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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
Sponsor:
Collaborator:
Information provided by (Responsible Party):

August 6, 2003
August 7, 2003
November 2, 2012
July 2003
August 2007   (Final data collection date for 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 ]
Not Provided
Complete list of historical versions of study NCT00066612 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy
Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium

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.

OBJECTIVES:

  • 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.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
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
Experimental: Treatment
Irinotecan
Intervention: Drug: irinotecan hydrochloride
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
May 2010
August 2007   (Final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed transitional cell carcinoma (TCC) of the urothelium, including the bladder, renal pelvis, ureter, and urethra

    • Stage T2-4, N0-3, M1 OR stage T2-4, N+, M0, unresectable disease
    • The following additional histologic subtypes are eligible:

      • Poorly differentiated TCC
      • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00066612
CDR0000316428
U10CA032102 ( U.S. NIH Grant/Contract )
S0306 ( Other Identifier: SWOG )
Yes
Not Provided
Not Provided
Southwest Oncology Group
Southwest Oncology Group
National Cancer Institute (NCI)
Study Chair: Tomasz M. Beer, MD OHSU Knight Cancer Institute
Southwest Oncology Group
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP