L-778,123 in Treating Patients With Recurrent or Refractory Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase I trial to study the effectiveness of L-778,123 in treating patients with recurrent or refractory solid tumors.
|Head and Neck Cancer Unspecified Adult Solid Tumor, Protocol Specific||Drug: L-778,123||Phase 1|
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Pharmacokinetic Study Evaluating the Safety, Tolerability and Maximally Tolerated Dose of 7-Day Continuous Infusions of L-778,123 in Patients With Recurrent of Refractory Solid Malignancies|
|Study Start Date:||April 1998|
|Study Completion Date:||April 2000|
|Primary Completion Date:||April 2000 (Final data collection date for primary outcome measure)|
OBJECTIVES: I. Determine the maximum tolerated dose of L-778,123 in patients with recurrent or refractory solid tumors. II. Evaluate the safety and tolerability of L-778,123 including qualitative, quantitative, and dose limiting toxicity in these patients. III. Assess the pharmacokinetic profile of this regimen in these patients. IV. Evaluate the radiologic or tumor marker responses to treatment in these patients. V. Evaluate the relationship between ras mutations and response to treatment in these patients. VI. Determine the relationship between plasma drug levels and farnesylation assay results.
OUTLINE: This is a dose escalation study. Patients receive continuous infusions of L-778,123 over 7 days every 3 weeks. Treatment continues in the absence of disease progression or unacceptable toxic effects. All patients are observed for at least 1 week after the 7 day infusion of L-778,123 prior to subsequent dose escalation. Cohorts of 3-6 patients receive escalating doses of L-778,123 until the maximum tolerated dose (MTD) is reached. MTD is defined as the dose at which no more than 2 of 6 patients experiences dose limiting toxicities. Patients are followed until death.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003430
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|Study Chair:||David R. Spriggs, MD||Memorial Sloan Kettering Cancer Center|