Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-06-08 @ 3:46 PM
Study NCT ID:
NCT00098956
Status:
COMPLETED
Last Update Posted:
2018-07-23
First Post:
2004-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
7-hydroxystaurosporine and Topotecan Hydrochloride in Treating Patients With Relapsed or Progressed Small Cell Lung Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
A Phase II Study of UCN-01 in Combination With Topotecan in Patients With SCLC Who Relapsed or Progressed >= 3 Months After Completing First-Line Platinum-Based Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-07
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:
This phase II trial is studying how well giving UCN-01 together with topotecan works in treating patients with small cell lung cancer that relapsed or progressed after previous chemotherapy. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. UCN-01 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It may also increase the effectiveness of topotecan by making tumor cells more sensitive to the drug. Giving UCN-01 together with topotecan may kill more tumor cells.
Detailed Description:
PRIMARY OBJECTIVES:
I. To determine the anti tumour activity of UCN-01 in combination with topotecan in patients with SCLC who relapsed or progressed \>= 3 months after completing first-line platinum-based chemotherapy (patient with sensitive disease) using objective response rates (complete and partial).
SECONDARY OBJECTIVES:
I. To determine the anti tumour activity of UCN-01 in combination with topotecan with regards to stable disease rate, median and overall survival rates as well as to determine the safety and tolerability of this combination.
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR.
Patients are followed for survival.
I. To determine the anti tumour activity of UCN-01 in combination with topotecan in patients with SCLC who relapsed or progressed \>= 3 months after completing first-line platinum-based chemotherapy (patient with sensitive disease) using objective response rates (complete and partial).
SECONDARY OBJECTIVES:
I. To determine the anti tumour activity of UCN-01 in combination with topotecan with regards to stable disease rate, median and overall survival rates as well as to determine the safety and tolerability of this combination.
OUTLINE: This is a multicenter study.
Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR.
Patients are followed for survival.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: