S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy

Sponsor
SWOG Cancer Research Network
Study ID
NCT00066612
Phase
PHASE2
Status
Completed

Conditions

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer

Eligibility Criteria

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

Interventions

  • irinotecan hydrochloride — DRUG
    Irinotecan will be given 250 mg/m\^2 through intravenous (IV) for 90 minutes on day 1 for every 21 days until tumor progression or unacceptable toxicity or other reason for discontinuation occurs

Study Details

RATIONALE: Drugs used in chemotherapy such as irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who have recurrent or refractory advanced transitional cell cancer of the urothelium.

Key Dates

Start date
Jul 31, 2003
Status verified
Oct 2012
Primary completion
Aug 31, 2007
Completion
May 31, 2010

Study Design

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

Arms

  • Experimental: Treatment
    Irinotecan

Primary Outcome Measure

Probability of response (confirmed complete and partial response) [ Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years ]

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