Study Evaluating the Safety and Tolerability of L-377202
The primary purpose of this study is to (1) determine the maximally tolerated dose (MTD) of L-377202 administered once every 3 weeks, (2) evaluate the safety and tolerability of L-377202 including the dose-limiting adverse effects of treatment with L-377202, and (3) assess the pharmacokinetics of various doses of L-377202 and the plasma profile of liberated doxorubicin and leu-doxorubicin.
Hormone Refractory Prostate Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PhaseI/II Study Evaluating the Safety, Tolerability, and Maximally Tolerated Dose of L-377202 Administered Once Every 3 Weeks|
- Evaluation of the administration of L-377202 every three weeks in patients with hormone refractory prostate cancer [ Time Frame: Every 3 weeks until disease progression or unacceptable toxicity ] [ Designated as safety issue: Yes ]
- Evaluation of the radiologic and/or PSA responses to L-377202 treatment [ Time Frame: Every 3 weeks until disease progression or unacceptable toxicity ] [ Designated as safety issue: No ]
|Study Start Date:||March 1999|
|Study Completion Date:||November 2001|
|Primary Completion Date:||September 2000 (Final data collection date for primary outcome measure)|
|Experimental: infusion of L-377202||
For each cycle, L-377202 will be administered as a 30-minute infusion every 3 weeks. The starting dose will be 20 mg/m2/week. Doses will be doubled until a patient experiences a greater than or equal to Grade 2 toxicity.
This is an open, nonrandomized, rising-dose study in patients with hormone refractory prostate cancer. Patients will be treated with L-377202 once every three weeks. Plasma concentrations of L-377202, liberated doxorubicin, and leu-doxorubicin will be obtained at defined time intervals throughout the study. At least 1 patient will be treated at each dose level until there is evidence of greater than or equal to Grade 2 drug-related toxicity. Each patient will be treated at only 1 dose level, although multiple cycles may be administered until signs of disease progression or unacceptable toxicity are evident. Doses will be doubled for each subsequent cohort of patients until evidence of greater than or equal to Grade 2 drug-related toxicity. Upon documentation of greater than or equal to Grade 2 drug-related toxicity, subsequent dose escalations will proceed along the modified Fibonacci scale and enroll at least 3 patients per dose level until 1 patient experiences dose-limiting toxicity (DLT).
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||John Rinehart, M.D.||University of Alabama at Birmingham (no longer employee)|
|Principal Investigator:||Scot Ebbinghaus, M.D.||University of Alabama at Birmingham (no longer employee)|