search
Back to results

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

Primary Purpose

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

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
irinotecan hydrochloride
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Treatment

    Arm Description

    Irinotecan

    Outcomes

    Primary Outcome Measures

    Probability of response (confirmed complete and partial response)

    Secondary Outcome Measures

    Number and grade of adverse events
    Overall survival
    Progression-free survival

    Full Information

    First Posted
    August 6, 2003
    Last Updated
    October 31, 2012
    Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT00066612
    Brief Title
    S0306, Irinotecan in Treating Patients With Recurrent or Refractory Advanced Transitional Cell Cancer of the Urothelium Previously Treated With Chemotherapy
    Official Title
    Phase II Study of Irinotecan in Patients With Advanced Transitional Cell Carcinoma of the Urothelium
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    July 2003 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    May 2010 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    SWOG Cancer Research Network
    Collaborators
    National Cancer Institute (NCI)

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
    Keywords
    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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    45 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment
    Arm Type
    Experimental
    Arm Description
    Irinotecan
    Intervention Type
    Drug
    Intervention Name(s)
    irinotecan hydrochloride
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Tomasz M. Beer, MD
    Organizational Affiliation
    OHSU Knight Cancer Institute
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    18501081
    Citation
    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.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs