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
- Anal, Colon, and Rectal Cancers
- Colon/Rectal Cancer
- Colorectal Neoplasms
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Vandetanib — DRUG100mg or 300mg By mouth every day continuous
- Capecitabine — DRUGDosage: 1000mg/m2 By mouth twice a day for 14 days or reduced dose of 800mg/m2 PO BID days1-14.
- Oxaliplatin — DRUGdosage: 130mg/m2. IV Day 1 of a 21 day cycle or reduced dose of 100mg/m2 IV Day 1.
- Bevacizumab — DRUGDosage: 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)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | - |
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