Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002519
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
1999-11-01
Brief Title:
Paclitaxel Plus Radiation Therapy in Treating Patients With Untreated Stage III Non-small Cell Lung Cancer
Sponsor:
Vanderbilt-Ingram Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PH I Continuous Infusion Taxol in Combination With Thoracic Radiation Therapy in Untreated Locally Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2011-04
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:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining radiation therapy with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of chemotherapy with paclitaxel in combination with radiation therapy to the chest in patients with previously untreated stage III non-small cell lung cancer that cannot be surgically removed
PURPOSE Phase I trial to study the effectiveness of chemotherapy with paclitaxel in combination with radiation therapy to the chest in patients with previously untreated stage III non-small cell lung cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine the toxicity and maximum tolerated dose of paclitaxel when combined with standard thoracic radiotherapy in patients with locally advanced non-small cell lung cancer II Determine the plasma levels of paclitaxel in these patients III Determine the effect of this regimen on the tumor cell cycle distribution in these patients
OUTLINE This is a dose-escalation study of paclitaxel Patients undergo standard thoracic radiotherapy 5 days a week for 7 weeks Patients receive paclitaxel IV continuously beginning 48 hours before initiating radiotherapy and continuing until the last day of radiotherapy Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-5 patients receive escalating doses of paclitaxel 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 5 patients experience dose-limiting toxicity Patients are followed monthly for 2 years
PROJECTED ACCRUAL A total of 3-5 patients per dose level will be accrued for this study within 2 years
OUTLINE This is a dose-escalation study of paclitaxel Patients undergo standard thoracic radiotherapy 5 days a week for 7 weeks Patients receive paclitaxel IV continuously beginning 48 hours before initiating radiotherapy and continuing until the last day of radiotherapy Treatment continues in the absence of disease progression or unacceptable toxicity Cohorts of 3-5 patients receive escalating doses of paclitaxel 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 5 patients experience dose-limiting toxicity Patients are followed monthly for 2 years
PROJECTED ACCRUAL A total of 3-5 patients per dose level will be accrued for this study within 2 years
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-T92-0246D | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA068485 |
| P30CA068485 | NIH | None | None |
| VU-VCC-LUN-65 | None | None | None |
| UPCC-3597 | None | None | None |