SU5416 and Irinotecan in Treating Patients With Advanced Colorectal Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00005818
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Adenocarcinoma of the Colon
  • Adenocarcinoma of the Rectum
  • Recurrent Colon Cancer
  • Recurrent Rectal Cancer
  • Stage III Colon Cancer
  • Stage III Rectal Cancer
  • Stage IV Colon Cancer
  • Stage IV Rectal Cancer

Eligibility Criteria

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

Interventions

  • irinotecan hydrochloride — DRUG
    Given IV
  • semaxanib — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies

Study Details

Phase I/II trial to study the effectiveness of combining SU5416 and irinotecan in treating patients who have advanced colorectal cancer. SU5416 may stop the growth of colorectal cancer by stopping blood flow to the tumor. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die

Key Dates

Start date
Mar 31, 2000
Status verified
Jan 2013
Primary completion
Mar 31, 2003

Study Design

Enrollment
68 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (irinotecan hydrochloride, semaxanib)
    Patients receive irinotecan IV over 90 minutes on day 1 of weeks 1-4 and SU5416 IV over 60 minutes on days 1 and 4 of weeks 1-6. Treatment continues every 6 weeks in the absence of unacceptable toxicity or disease progression.

Primary Outcome Measure

Time to disease progression (TTP) [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030-

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