Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004137
Status:
COMPLETED
Last Update Posted:
2013-02-15
First Post:
1999-12-10
Brief Title:
S9914 Combination Chemotherapy Plus Filgrastim in Untreated Extensive-Stage Small Cell Lung Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase II Trial of Paclitaxel Carboplatin and Topotecan With G-CSF in Untreated Patients With Extensive Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2013-02
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 Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a persons immune system recover from the side effects of chemotherapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus filgrastim in treating patients who have previously untreated extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES I Assess the survival and response rate of patients with previously untreated extensive stage small cell lung cancer treated with paclitaxel carboplatin topotecan and filgrastim G-CSF II Determine the side effects and toxicity of this regimen in these patients
OUTLINE Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4 Patients receive filgrastim G-CSF subcutaneously once daily beginning on day 5 and continuing until blood counts recover G-CSF must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study over 18 months
OUTLINE Patients receive topotecan IV over 30 minutes on days 1-4 and paclitaxel IV over 1 hour followed by carboplatin IV over 1 hour prior to topotecan on day 4 Patients receive filgrastim G-CSF subcutaneously once daily beginning on day 5 and continuing until blood counts recover G-CSF must be discontinued at least 24 hours prior to beginning each subsequent course of chemotherapy Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 6 months for 3 years
PROJECTED ACCRUAL A total of 75 patients will be accrued for this study over 18 months
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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S9914 | OTHER | None | None |