Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00028925
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2002-01-04
Brief Title:
Combination Chemotherapy With or Without Filgrastim in Treating Patients With Previously Untreated Extensive-Stage Small Cell Lung Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Trial of Oral Topotecan and Intravenous Carboplatin With G-CSF Filgrastim Support in Previously Untreated Patients With Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 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 compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated
PURPOSE Phase II trial to compare the effectiveness of combination chemotherapy with or without filgrastim in treating patients who have extensive-stage small cell lung cancer that has not been previously treated
Detailed Description:
OBJECTIVES
Determine the tolerability of topotecan and carboplatin with or without filgrastim G-CSF in patients with extensive stage small cell lung cancer
Determine response and survival rates in patients treated with these regimens
OUTLINE This is a multicenter study The first 12 patients are assigned to 1 of 2 treatment regimens 6 per regimen The next 33 patients receive treatment based on the toxicity experienced by the first 12
Regimen A
Patients receive oral topotecan once daily on days 1-5 carboplatin IV over 30 minutes on day 5 and filgrastim G-CSF subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover
Patients are evaluated after the first 3-week course of chemotherapy If no patient experiences unacceptable toxicity or febrile neutropenia or no more than 1 patient experiences an absolute neutrophil count of less than 500mm3 for more than 5 days the next 6 patients begin treatment on regimen B Otherwise all patients receive treatment as in regimen A
Regimen B
Patients receive topotecan and carboplatin as in regimen A
Patients are evaluated after the first 3-week course of chemotherapy If no patient experiences unacceptable toxicity or febrile neutropenia the next 33 patients receive treatment as in regimen B otherwise patients receive treatment as in regimen A
Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy WBRT Once WBRT is complete chemotherapy resumes
Quality of life is assessed at baseline and at the beginning of each course of chemotherapy
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 49 patients will be accrued for this study within 135 months
Determine the tolerability of topotecan and carboplatin with or without filgrastim G-CSF in patients with extensive stage small cell lung cancer
Determine response and survival rates in patients treated with these regimens
OUTLINE This is a multicenter study The first 12 patients are assigned to 1 of 2 treatment regimens 6 per regimen The next 33 patients receive treatment based on the toxicity experienced by the first 12
Regimen A
Patients receive oral topotecan once daily on days 1-5 carboplatin IV over 30 minutes on day 5 and filgrastim G-CSF subcutaneously once daily beginning on day 6 or 7 and continuing for up to 10 days or until blood counts recover
Patients are evaluated after the first 3-week course of chemotherapy If no patient experiences unacceptable toxicity or febrile neutropenia or no more than 1 patient experiences an absolute neutrophil count of less than 500mm3 for more than 5 days the next 6 patients begin treatment on regimen B Otherwise all patients receive treatment as in regimen A
Regimen B
Patients receive topotecan and carboplatin as in regimen A
Patients are evaluated after the first 3-week course of chemotherapy If no patient experiences unacceptable toxicity or febrile neutropenia the next 33 patients receive treatment as in regimen B otherwise patients receive treatment as in regimen A
Treatment for all patients repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients with disease progression limited to CNS only interrupt chemotherapy to have whole-brain radiotherapy WBRT Once WBRT is complete chemotherapy resumes
Quality of life is assessed at baseline and at the beginning of each course of chemotherapy
Patients are followed every 3 months for 2 years and then every 6 months for 3 years
PROJECTED ACCRUAL A total of 49 patients will be accrued for this study within 135 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 |
|---|---|---|---|
| CDR0000069147 | REGISTRY | PDQ Physician Data Query | None |
| NCI-2012-02441 | REGISTRY | None | None |