Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003696
Status:
UNKNOWN
Last Update Posted:
2013-09-17
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients Who Have Extensive-Stage Small Cell Lung Cancer
Sponsor:
Commissie Voor Klinisch Toegepast Onderzoek
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Study of Cyclophosphamide Doxorubicin and Etoposide Compared to Carboplatin and Taxol in Patients With Extensive Disease Small Cell Lung Cancer
Status:
UNKNOWN
Status Verified Date:
2001-11
Last Known Status:
ACTIVE_NOT_RECRUITING
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 most effective for extensive-stage small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer
PURPOSE Randomized phase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients with extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Compare the effect of cyclophosphamide doxorubicin and etoposide with carboplatin and paclitaxel on progression free survival in patients with extensive stage small cell lung cancer
Compare the overall survival response rate duration of response and toxic effects of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to institute and performance status 0-1 vs 2-3
Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cyclophosphamide IV and doxorubicin IV on day 1 and etoposide IV on days 1-3 every 3 weeks
Arm II Patients receive carboplatin IV followed by paclitaxel IV over 3 hours on day 1 every 3 weeks
Patients with stable or responding disease are treated for up to 5 courses
Patients are followed every 4 weeks
PROJECTED ACCRUAL A total of 250 patients 125 per treatment arm will be accrued within 24 months for this study
Compare the effect of cyclophosphamide doxorubicin and etoposide with carboplatin and paclitaxel on progression free survival in patients with extensive stage small cell lung cancer
Compare the overall survival response rate duration of response and toxic effects of these regimens in these patients
OUTLINE This is a randomized study Patients are stratified according to institute and performance status 0-1 vs 2-3
Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive cyclophosphamide IV and doxorubicin IV on day 1 and etoposide IV on days 1-3 every 3 weeks
Arm II Patients receive carboplatin IV followed by paclitaxel IV over 3 hours on day 1 every 3 weeks
Patients with stable or responding disease are treated for up to 5 courses
Patients are followed every 4 weeks
PROJECTED ACCRUAL A total of 250 patients 125 per treatment arm will be accrued within 24 months for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-98059 | None | None | None |
| CKVO-9802 | None | None | None |
| DUT-KWF-CKVO-9802 | None | None | None |