Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004979
Status:
COMPLETED
Last Update Posted:
2014-01-06
First Post:
2000-03-07
Brief Title:
Topotecan and Paclitaxel in Treating Patients With Advanced Non-small Cell Lung Cancer or Other Advanced Solid Tumors
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Oral Topotecan and Intravenous Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer Phases I and II and Other Advanced Solid Tumors Phase I Only
Status:
COMPLETED
Status Verified Date:
2001-01
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 III trial to study the effectiveness of combining topotecan and paclitaxel in treating patients who have advanced non-small cell lung cancer or other advanced solid tumors
PURPOSE Phase III trial to study the effectiveness of combining topotecan and paclitaxel in treating patients who have advanced non-small cell lung cancer or other advanced solid tumors
Detailed Description:
OBJECTIVES Phase I I Determine the maximum tolerated dose MTD of oral topotecan combined with a fixed dose of paclitaxel in patients with advanced non-small lung cancer NSCLC and other advanced solid tumors II Determine the response rate of NSCLC patients treated at the MTD of oral topotecan combined with intravenous paclitaxel III Determine the dose limiting toxicities of this drug combination in this patient population Phase II IV Determine the toxicities of this regimen at its MTD in patients with NSCLC V Determine time to response response duration survival time to progression and rate of stable disease of patients with NSCLC treated with this regimen at the MTD VI Assess changes in well-being of patients with NSCLC treated with this regimen at the MTD
OUTLINE This is a dose escalation study of topotecan Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours on day 1 Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities Once the MTD is determined additional patients with non-small cell lung cancer are accrued to receive treatment with topotecan and paclitaxel at the recommended phase II dose Quality of life is assessed in the phase II portion of the study at baseline before each treatment course and at the end of the study Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for the phase I dose escalation portion of this study A total of 14-40 additional non-small cell lung cancer patients will be accrued to the phase II portion of this study
OUTLINE This is a dose escalation study of topotecan Patients receive oral topotecan on days 1-5 and paclitaxel IV over 3 hours on day 1 Treatment continues every 21 days in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose limiting toxicities Once the MTD is determined additional patients with non-small cell lung cancer are accrued to receive treatment with topotecan and paclitaxel at the recommended phase II dose Quality of life is assessed in the phase II portion of the study at baseline before each treatment course and at the end of the study Patients are followed at 3 weeks
PROJECTED ACCRUAL A total of 3-24 patients will be accrued for the phase I dose escalation portion of this study A total of 14-40 additional non-small cell lung cancer patients will be accrued to the phase II portion of this study
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-G00-1676 | None | None | None |
| UCLA-9904034 | None | None | None |
| SB-104864250 | None | None | None |