Phase I Vandetanib Plus Capecitabine, Oxaliplatin and Bevacizumab for Metastatic Colorectal Cancer

Part of paid clinical trials in Stanford, California.

Sponsor
Branimir Sikic
Study ID
NCT00532909
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Vandetanib — DRUG
    100mg or 300mg By mouth every day continuous
  • Capecitabine — DRUG
    Dosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14.
  • Oxaliplatin — DRUG
    dosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1.
  • Bevacizumab — DRUG
    Dosage: 7.5mg/kg or 10mg/kg. IV Day 1 (21 day cycle)

Study Details

To determine the maximum tolerated dose of Vandetanib with a current standard first-line chemotherapy regimen, capecitabine and oxaliplatin without and then with bevacizumab for the first line treatment of metastatic colorectal cancer (CRC) and to define the dose limiting toxicities associated with the combination.

Key Dates

First listed
Sep 21, 2007
Start date
Jul 31, 2006
Status verified
Jul 2012
Primary completion
May 31, 2010
Completion
May 31, 2010

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

Maximum tolerated dose of vandetanib in combination with capecitabine, oxaliplatin and bevacizumab [ Time Frame: Following treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford University School of MedicineStanfordCalifornia94305-

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