Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00077311
Status:
COMPLETED
Last Update Posted:
2016-06-30
First Post:
2004-02-10
Brief Title:
Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-06
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 such as docetaxel and cisplatin work in different ways to stop tumor cells from dividing so they stop growing or die Chemoprotective drugs such as dimesna may help prevent or decrease the side effects such as nerve kidney and inner ear damage caused by chemotherapy
PURPOSE This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer
PURPOSE This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without dimesna
Compare the feasibility of these regimens in terms of febrile neutropenia and treatment delays in these patients
Compare the objective response rate in patients treated with these regimens
Secondary
Compare the survival and failure-free survival of patients treated with these regimens
Compare the toxicity profile of these regimens in these patients
Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and pegfilgrastim subcutaneously SC on day 2
Arm II Patients receive docetaxel cisplatin and pegfilgrastim as in arm I and dimesna IV over 30 minutes on day 1
NOTE In both arms darbepoetin alfa is administered SC on day 1 of each course for hemoglobin 11 gdL
In both arms treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 2 years
Primary
Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without dimesna
Compare the feasibility of these regimens in terms of febrile neutropenia and treatment delays in these patients
Compare the objective response rate in patients treated with these regimens
Secondary
Compare the survival and failure-free survival of patients treated with these regimens
Compare the toxicity profile of these regimens in these patients
Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and pegfilgrastim subcutaneously SC on day 2
Arm II Patients receive docetaxel cisplatin and pegfilgrastim as in arm I and dimesna IV over 30 minutes on day 1
NOTE In both arms darbepoetin alfa is administered SC on day 1 of each course for hemoglobin 11 gdL
In both arms treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 1 year and then every 6 months for 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 |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-30303 | None | None | None |
| CDR0000350089 | REGISTRY | NCI Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |