Combination of Cetuximab, Capecitabine, and Oxaliplatin With or Without Bevacizumab

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Fox Chase Cancer Center
Study ID
NCT00321100
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • bevacizumab — DRUG
    Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
  • cetuximab — DRUG
    Cetuximab 400mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly each 21 day cycle
  • Oxaliplatin — DRUG
    Oxaliplatin 130mg/m2 IV day 1 every 21 days
  • Capecitabine — DRUG
    Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Study Details

The purpose of this study is to determine the objective response rate of patients with previously untreated metastatic colorectal cancer treated with the combination of cetuximab, capecitabine, and oxaliplatin with out without bevacizumab.

Key Dates

First listed
May 3, 2006
Start date
Apr 12, 2006
Status verified
Dec 2021
Primary completion
Apr 30, 2009
Completion
Dec 18, 2013

Study Design

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

Arms

  • Active Comparator: Cetuximab, Oxaliplatin, Capecitabine, Bevacizumab
    Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle; Bevacizumab 7.5mg/kg IV day 1 of each 21 day cycle
  • Active Comparator: Cetuximab, Oxaliplatin, Capecitabine
    Cetuximab 400 mg/m2 IV initial dose (cycle 1 day 1 only), then 250mg/m2 IV weekly of each 21 day cycle; Oxaliplatin 130mg/m2 IV day 1 of each 21 day cycle; Capecitabine 850mg/m2 PO every 12 hours days 1-14 of each 21 day cycle

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: every 6-9 weeks; from date of first study drug dose until off treatment date (median of 8 cycles; range <1-19) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-

Find similar trials in Philadelphia, PA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Fox Chase Cancer Center· Philadelphia, PA

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