Chemotherapy in Treating Patients With Advanced or Metastatic Solid Tumors
Recruitment status was: Active, not recruiting
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 intoplicine in treating patients who have advanced or metastatic solid tumors.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I, Pharmacokinetic, and Treatment Duration and Escalation Study of Intravenous Intoplicine Administered as a 5 to 21-Day Continuous Infusion Every 4 Weeks|
|Study Start Date:||August 1997|
OBJECTIVES: I. Determine the intolerable dose level of intoplicine in patients with locally advanced or metastatic cancer. II. Determine recommended phase II dose of intoplicine in these patients. III. Determine the principal and dose limiting toxicities of intoplicine in these patients, and determine the duration and reversibility of the toxicities. IV. Determine the magnitude of plasma concentrations that are achieved and maintained on this regimen and relate this parameter to toxicity outcome and antitumor activity. V. Determine preliminary evidence of antitumor activity of intoplicine in these patients.
OUTLINE: This is a dose escalation study. The first 3 patients receive intoplicine IV by continuous infusion for 5 days. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity. Subsequent cohorts of 3-6 patients receive escalating doses of intoplicine, first by increasing the number of days that the drug is infused to 10, 15, and 21, then by increasing the dosage and keeping the infusion time constant at 21 days. The intolerable dose level is defined as the lowest dose at which at least 2 of 3 or 6 patients experience dose limiting toxicity during course 1 or 2.
PROJECTED ACCRUAL: A total of 20-35 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00003713
|United States, Texas|
|Brooke Army Medical Center|
|Fort Sam Houston, Texas, United States, 78234|
|San Antonio Cancer Institute|
|San Antonio, Texas, United States, 78229|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Study Chair:||Gayle Cook, RN||Genzyme, a Sanofi Company|