Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003860
Status:
COMPLETED
Last Update Posted:
2021-02-21
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Patients With Small Cell Lung Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Intensive Chemotherapy With Peripheral Blood Stem Cell Support for Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2021-02
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 chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating patients who have small cell lung cancer
Detailed Description:
OBJECTIVES I Determine the feasibility of the administration of intensive chemotherapy with ifosfamide carboplatin and etoposide followed by peripheral blood stem cell support in patients with small cell lung cancer II Determine the rate and duration of response in these patients after this treatment III Determine the progression free and overall survival of these patients
OUTLINE This is an open label multicenter study Patients receive 4 courses of intensive chemotherapy consisting of ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2 Filgrastim G-CSF is administered subcutaneously beginning on day 2 and continuing until blood cell counts recover Courses repeat every 14 days Peripheral blood stem cells PBSC are collected after course 1 PBSC are reinfused on day 3 of courses 2 and 3 Patients who experience a complete response receive prophylactic cerebral irradiation on day 71 Patients are followed every 2 months for 5 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 18 months
OUTLINE This is an open label multicenter study Patients receive 4 courses of intensive chemotherapy consisting of ifosfamide IV over 24 hours and carboplatin IV over 1 hour on day 1 and etoposide IV over 1 hour on days 1 and 2 Filgrastim G-CSF is administered subcutaneously beginning on day 2 and continuing until blood cell counts recover Courses repeat every 14 days Peripheral blood stem cells PBSC are collected after course 1 PBSC are reinfused on day 3 of courses 2 and 3 Patients who experience a complete response receive prophylactic cerebral irradiation on day 71 Patients are followed every 2 months for 5 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study within 18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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 |
|---|---|---|---|
| FRE-FNCLCC-CLEOPATRE03 | None | None | None |
| FRE-FNCLCC-98003-CLEO | None | None | None |
| EU-98072 | None | None | None |