ZD6474, Cetuximab, and Irinotecan in Patients With Metastatic Colorectal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT00436072
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ZD6474 — DRUG
    Orally on a daily basis
  • Cetuximab — DRUG
    Infusion once weekly
  • Irinotecan — DRUG
    Infusion once the safe dose of ZD6474 and cetuximab is established

Study Details

This research study will test the safety of the investigational drug, ZD6474, in combination with 2 other drugs that are standard in the treatment of colon and rectal cancer (cetuximab and irinotecan). ZD6474 blocks the action of two substances in the body: vascular endothelial growth factor receptor (VEGFR) and epidermal growth factor receptor (EGFR). VEGFR stimulates the formation of new blood vessels. When cancer cells produce VEGFR, new blood vessels are made that provide blood to the cancer cells. The blood carries nutrients and oxygen, allowing the cancer cells to live and grow. EGFR controls how quickly cells grow and multiply. Both of these substances are found on normal cells, but they are found in much higher levels on cancer cells.

Key Dates

Start date
Feb 28, 2007
Status verified
Oct 2012
Primary completion
Feb 29, 2012
Completion
Aug 31, 2012

Study Design

Enrollment
46 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Primary Outcome Measure

To determine the tolerability and maximum tolerated dose of combining ZD6474, cetuximab and irinotecan in patients with metastatic colorectal cancer refractory to prior cytotoxic chemotherapy. [ Time Frame: Years ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02215-

Find similar trials in Boston, MA

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Beth Israel Deaconess Medical Center· Boston, MADana-Farber Cancer Institute· Boston, MAMassachusetts General Hospital· Boston, MA

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