Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057837
Status:
COMPLETED
Last Update Posted:
2023-07-05
First Post:
2003-04-07
Brief Title:
Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase II Study Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer SCLC Topotecan Sequenced With EtoposideCisplatin and IrinotecanCisplatin Sequenced With Etoposide
Status:
COMPLETED
Status Verified Date:
2023-06
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 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 It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer
PURPOSE Randomized phase II trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the response frequency of patients with extensive stage small cell lung cancer treated with topotecan cisplatin and etoposide and with irinotecan cisplatin and etoposide
Evaluate the toxic effects of these regimens in these patients
Evaluate the duration of response and survival of patients treated with these regimens
Secondary
To investigate the occurrence of various breast cancer resistance protein BCRP alleles in patients receiving topoisomerase 1 inhibitors and their impact on clinical response and toxicity
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I PET Patients receive topotecan intravenously IV over 30 minutes on days 1-3 etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10 and filgrastim G-CSF subcutaneously daily beginning on day 11 and continuing until blood counts recover
Arm II PIE Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10
In both arms treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
ACTUAL ACCRUAL A total of 140 patients were accrued for this study
Primary
Evaluate the response frequency of patients with extensive stage small cell lung cancer treated with topotecan cisplatin and etoposide and with irinotecan cisplatin and etoposide
Evaluate the toxic effects of these regimens in these patients
Evaluate the duration of response and survival of patients treated with these regimens
Secondary
To investigate the occurrence of various breast cancer resistance protein BCRP alleles in patients receiving topoisomerase 1 inhibitors and their impact on clinical response and toxicity
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm I PET Patients receive topotecan intravenously IV over 30 minutes on days 1-3 etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10 and filgrastim G-CSF subcutaneously daily beginning on day 11 and continuing until blood counts recover
Arm II PIE Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10
In both arms treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years and then every 6 months for 1 year
ACTUAL ACCRUAL A total of 140 patients were accrued for this study
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 |
|---|---|---|---|
| E5501 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |