Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006036
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2000-07-05
Brief Title:
Liposomal Lurtotecan Plus Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Sponsor:
NCIC Clinical Trials Group
Organization:
Canadian Cancer Trials Group
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2020-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000068051 | OTHER | PDQ | None |
| CAN-NCIC-IND133 | OTHER | None | None |
| NEXSTAR-110-05 | OTHER | None | None |