Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003719
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Evaluation of Irinotecan CPT-11 in Previously Treated Advanced Sarcomas
Status:
UNKNOWN
Status Verified Date:
2001-08
Last Known Status:
ACTIVE_NOT_RECRUITING
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
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have stage IV or recurrent soft tissue sarcoma that has been previously treated with chemotherapy
PURPOSE Phase II trial to study the effectiveness of irinotecan in treating patients who have stage IV or recurrent soft tissue sarcoma that has been previously treated with chemotherapy
Detailed Description:
OBJECTIVES I Evaluate the efficacy of irinotecan in patients with metastatic recurrent or unresectable locally advanced previously treated soft tissue sarcoma II Assess the clinical and laboratory toxic effects and patient tolerance of this regimen in these patients
OUTLINE Patients receive irinotecan IV over 90 minutes weekly for 4 weeks followed by 2 weeks of rest Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for the first two years then every 6 months for the next two years and every 12 months thereafter until death
PROJECTED ACCRUAL A total of 14-27 patients will be accrued for this study in 18-36 months
OUTLINE Patients receive irinotecan IV over 90 minutes weekly for 4 weeks followed by 2 weeks of rest Treatment continues every 6 weeks in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months for the first two years then every 6 months for the next two years and every 12 months thereafter until death
PROJECTED ACCRUAL A total of 14-27 patients will be accrued for this study in 18-36 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| NCI-V98-1511 | None | None | None |
| CPMC-IRB-8100 | None | None | None |