Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002537
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Brief Title:
Radiation Therapy Plus Topotecan in Treating Patients With Non-small Cell Lung Cancer
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 CHEST IRRADIATION
Status:
COMPLETED
Status Verified Date:
2006-05
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 radiation therapy plus topotecan in treating patients who have non-small cell lung cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining chemotherapy and radiation therapy may kill more tumor cells
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of topotecan and chest irradiation in patients with non-small cell lung cancer
II Determine the qualitative and quantitative toxic effects of this regimen in these patients
III Determine the degree of antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation study of topotecan and thoracic radiotherapy
Beginning on day 1 patients receive topotecan IV continuously for 3-6 weeks and thoracic radiotherapy 5 days a week for 2 3 or 6 weeks Cohorts of 4-6 patients receive escalating doses of topotecan and thoracic radiotherapy until the maximum tolerated dose MTD of each therapy is determined The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity Six additional patients are treated at the MTD Patients who fail to achieve complete remission CR and continue to have measurable disease at 4-6 weeks after completion of radiotherapy receive topotecan IV continuously on days 1-21 at 1 dose level preceding the MTD as determined by the ongoing Protocol NYU-9123 Treatment continues every 4 weeks in the absence of unacceptable toxicity
I Determine the maximum tolerated dose of topotecan and chest irradiation in patients with non-small cell lung cancer
II Determine the qualitative and quantitative toxic effects of this regimen in these patients
III Determine the degree of antitumor activity of this regimen in these patients
OUTLINE This is a dose escalation study of topotecan and thoracic radiotherapy
Beginning on day 1 patients receive topotecan IV continuously for 3-6 weeks and thoracic radiotherapy 5 days a week for 2 3 or 6 weeks Cohorts of 4-6 patients receive escalating doses of topotecan and thoracic radiotherapy until the maximum tolerated dose MTD of each therapy is determined The MTD is defined as the dose preceding that at which 2 of 4 or 6 patients experience dose-limiting toxicity Six additional patients are treated at the MTD Patients who fail to achieve complete remission CR and continue to have measurable disease at 4-6 weeks after completion of radiotherapy receive topotecan IV continuously on days 1-21 at 1 dose level preceding the MTD as determined by the ongoing Protocol NYU-9123 Treatment continues every 4 weeks in the absence of unacceptable toxicity
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 |
|---|---|---|---|
| CDR0000078480 | REGISTRY | PDQ Physician Data Query | None |
| NYU-9301 | None | None | None |
| NCI-T93-0015D | None | None | None |