S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy
NCT ID: NCT00066612
Last Updated: 2012-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
45 participants
INTERVENTIONAL
2003-07-31
2010-05-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment
Irinotecan
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* Predominant TCC with rare foci of squamous differentiation
* Predominant TCC with rare foci of adenocarcinoma
* The following histologic subtypes are ineligible:
* Adenocarcinoma
* Small cell carcinoma
* Sarcoma
* Squamous cell carcinoma
* Mixed adeno/squamous/transitional histology
* Incurable by surgery or radiotherapy
* Progressed or recurred after 1, and only 1, prior cisplatin- or carboplatin-containing systemic regimen for metastatic disease
* Measurable disease
* Soft tissue disease that has been irradiated within the past 2 months is not considered measurable disease
* No uncontrolled central nervous system (CNS) metastases
* CNS metastases that have responded to or stabilized after prior radiotherapy are allowed
PATIENT CHARACTERISTICS:
Age
* 18 and over
Performance status
* Zubrod 0-2
Life expectancy
* Not specified
Hematopoietic
* Absolute granulocyte count at least 1,200/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin less than 1.5 times upper limit of normal (ULN)
* Aspartate aminotransferase (SGOT) less than 3 times ULN (5 times ULN if liver metastases are present)
Renal
* Creatinine less than 2 times ULN
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is currently in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* See Disease Characteristics
* At least 28 days since prior chemotherapy
* No prior topoisomerase I inhibitors (e.g., irinotecan or topotecan)
Endocrine therapy
* Not specified
Radiotherapy
* See Disease Characteristics
* At least 28 days since prior radiotherapy to the pelvis
Surgery
* Not specified
Other
* Recovered from prior therapy
* Prior adjuvant therapy allowed
* At least 14 days since prior Hypericum perforatum (St. John's Wort)
* More than 7 days since prior phenytoin, phenobarbital, carbamazepine, or any other enzyme-inducing anticonvulsant drugs (EIACDs)
* No St. John's Wort during and for 7 days after study participation
* No concurrent EIACDs
* No concurrent medications that cause myelosuppression
* No concurrent medications that cause diarrhea
* Concurrent gabapentin or other non-EIACDs are allowed
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
SWOG Cancer Research Network
NETWORK
Responsible Party
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Principal Investigators
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Tomasz M. Beer, MD
Role: STUDY_CHAIR
OHSU Knight Cancer Institute
Countries
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References
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Beer TM, Goldman B, Nichols CR, Petrylak DP, Agarwal M, Ryan CW, Crawford ED; Southwest Oncology Group. Southwest Oncology Group phase II study of irinotecan in patients with advanced transitional cell carcinoma of the urothelium that progressed after platinum-based chemotherapy. Clin Genitourin Cancer. 2008 Mar;6(1):36-9. doi: 10.3816/cgc.2008.n.006.
Other Identifiers
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S0306
Identifier Type: OTHER
Identifier Source: secondary_id
CDR0000316428
Identifier Type: -
Identifier Source: org_study_id