Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002972
Status:
COMPLETED
Last Update Posted:
2012-07-02
First Post:
1999-11-01
Brief Title:
Paclitaxel in Treating Patients With Lung Cancer
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Study on TAXOL in Bronchioalveolar Carcinoma
Status:
COMPLETED
Status Verified Date:
2012-06
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
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB stage IV or recurrent lung cancer
PURPOSE Phase II trial to study the effectiveness of paclitaxel in treating patients who have unresectable stage IIIB stage IV or recurrent lung cancer
Detailed Description:
OBJECTIVES
Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma BAC
Assess the duration of response in patients presenting with an objective response
Characterize the acute side effects of paclitaxel in patients with BAC
Assess the role of some biological parameters in the natural history and the response to therapy of BAC evaluate the expression of Ki67 p53 and K-ras mutation
OUTLINE This is an open label nonrandomized multicenter study
Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur
Disease is assessed every 6 weeks until documented progression treatment side effects are assessed separately for each cycle of therapy Treatment is given up to a maximum of 6 cycles of therapy or until disease progression unacceptable toxicity or patient refusal occurs
PROJECTED ACCRUAL 16 or 25 patients will be accrued
Assess the therapeutic activity of paclitaxel in patients with bronchoalveolar carcinoma BAC
Assess the duration of response in patients presenting with an objective response
Characterize the acute side effects of paclitaxel in patients with BAC
Assess the role of some biological parameters in the natural history and the response to therapy of BAC evaluate the expression of Ki67 p53 and K-ras mutation
OUTLINE This is an open label nonrandomized multicenter study
Paclitaxel is administered every 3 weeks as a 3 hour continuous infusion in dextrose or normal saline Patients are treated for a minimum of 2 cycles unless serious toxicity or complication occur
Disease is assessed every 6 weeks until documented progression treatment side effects are assessed separately for each cycle of therapy Treatment is given up to a maximum of 6 cycles of therapy or until disease progression unacceptable toxicity or patient refusal occurs
PROJECTED ACCRUAL 16 or 25 patients will be accrued
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 |
|---|---|---|---|
| EORTC-08956 | None | None | None |