A Study Combining FOLFOX or FOLFIRI With AG-013736 or Bevacizumab (Avastin) in Patients With Metastatic Colorectal Cancer After Failure Of One First Line Regimen

Conditions

• Colorectal Neoplasms

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Bevacizumab (avastin) — DRUG
  Bevacizumab intravenous \[IV\] infusion 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
• FOLFIRI (Irinotecan, leucovorin, 5-fluorouracil [5FU]) — DRUG
  Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) intravenous \[IV\] and a subsequent 5-FU infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
• AG-013736 (axitinib) — DRUG
  Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.
• FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) — DRUG
  Oxaliplatin (85 mg/m²) intravenous infusion \[IV\] over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
• AG-013736 (axitinib) — DRUG
  Axitinib is given at a starting dose of 5 mg twice daily \[BID\] continuous dosing until disease progression, intolerance or withdrawal of consent.
• FOLFIRI (irinotecan, leucovorin, 5-fluorouracil [5FU]) — DRUG
  Irinotecan (180 mg/m²) intravenous infusion \[IV\] over 90 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed immediately by 5-FU bolus (400 mg/m²) IV and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.
• Bevacizumab (avastin) — DRUG
  Bevacizumab intravenous infusion \[IV\] 5 mg/kg every two weeks until disease progression, intolerance or withdrawal of consent.
• FOLFOX (oxaliplatin, leucovorin, 5-fluorouracil [5FU]) — DRUG
  Oxaliplatin (85 mg/m²) IV infusion over 120 minutes, concurrently with leucovorin (400 mg/m²) intravenous infusion \[IV\] over 2 hours followed by 5-FU IV bolus (400 mg/m²) and a subsequent 5-FU IV infusion (2400 mg/m² over 46-48 hours), repeated every 2 weeks until disease progression, intolerance or withdrawal of consent.

Study Details

The study is designed to demonstrate that the combination of AG-013736 with either FOLFIRI or FOLFOX is superior to FOLFIRI or FOLFOX in combination with bevacizumab (Avastin) in delaying tumor progression in the second-line treatment of patients with metastatic colorectal cancer after failure of an irinotecan or oxaliplatin-containing first-line regimen.

Key Dates

Start date

Mar 31, 2008

Status verified

Apr 2013

Primary completion

Mar 31, 2011

Completion

Apr 30, 2012

Study Design

Enrollment

171 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: B
  Bevacizumab (avastin)
• Experimental: C
  AG-013736 (axitinib)
• Experimental: A
  AG-013736 (axitinib)
• Active Comparator: D
  bevacizumab (avastin)

Primary Outcome Measure

Progression Free Survival (PFS) [ Time Frame: Baseline until disease progression or discontinuation from the study due to any cause, assessed every 8 week up to 130 weeks ]

Locations (61)

Find similar trials in Mobile, 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