Irinotecan and 3-AP in Treating Patients With Metastatic or Unresectable Solid Tumors

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT00084877
Phase
PHASE1
Status
Completed

Conditions

  • Unspecified Adult Solid Tumor, Protocol Specific

Eligibility Criteria

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

Interventions

  • triapine — DRUG
    Given IV
  • irinotecan hydrochloride — DRUG
    Given IV
  • laboratory biomarker analysis — OTHER
    Correlative studies
  • pharmacological study — OTHER
    Correlative studies

Study Details

This phase I trial is studying the side effects and best dose of irinotecan and 3-AP in treating patients with metastatic or unresectable solid tumors. Drugs used in chemotherapy such as irinotecan work in different ways to stop tumor cells from dividing so they stop growing or die. 3-AP may stop the growth of tumor cells by blocking the enzymes necessary for their growth and may help irinotecan kill more tumor cells by making them more sensitive to the drug.

Key Dates

Start date
Mar 31, 2004
Status verified
May 2013
Primary completion
Jul 31, 2008

Study Design

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

Arms

  • Experimental: Treatment (triapine, irinotecan hydrochloride)
    Patients receive irinotecan IV over 1 hour on day 1 and 3-AP (Triapine®) IV over 2 hours on days 1-3. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of irinotecan and 3-AP (Triapine®) until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, 6 additional patients are treated at that dose.

Primary Outcome Measure

Number and severity of toxicity incidents categorized via CTC standard toxicity grading [ Time Frame: Up to 4 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Madison, WI

By research site
University of Wisconsin Hospital and Clinics· Madison, WI

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