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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00066612
First Posted: August 7, 2003
Last Update Posted: November 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group
  Purpose

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 Intervention Phase
Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer Drug: irinotecan hydrochloride Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 45
Study Start Date: July 2003
Study Completion Date: May 2010
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment
Irinotecan
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

Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

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


Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: Tomasz M. Beer, MD OHSU Knight Cancer Institute
  More Information

Publications:
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00066612     History of Changes
Other Study ID Numbers: CDR0000316428
U10CA032102 ( U.S. NIH Grant/Contract )
S0306 ( Other Identifier: SWOG )
First Submitted: August 6, 2003
First Posted: August 7, 2003
Last Update Posted: November 2, 2012
Last Verified: October 2012

Keywords provided by Southwest Oncology Group:
recurrent bladder cancer
stage IV bladder cancer
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
regional transitional cell cancer of the renal pelvis and ureter
transitional cell carcinoma of the bladder
anterior urethral cancer
posterior urethral cancer
recurrent urethral cancer
urethral cancer associated with invasive bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urethral Neoplasms
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Urethral Diseases
Kidney Diseases
Ureteral Diseases
Irinotecan
Camptothecin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action