Ignite Creation Date:
2024-05-05 @ 1:18 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002587
Status:
COMPLETED
Last Update Posted:
2013-06-03
First Post:
1999-11-01
Brief Title:
Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A PHASE I STUDY OF PROLONGED LOW-DOSE TOPOTECAN INFUSION COMBINED WITH PACLITAXEL TAXOL
Status:
COMPLETED
Status Verified Date:
2001-04
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:
Phase I trial to study the effectiveness of paclitaxel plus topotecan in treating patients who have solid tumors 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
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose and quantitative and qualitative toxic effects of topotecan and paclitaxel in patients with solid tumors
II Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation study of topotecan and paclitaxel
Patients receive paclitaxel IV over 3 hours on day 1 followed 2-6 hours later by topotecan IV continuously on days 1-14 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of topotecan and paclitaxel until the maximum tolerated dose MTD of each drug is determined The MTD is defined as the highest dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 10-20 patients will be accrued for this study within 8-12 months
I Determine the maximum tolerated dose and quantitative and qualitative toxic effects of topotecan and paclitaxel in patients with solid tumors
II Determine the antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation study of topotecan and paclitaxel
Patients receive paclitaxel IV over 3 hours on day 1 followed 2-6 hours later by topotecan IV continuously on days 1-14 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of topotecan and paclitaxel until the maximum tolerated dose MTD of each drug is determined The MTD is defined as the highest dose preceding that at which 2 of 6 patients experience dose-limiting toxicity
PROJECTED ACCRUAL Approximately 10-20 patients will be accrued for this study within 8-12 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 |
|---|---|---|---|
| CDR0000063738 | REGISTRY | PDQ Physician Data Query | None |
| NYU-9315 | None | None | None |
| NCI-T93-0115D | None | None | None |