Clinical Trial: 506U78 in Treating Patients With Hematologic Cancer and Kidney or Liver Impairment

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase I Study of Compound 506U78 (NSC #686673) in Patients With Hematologic Malignancies and Renal or Hepatic Impairment

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of 506U78 in treating patients who have hematologic cancer and kidney or liver impairment.

Detailed Summary:

OBJECTIVES: I. Determine the maximum tolerated dose of 506U78 in patients with hematologic malignancies and renal or hepatic impairment. II. Establish dosing guidelines for this drug in this patient population. III. Determine the toxicities and pharmacokinetics of this drug in these patients.

OUTLINE: Patients are stratified into 5 groups according to renal and hepatic function: Group 1: Normal renal function and normal hepatic function Group 2: Moderate renal impairment and normal hepatic function Group 3: Severe renal impairment and normal hepatic function Group 4: End stage renal impairment and normal hepatic function Group 5: Normal renal function and moderate hepatic impairment Group 1: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Groups 2-5: Patients receive 506U78 IV over 2 hours on days 1, 3, and 5. Dose escalation occurs independently in each of the treatment groups. Cohorts of 3-6 patients receive escalating doses of 506U78 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities. Treatment repeats every 4 weeks for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.

Sponsor: Alliance for Clinical Trials in Oncology

Current Primary Outcome: Maximum tolerated dose [ Time Frame: Up to 6 months ]

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Alliance for Clinical Trials in Oncology

Dates:
Date Received: January 28, 2000
Date Started: December 1999
Date Completion:
Last Updated: July 1, 2016
Last Verified: July 2016