LY231514 in Treating Patients With Locally Advanced or Metastatic Solid Tumors and Varying Degrees of Kidney Function
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Chemotherapy drugs may have different effects in patients with different degrees of kidney function.
PURPOSE: Phase I trial to study the effectiveness of LY231514 in treating patients who have locally advanced or metastatic solid tumors and varying degrees of kidney function.
Unspecified Adult Solid Tumor, Protocol Specific
Drug: pemetrexed disodium
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Pharmacokinetic Trial of LY231514 Administered Intravenously Every 3 Weeks in Advanced Cancer Patients With Varying Degrees of Renal Function|
|Study Start Date:||April 1998|
|Study Completion Date:||June 2002|
|Primary Completion Date:||June 2002 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the toxic effects and maximum tolerated dose (MTD) of LY231514 in patients with metastatic or locally advanced solid tumors and varying degrees of renal function. II. Determine the recommended dose for LY231514 in this patient population. III. Examine the effects of renal dysfunction on the pharmacokinetics of LY231514 in this patient population. IV. Examine the relationship between impaired renal function, drug exposure, and drug effects in these patients. V. Gather data for development of a LY231514 dosing nomogram based on renal function. VI. Collect preliminary data regarding antitumor effects of LY231514 in this patient population.
OUTLINE: This is an open label, dose escalation study. Patients are stratified according to renal function. Group 1 consists of patients with normal renal function, and groups 2, 3, and 4 consist of patients with mild, moderate, and severe renal impairment. All patients receive LY231514 IV over 10 minutes every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients are treated with escalating doses of LY231514 within each treatment group. If dose limiting toxicity (DLT) is observed in 1 of 3 patients at a given dose level, then 3 additional patients are studied. The maximum tolerated dose is defined as the dose level at which less than 2 of 6 patients experience DLT. Patients are followed until death.
PROJECTED ACCRUAL: Up to 50 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003706
|United States, Texas|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States, 78229-3264|
|Study Chair:||Eric K. Rowinsky, MD||San Antonio Cancer Institute|