Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004160
Status:
COMPLETED
Last Update Posted:
2013-11-26
First Post:
1999-12-10
Brief Title:
Chemotherapy Plus Radiation Therapy in Treating Patients With Stage III Non-small Cell Lung Cancer That Cannot Be Surgically Removed
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Sequential and Concomitant Chemoradiotherapy With Gemcitabine-Based Chemotherapy for Inoperable Stage IIIa and IIIb Non-Small Cell Lung Cancer A Phase IIIa Study
Status:
COMPLETED
Status Verified Date:
2005-10
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 Radiation therapy uses high-energy x-rays to damage tumor cells Combining chemotherapy with radiation therapy may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be surgically removed
PURPOSE Phase III trial to study the effectiveness of chemotherapy plus radiation therapy in treating patients who have stage III non-small cell lung cancer that cannot be surgically removed
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicity of gemcitabine and paclitaxel in combination with radiotherapy in patients with locally advanced stage IIIA or IIIB non-small cell lung cancer II Assess response rate duration of response disease free survival and failure in this patient population on this regimen III Determine the pharmacokinetics of gemcitabine and paclitaxel during the chemoradiotherapy phase
OUTLINE This is a dose escalation study of gemcitabine Induction phase Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for 2 courses Chemoradiotherapy phase Patients receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into paclitaxel infusion on day 1 of weeks 6 9 and 12 Patients undergo conventional chest radiotherapy on Monday though Friday for weeks 6-11 Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 5 patients experience dose limiting toxicity
PROJECTED ACCRUAL A minimum of 17 patients will be accrued for this study
OUTLINE This is a dose escalation study of gemcitabine Induction phase Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1 Treatment repeats every 3 weeks for 2 courses Chemoradiotherapy phase Patients receive paclitaxel IV over 1 hour and gemcitabine IV over 30 minutes beginning 2 hours into paclitaxel infusion on day 1 of weeks 6 9 and 12 Patients undergo conventional chest radiotherapy on Monday though Friday for weeks 6-11 Cohorts of 3-5 patients receive escalating doses of gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose at which at least 2 of 5 patients experience dose limiting toxicity
PROJECTED ACCRUAL A minimum of 17 patients will be accrued for 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-G99-1625 | None | None | None |
| UAB-9718 | None | None | None |
| UAB-F97073005 | None | None | None |