Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281970
Status:
COMPLETED
Last Update Posted:
2019-01-17
First Post:
2006-01-24
Brief Title:
Docetaxel and Cisplatin in Treating Patients With Stage I Stage II or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
Phase II Trial of Weekly Docetaxel Taxotere and Monthly Cisplatin Chemotherapy as Adjuvant Treatment for Patients With Completely Resected Non-small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-10
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 such as docetaxel and cisplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage I stage II or stage III non-small cell lung cancer that has been completely removed by surgery
PURPOSE This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage I stage II or stage III non-small cell lung cancer that has been completely removed by surgery
Detailed Description:
OBJECTIVES
Primary
Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung Cancer Trial IALT in patients with completely resected stage IA-IIIB non-small cell lung cancer
Secondary
Explore the relationship of time to recurrence disease-free survival and overall survival of these patients with levels of circulating DNA and proteomic analysis of serum
OUTLINE This is an open-label study
Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 and cisplatin IV over 8 hours on day 15 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung Cancer Trial IALT in patients with completely resected stage IA-IIIB non-small cell lung cancer
Secondary
Explore the relationship of time to recurrence disease-free survival and overall survival of these patients with levels of circulating DNA and proteomic analysis of serum
OUTLINE This is an open-label study
Patients receive docetaxel IV over 30 minutes on days 1 8 and 15 and cisplatin IV over 8 hours on day 15 Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000455112 | OTHER | other | httpsreporternihgovquickSearchP30CA006973 |
| P30CA006973 | NIH | None | None |
| JHOC-J0435 | None | None | None |
| 20040761 | OTHER | None | None |
| MSKCC-04039 | None | None | None |