Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of liposomal lurtotecan plus cisplatin in treating patients who have advanced or metastatic solid tumors.
Head and Neck Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Drug: lurtotecan liposome
|Study Design:||Primary Purpose: Treatment|
|Official Title:||A Phase I Study of NX 211 in Combination With Cisplatin Given as an IV Infusion Days 1, 2, and 3 Every 3 Weeks in Patients With Solid Tumors|
|Study Start Date:||April 2000|
|Estimated Study Completion Date:||December 2009|
OBJECTIVES: I. Determine the maximum tolerated dose and recommended phase II dose of lurtotecan liposome and cisplatin in patients with advanced solid tumors. II. Determine the toxicity profile, dose-limiting toxic effects, and the pharmacokinetics of this treatment regimen in this patient population. III. Determine any correlation between toxicity profile and pharmacokinetics of this treatment regimen in these patients. IV. Determine the objective tumor response to this treatment regimen in patients with measurable disease (previously untreated solid tumors) entered at the recommended phase II dose.
OUTLINE: This is an open-label, multicenter, dose-escalation study of lurtotecan liposome. Patients receive cisplatin IV over 1 hour followed by lurtotecan liposome IV over 30 minutes on days 1-3. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity. Once the total dose of cisplatin is reached, patients receive lurtotecan liposome alone. Patients achieving complete response (CR) continue therapy for 2 courses after documentation of confirmed CR. Patients achieving partial response (PR) continue therapy until progression or for 2 courses after documentation of stable PR. Patients with stable disease continue therapy for a maximum of 6 courses. Cohorts of 3-6 patients receive escalating doses of lurtotecan liposome until the maximum tolerated dose (MTD) is reached. The MTD is defined as the dose at which at least 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, up to 10 patients with previously untreated solid tumors are treated at the recommended phase II dose (1 dose below the MTD). Patients are followed at 4 weeks and then every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006036
|Canada, British Columbia|
|British Columbia Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Cancer Care Ontario-Hamilton Regional Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Toronto General Hospital|
|Toronto, Ontario, Canada, M5G 2C4|
|Study Chair:||Hal W. Hirte, MD, FRCP(C)||Margaret and Charles Juravinski Cancer Centre|