Irinotecan in Treating Patients With Stage IV or Recurrent Soft Tissue Sarcoma
Phase II Evaluation of Irinotecan (CPT-11) in Previously Treated Advanced Sarcomas
Sponsor: Herbert Irving Comprehensive Cancer Center
Listed as NCT00003719, this PHASE2 trial focuses on Sarcoma and remains ongoing. Sponsored by Herbert Irving Comprehensive Cancer Center, it has been updated 5 times since 1997, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
5 versions recorded-
Sep 2024 — Present [monthly]
Unknown PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE2
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE2
-
Jan 2017 — Jun 2018 [monthly]
Unknown Status PHASE2
First recorded
Jul 1997
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Herbert Irving Comprehensive Cancer Center
For direct contact, visit the study record on ClinicalTrials.gov .