S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy
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|ClinicalTrials.gov Identifier: NCT00066612|
Recruitment Status : Completed
First Posted : August 7, 2003
Last Update Posted : November 2, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer||Drug: irinotecan hydrochloride||Phase 2|
- Determine the probability of response (confirmed complete and partial response) to treatment with irinotecan in patients with recurrent or refractory advanced transitional cell carcinoma of the urothelium previously treated with platinum-based chemotherapy.
- Determine the qualitative and quantitative toxic effects of this drug in these patients.
- Determine the overall and progression-free survival of patients treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior pelvic radiotherapy (yes vs no).
Patients receive irinotecan IV over 90 minutes on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 20-40 patients will be accrued for this study within 5-10 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||45 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium|
|Study Start Date :||July 2003|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||May 2010|
Drug: irinotecan hydrochloride
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
- 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 ]
- Number and grade of adverse events [ Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years ]
- Overall survival [ Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years ]
- Progression-free survival [ Time Frame: From date of registration to date of progression or death from any cause, whichever came first, assessed up to 3 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066612
|Study Chair:||Tomasz M. Beer, MD||OHSU Knight Cancer Institute|