IV infusion, every 2 weeks.
• mFOLFOX6 — DRUG
  FOLFOX will be administered every 2 weeks, using the modified FOLFOX6 (mFOLFOX6) regimen, consisting of: - oxaliplatin 85 mg/ m\^2 + leucovorin 400 mg/ m\^2 (or 200 mg/ m\^2 levo-leucovorin) as a 2-hr IV infusion followed by 5-fluorouracil 400 mg/ m\^2 IV bolus on day 1 and 5-fluorouracil 2400 mg/ m\^2 IV infusion over 46 hours on Days 1 and 2 of each 2 week cycle

Study Details

This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer who have not been treated before.

Key Dates

First listed

Feb 7, 2008

Start date

Apr 30, 2008

Status verified

Sep 2012

Primary completion

Jul 31, 2011

Completion

Jul 31, 2011

Study Design

Enrollment

191 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: A
  Treatment arm A - sunitinib plus mFOLFOX6
• Active Comparator: B
  Treatment arm B - bevacizumab plus mFOLFOX6

Primary Outcome Measure

Progression-free Survival (PFS) [ Time Frame: Baseline, at every 8-week intervals for 18 months then every 12 weeks thereafter until disease progression (up to Week 115) ]

Locations (81)

Find similar trials in Fairhope, AL

Related Studies

• Obtaining Solid Tumor Tissue From People Having Biopsy or Surgery for Certain Types of Cancer
  Recruiting · National Cancer Institute (NCI) · Bethesda, Maryland
• Performance of SGM-101 for the Delineation of Primary and Recurrent Tumor and Metastases in Patients Undergoing Surgery for Colorectal Cancer
  PHASE3 · Recruiting · Surgimab · Duarte, California
• Metarrestin (ML-246) in Subjects With Metastatic Solid Tumors
  PHASE1 · Recruiting · National Cancer Institute (NCI) · Fairway, Kansas
• A Study of Tucatinib With Trastuzumab and mFOLFOX6 Versus Standard of Care Treatment in First-line HER2+ Metastatic Colorectal Cancer
  PHASE3 · Recruiting · Seagen, a wholly owned subsidiary of Pfizer · Glendale, Arizona