Study of Bevacizumab Combined With Capecitabine and Either Oxaliplatin or Irinotecan as First Course of Treatment for Patients With Colorectal Cancer That Has Spread Beyond the Colon

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
NSABP Foundation Inc
Study ID
NCT00314353
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    7.5 mg/kg IV Day 1 every 21 days for eight cycles\* \*For patients with stable or responding disease after 8 cycles, continue bevacizumab at the same dose levels until disease progression.
  • Oxaliplatin — DRUG
    130 mg/m2 IV Day 1 every 21 days for eight cycles
  • Capecitabine — DRUG
    850 mg/m2 po BID Days 1-14 every 21 days for eight cycles\*# \*For patients with stable or responding disease after 8 cycles, continue capecitabine at the same dose levels until disease progression. #For patients with baseline calculated creatinine clearance of 30-50 mL/min, the starting dose will be reduced to 650 mg/m2 BID
  • Irinotecan — DRUG
    200 mg/m2 IV Day 1 every 21 days for eight cycles

Study Details

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy works to kill cancer cells directly. This study is being done to see how colorectal cancer responds to treatment with the combination of bevacizumab and chemotherapy.

Key Dates

Start date
Mar 31, 2006
Status verified
Oct 2021
Primary completion
May 31, 2008
Completion
Jun 30, 2010

Study Design

Enrollment
7 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 1
  • Experimental: 2

Primary Outcome Measure

One-year Progression-free Survival (PFS) [ Time Frame: Unevaluable - accrual ended early due to slow accrual rate and before accrual goal was met. ]

Locations (1)

FacilityCityStateZIPSite coordinators
NSABP Operations CenterPittsburghPennsylvania15212-

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