Clinical Trial: Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Phase I Dose Escalation and Landmark Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma (UTUC) Following Endoscopic Resection

Brief Summary: The purpose of this study is to learn more about how well the drug valrubicin (VALSTAR®) works to help treat the patient's cancer when administered through a nephrostomy tube inserted through their back into their kidney. The study is also being done to determine how safe and easy it is to tolerate valrubicin at specific dose levels, as well as the way in which the drug is eliminated from the human body (Pharmacokinetics or PK).

Detailed Summary: Eligible patients will receive percutaneous valrubicin beginning no sooner than 10 days following nephrostomy placement and within 6 weeks of tumor treatment/resection. Therapy will be administered at one of three dose levels in a 3 + 3 design (200 mg/75 ml diluent, 400 mg/75 ml diluent or 800 mg/75 ml diluent). It is anticipated that at least 3 patients will be accrued at both of the 200 and 400 mg dose levels. Assuming acceptable toxicity, the accrual target for the 800 mg dose level will be 9 patients. If the maximum tolerated dose is determined to be 200 mg or 400 mg, expansion to 9 patients will occur at the maximum tolerated dose (MTD) dose level. Drug will be administered on a weekly basis for 8 total treatments.
Sponsor: H. Lee Moffitt Cancer Center and Research Institute

Current Primary Outcome: Maximum Tolerated Dose (MTD) [ Time Frame: 12 months ]

To define the maximum-tolerated dose (MTD) in a multiple dose regimen of valrubicin administered through a percutaneous nephrostomy tube placed following endoscopic resection (percutaneous or ureteroscopic) of UTUC


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Participants with Recurrence Free Survival (RFS) [ Time Frame: 12 months ]
    To evaluate the landmark (1 year) recurrence free survival (RFS). Recurrence is defined as any tumor recurrence in the upper tract following initiation of percutaneous valrubicin.
  • Number of Participants with Progression Free Survival (PFS) [ Time Frame: 12 months ]
    To evaluate the landmark (1 year) progression free survival (PFS) post valrubicin treatment. Progression is defined as a tumor recurrence in the upper tract of higher clinical stage and/or higher tumor grade following initiation of percutaneous valrubicin.


Original Secondary Outcome: Same as current

Information By: H. Lee Moffitt Cancer Center and Research Institute

Dates:
Date Received: May 23, 2012
Date Started: July 2012
Date Completion:
Last Updated: April 21, 2016
Last Verified: April 2016