Southwest Oncology Group phase II study of irinotecan in patients with advanced transitional cell carcinoma of the urothelium that progressed after platinum-based chemotherapy

Tomasz (Tom) Beer, Bryan Goldman, Craig R. Nichols, Daniel P. Petrylak, Manoj Agarwal, Christopher Ryan, E. David Crawford

    Research output: Contribution to journalArticle

    24 Citations (Scopus)

    Abstract

    Purpose: The purpose of this study was to characterize the activity and toxicity of irinotecan in metastatic platinum-refractory urothelial carcinoma. Patients and Methods: In a prospective multi-institutional phase II clinical trial, we evaluated the activity and safety of irinotecan 350 mg/m2 (300 mg/m2 in patients with previous radiation therapy to the pelvis) intravenously given every 21 days in patients with metastatic urothelial carcinoma and evidence of progression following one previous systemic chemotherapy regimen for metastatic disease that included cisplatin or carboplatin. The primary goal of this study was to evaluate the probability of confirmed complete or partial response. Results: Forty eligible patients were registered between December 2003 and December 2006. One patient had a complete response, and 1 had a partial response (overall response rate, 5%; 95% CI, 1%-17%). Median progression-free survival was 2.1 months (95% CI, 1.8-2.3 months). Median overall survival was 5.4 months (95% CI, 3.4-7.1 months). Toxicity was similar to that reported previously for this schedule of irinotecan. Conclusion: The response rate seen in this study is insufficient to recommend further evaluation of irinotecan in urothelial cancer that relapsed following initial platinum-based chemotherapy. Investigation of novel agents for this patient population remains a priority.

    Original languageEnglish (US)
    Pages (from-to)36-39
    Number of pages4
    JournalClinical Genitourinary Cancer
    Volume6
    Issue number1
    DOIs
    StatePublished - Mar 2008

    Fingerprint

    irinotecan
    Urothelium
    Transitional Cell Carcinoma
    Platinum
    Drug Therapy
    Carcinoma
    Phase II Clinical Trials
    Carboplatin
    Proxy
    Pelvis
    Cisplatin
    Disease-Free Survival
    Appointments and Schedules
    Radiotherapy
    Safety

    Keywords

    • Carboplatin
    • Cisplatin
    • Metastasis

    ASJC Scopus subject areas

    • Oncology
    • Urology

    Cite this

    Southwest Oncology Group phase II study of irinotecan in patients with advanced transitional cell carcinoma of the urothelium that progressed after platinum-based chemotherapy. / Beer, Tomasz (Tom); Goldman, Bryan; Nichols, Craig R.; Petrylak, Daniel P.; Agarwal, Manoj; Ryan, Christopher; Crawford, E. David.

    In: Clinical Genitourinary Cancer, Vol. 6, No. 1, 03.2008, p. 36-39.

    Research output: Contribution to journalArticle

    @article{e73d8c5a71a64de4a0fd165e7c1b8b6c,
    title = "Southwest Oncology Group phase II study of irinotecan in patients with advanced transitional cell carcinoma of the urothelium that progressed after platinum-based chemotherapy",
    abstract = "Purpose: The purpose of this study was to characterize the activity and toxicity of irinotecan in metastatic platinum-refractory urothelial carcinoma. Patients and Methods: In a prospective multi-institutional phase II clinical trial, we evaluated the activity and safety of irinotecan 350 mg/m2 (300 mg/m2 in patients with previous radiation therapy to the pelvis) intravenously given every 21 days in patients with metastatic urothelial carcinoma and evidence of progression following one previous systemic chemotherapy regimen for metastatic disease that included cisplatin or carboplatin. The primary goal of this study was to evaluate the probability of confirmed complete or partial response. Results: Forty eligible patients were registered between December 2003 and December 2006. One patient had a complete response, and 1 had a partial response (overall response rate, 5{\%}; 95{\%} CI, 1{\%}-17{\%}). Median progression-free survival was 2.1 months (95{\%} CI, 1.8-2.3 months). Median overall survival was 5.4 months (95{\%} CI, 3.4-7.1 months). Toxicity was similar to that reported previously for this schedule of irinotecan. Conclusion: The response rate seen in this study is insufficient to recommend further evaluation of irinotecan in urothelial cancer that relapsed following initial platinum-based chemotherapy. Investigation of novel agents for this patient population remains a priority.",
    keywords = "Carboplatin, Cisplatin, Metastasis",
    author = "Beer, {Tomasz (Tom)} and Bryan Goldman and Nichols, {Craig R.} and Petrylak, {Daniel P.} and Manoj Agarwal and Christopher Ryan and Crawford, {E. David}",
    year = "2008",
    month = "3",
    doi = "10.3816/CGC.2008.n.006",
    language = "English (US)",
    volume = "6",
    pages = "36--39",
    journal = "Clinical Genitourinary Cancer",
    issn = "1558-7673",
    publisher = "Elsevier",
    number = "1",

