SU011248 in Combination With Irinotecan and Cetuximab as a Second Line Regimen for Stage IV Colorectal Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT00361244
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • SU011248 — DRUG
    Given orally in the morning for two weeks followed by a one week rest period (one cycle equals 21 days). Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
  • Irinotecan — DRUG
    Given intravenously on days 1 and 8 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.
  • Cetuximab — DRUG
    Given intravenously on days 8 and 15 of each 21-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side effects.

Study Details

The purpose of this study is to determine the safety of SU011248 and the highest dose of this drug that can be given safely in combination with the chemotherapy drugs irinotecan and cetuximab. Laboratory studies have shown that SU011248 may block the growth of blood vessels in tumors, which may prevent tumors from growing any further. Other studies have demonstrated the possibility that SU011248 may enhance the anti-tumor activity of other chemotherapy drugs such as irinotecan and cetuximab.

Key Dates

Start date
Jul 31, 2006
Status verified
Feb 2017
Primary completion
Oct 31, 2007
Completion
Aug 31, 2010

Study Design

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

Primary Outcome Measure

To determine the maximum tolerated dose of SU011248 when given in combination with irinotecan and cetuximab in patients with previously treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma [ Time Frame: 1 year ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02115-
Dana-Farber Cancer InstituteBostonMassachusetts02115-
Massachusetts General HospitalBostonMassachusetts02114-

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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