Irinotecan (Camptosar) in Patients With Advanced Sarcomas

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT00509860
Phase
PHASE2
Status
Completed

Conditions

  • Sarcoma

Eligibility Criteria

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

Interventions

  • Irinotecan — DRUG
    16 mg/m2 by vein Daily Over 1 Hour x 5 Days

Study Details

Primary Objectives: 1. To determine the efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma. 2. To determine the toxicity profile of irinotecan, using a protracted schedule, in this pretreated patient population.

Key Dates

Start date
Mar 31, 2003
Status verified
Dec 2012
Primary completion
Aug 31, 2007
Completion
Jan 31, 2012

Study Design

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

Arms

  • Experimental: Irinotecan
    Irinotecan 16 mg/m2 by vein daily over 1 hour for 5 Days

Primary Outcome Measure

Efficacy of the topoisomerase I (topo I) inhibitor irinotecan, delivered via a low-dose protracted schedule to patients with advanced sarcoma [ Time Frame: Four 3-week cycles (12 weeks) ]

Locations (1)

FacilityCityStateZIPSite coordinators
UT MD Anderson Cancer CenterHoustonTexas77030-

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