    }

    TY - JOUR

    T1 - Southwest Oncology Group phase II study of irinotecan in patients with advanced transitional cell carcinoma of the urothelium that progressed after platinum-based chemotherapy

    AU - Beer, Tomasz (Tom)

    AU - Goldman, Bryan

    AU - Nichols, Craig R.

    AU - Petrylak, Daniel P.

    AU - Agarwal, Manoj

    AU - Ryan, Christopher

    AU - Crawford, E. David

    PY - 2008/3

    Y1 - 2008/3

    N2 - Purpose: The purpose of this study was to characterize the activity and toxicity of irinotecan in metastatic platinum-refractory urothelial carcinoma. Patients and Methods: In a prospective multi-institutional phase II clinical trial, we evaluated the activity and safety of irinotecan 350 mg/m2 (300 mg/m2 in patients with previous radiation therapy to the pelvis) intravenously given every 21 days in patients with metastatic urothelial carcinoma and evidence of progression following one previous systemic chemotherapy regimen for metastatic disease that included cisplatin or carboplatin. The primary goal of this study was to evaluate the probability of confirmed complete or partial response. Results: Forty eligible patients were registered between December 2003 and December 2006. One patient had a complete response, and 1 had a partial response (overall response rate, 5%; 95% CI, 1%-17%). Median progression-free survival was 2.1 months (95% CI, 1.8-2.3 months). Median overall survival was 5.4 months (95% CI, 3.4-7.1 months). Toxicity was similar to that reported previously for this schedule of irinotecan. Conclusion: The response rate seen in this study is insufficient to recommend further evaluation of irinotecan in urothelial cancer that relapsed following initial platinum-based chemotherapy. Investigation of novel agents for this patient population remains a priority.

    AB - Purpose: The purpose of this study was to characterize the activity and toxicity of irinotecan in metastatic platinum-refractory urothelial carcinoma. Patients and Methods: In a prospective multi-institutional phase II clinical trial, we evaluated the activity and safety of irinotecan 350 mg/m2 (300 mg/m2 in patients with previous radiation therapy to the pelvis) intravenously given every 21 days in patients with metastatic urothelial carcinoma and evidence of progression following one previous systemic chemotherapy regimen for metastatic disease that included cisplatin or carboplatin. The primary goal of this study was to evaluate the probability of confirmed complete or partial response. Results: Forty eligible patients were registered between December 2003 and December 2006. One patient had a complete response, and 1 had a partial response (overall response rate, 5%; 95% CI, 1%-17%). Median progression-free survival was 2.1 months (95% CI, 1.8-2.3 months). Median overall survival was 5.4 months (95% CI, 3.4-7.1 months). Toxicity was similar to that reported previously for this schedule of irinotecan. Conclusion: The response rate seen in this study is insufficient to recommend further evaluation of irinotecan in urothelial cancer that relapsed following initial platinum-based chemotherapy. Investigation of novel agents for this patient population remains a priority.

    KW - Carboplatin

    KW - Cisplatin

    KW - Metastasis

    UR - http://www.scopus.com/inward/record.url?scp=43249131172&partnerID=8YFLogxK

    UR - http://www.scopus.com/inward/citedby.url?scp=43249131172&partnerID=8YFLogxK

    U2 - 10.3816/CGC.2008.n.006

    DO - 10.3816/CGC.2008.n.006

    M3 - Article

    C2 - 18501081

    AN - SCOPUS:43249131172

    VL - 6

    SP - 36

    EP - 39

    JO - Clinical Genitourinary Cancer

    JF - Clinical Genitourinary Cancer

    SN - 1558-7673

    IS - 1

    ER -