Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006047
Status:
COMPLETED
Last Update Posted:
2012-09-26
First Post:
2000-07-05
Brief Title:
Combination Therapy With Oral 9-Nitrocamptothecin Oral Etoposide
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
Phase I Study of Combination Therapy With Oral 9-Nitrocamptothecin and Oral Etoposide
Status:
COMPLETED
Status Verified Date:
2012-09
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 drug may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of nitrocamptothecin plus etoposide in treating patients who have advanced solid tumors
PURPOSE Phase I trial to study the effectiveness of nitrocamptothecin plus etoposide in treating patients who have advanced solid tumors
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose dose limiting toxicity and safety of nitrocamptothecin when administered with etoposide in patients with advanced solid tumors II Determine the changes in expression and activity of topoisomerase I and II which occur during administration of this treatment regimen in these patients III Determine the plasma pharmacokinetics of this treatment regimen in these patients IV Compare the hematologic and nonhematologic toxicities with this treatment regimen in patients 70 years of age and older versus patients younger than 70 years of age
OUTLINE This is a dose escalation study of nitrocamptothecin Patients receive oral nitrocamptothecin on days 1-3 and oral etoposide on days 4-5 each week Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of nitrocamptothecin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Patients are followed every 4 weeks until toxicities resolve
PROJECTED ACCRUAL Approximately 40-60 patients will be accrued for this study over 18 to 24 months
OUTLINE This is a dose escalation study of nitrocamptothecin Patients receive oral nitrocamptothecin on days 1-3 and oral etoposide on days 4-5 each week Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-6 patients receive escalating doses of nitrocamptothecin until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities Patients are followed every 4 weeks until toxicities resolve
PROJECTED ACCRUAL Approximately 40-60 patients will be accrued for this study over 18 to 24 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-G00-1821 | OTHER | NCI | None |