Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004159
Status:
TERMINATED
Last Update Posted:
2013-11-20
First Post:
1999-12-10
Brief Title:
Gemcitabine Plus Paclitaxel in Treating Patients With Advanced Non-small Cell Lung Cancer or Other Solid Tumor
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Biweekly Gemcitabine and Paclitaxel in Patients With Advanced Non-Small Cell Lung Cancer and Solid Tumors A Phase IIIa Study
Status:
TERMINATED
Status Verified Date:
2013-03
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 gemcitabine plus paclitaxel in treating patients who have advanced non-small cell lung cancer or other solid tumor
PURPOSE Phase III trial to study the effectiveness of gemcitabine plus paclitaxel in treating patients who have advanced non-small cell lung cancer or other solid tumor
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose and dose limiting toxicities of biweekly administration of gemcitabine and paclitaxel in patients with advanced non-small cell lung cancer NSCLC or other solid tumor II Determine the response rate duration of response and disease free interval for this patient population after this therapy
OUTLINE This is a dose escalation study Patients receive paclitaxel IV over 1 hour followed 2 hours later by gemcitabine IV over 30 minutes on days 1 15 and 29 Treatment repeats every 6 weeks for a maximum of 8 courses Cohorts of 3-5 patients receive escalating doses of paclitaxel and gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicity Once the MTD is reached an additional 14 patients chemotherapy naive with advanced NSCLC are treated at the recommended phase II dose Patients are followed every 8 weeks for 6 months
PROJECTED ACCRUAL A minimum of 3 patients will be accrued for the phase I portion and a total of 14 patients will be accrued for the phase II portion of this study
OUTLINE This is a dose escalation study Patients receive paclitaxel IV over 1 hour followed 2 hours later by gemcitabine IV over 30 minutes on days 1 15 and 29 Treatment repeats every 6 weeks for a maximum of 8 courses Cohorts of 3-5 patients receive escalating doses of paclitaxel and gemcitabine until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 5 patients experience dose limiting toxicity Once the MTD is reached an additional 14 patients chemotherapy naive with advanced NSCLC are treated at the recommended phase II dose Patients are followed every 8 weeks for 6 months
PROJECTED ACCRUAL A minimum of 3 patients will be accrued for the phase I portion and a total of 14 patients will be accrued for 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-G99-1624 | None | None | None |
| UAB-9720 | None | None | None |
| UAB-F970730006 | None | None | None |