Clinical Trial: Second-Line Docetaxel + ASA404 for Advanced Urothelial Carcinoma

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A Phase II Trial of Docetaxel Plus ASA404 as Second-Line Therapy in Patients With Advanced Urothelial Carcinoma: Hoosier Oncology Group GU09-144

Brief Summary: The purpose of this study is to explore the safety and activity of docetaxel + ASA404 as second-line chemotherapy in patients with advanced urothelial carcinoma.

Detailed Summary:

OUTLINE: This is a multi-center study.

21 Day Cycle Treatment Regimen:

  • Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1
  • ASA404 (given after Docetaxel) IV 1800 mg/m2 over approximately 20 minutes on Day 1

Treatment will continue until disease progression or intolerable treatment related adverse effects.

Karnofsky performance status of ≥ 70% within 7 days prior to registration for protocol therapy.

Life Expectancy: Not specified

Hematopoietic:

  • Hemoglobin (Hgb) > 9 g/dL
  • Platelets > 100 K/mm3
  • Absolute neutrophil count (ANC) > 1.5 K/mm3
  • INR or Prothrombin Time (PT) < 1.5 x ULN

Hepatic:

  • Bilirubin < 1.5 x ULN
  • Aspartate aminotransferase (AST, ALT) < 2.5 x ULN

Renal:

  • Calculated creatinine clearance of > 45 cc/min using the Cockcroft-Gault formula

Cardiovascular:

  • No congestive heart failure (NY Heart Association class III or IV)
  • No myocardial infarction within 12 m
    Sponsor: Hoosier Cancer Research Network

    Current Primary Outcome: To determine the best overall response rate (as measured by RECIST version 1.1) of docetaxel + ASA404 as second line therapy in patients with advanced urothelial carcinoma. [ Time Frame: 12 months ]

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • To evaluate progression-free survival in patients with advanced urothelial carcinoma [ Time Frame: 12 months ]
    • To evaluate survival at 1 year from start of treatment in patients with advanced urothelial carcinoma treated with docetaxel + ASA404 as second line therapy [ Time Frame: 12 months ]
    • To evaluate the safety of docetaxel and ASA404 combination, as measured by the NCI Common Toxicity Criteria version 3.0 [ Time Frame: 12 months ]


    Original Secondary Outcome: Same as current

    Information By: Hoosier Cancer Research Network

    Dates:
    Date Received: February 18, 2010
    Date Started: June 2010
    Date Completion:
    Last Updated: August 17, 2015
    Last Verified: August 2015