NCT00006036

Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Head and Neck Cancer
• Lung Cancer
• Ovarian Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
DRUG	cisplatin
DRUG	lurtotecan liposome

Timeline

• Start date: 2000-03-22
• Primary completion: 2002-09-26
• Completion: 2009-12-21
• First posted: 2004-03-25
• Last updated: 2020-04-06

Locations

3 sites across 1 country: Canada