Lurtotecan Liposome in Treating Patients With Advanced Solid Tumors
|ClinicalTrials.gov Identifier: NCT00003891|
Recruitment Status : Completed
First Posted : June 17, 2004
Last Update Posted : November 9, 2010
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 lurtotecan liposome in treating patients who have advanced solid tumors.
|Condition or disease||Intervention/treatment||Phase|
|Unspecified Adult Solid Tumor, Protocol Specific||Drug: lurtotecan liposome||Phase 1|
OBJECTIVES: I. Determine the maximum tolerated dose (MTD) and the future dose of lurtotecan liposome in patients with advanced solid tumors. II. Assess the toxicity and pharmacokinetics of this treatment regimen in this patient population. III. Assess the response to this regimen by patients with measurable disease.
OUTLINE: This is a dose escalation, multicenter study. Patients receive lurtotecan liposome (NX211) IV over 30 minutes on days 1, 2, and 3. Courses are repeated every 3 weeks. Treatment continues for up to 6 courses in the absence of unacceptable toxicity or disease progression. The dose of NX211 is escalated in cohorts of 3-6 patients until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity. Patients are followed at 4 weeks and every 3 months for 1 year.
PROJECTED ACCRUAL: A total of 20-25 patients will be accrued for this study within 12-15 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Official Title:||A Phase I Study of NX211 Given as an IV Infusion Days 1, 2 and 3 Every 3 Weeks in Patients With Solid Tumors|
|Study Start Date :||February 1999|
|Actual Study Completion Date :||September 2009|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003891
|Canada, British Columbia|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Cancer Care Ontario-Hamilton Regional Cancer Centre|
|Hamilton, Ontario, Canada, L8V 5C2|
|Study Chair:||Karen A. Gelmon, MD||British Columbia Cancer Agency|