Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025272
Status:
COMPLETED
Last Update Posted:
2021-09-09
First Post:
2001-10-11
Brief Title:
Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Phase II Study of Sequential Topotecan-Carboplatin-Etoposide in Patients With Extensive Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2021-09
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 and giving them in different ways may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining topotecan carboplatin and etoposide in treating patients who have extensive-stage small cell lung cancer
PURPOSE Phase II trial to study the effectiveness of combining topotecan carboplatin and etoposide in treating patients who have extensive-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Determine the toxicity profile and maximum tolerated dose of sequential topotecan carboplatin and etoposide in patients with chemotherapy-naive extensive stage small cell lung cancer Phase I closed to accrual as of 04042003
Determine the response rate and duration of response in patients with treated with this regimen
Determine the failure-free and overall survival of patients treated with this regimen
Determine the pharmacokinetics and pharmacodynamics of topotecan and etoposide on this schedule in these patients
OUTLINE This is a dose-escalation multicenter study of topotecan and etoposide Phase I closed to accrual as of 04042003
Patients receive oral topotecan on days 1-5 carboplatin IV over 30 minutes on day 6 and oral etoposide on days 6-10 Treatment continues every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients with complete response CR or partial response after the second course receive up to 4 additional courses Patients with brain metastases at initial presentation undergo whole-brain irradiation before the chemotherapy regimen Patients without brain metastases at initial presentation who achieve CR undergo prophylactic whole-brain irradiation
Sequential dose escalation of topotecan is followed by sequential dose escalation of etoposide Cohorts of 3-6 patients receive escalating doses of topotecan and then etoposide until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Phase I closed to accrual as of 04042003 In the phase II part of study an additional 11-40 patients are accrued to receive topotecan carboplatin and etoposide at the MTD
Patients are followed every 3 months
PROJECTED ACCRUAL A maximum of 50 patients 3-10 for phase I and 11-40 for phase II will be accrued for this study Phase I closed to accrual as of 04042003
Determine the toxicity profile and maximum tolerated dose of sequential topotecan carboplatin and etoposide in patients with chemotherapy-naive extensive stage small cell lung cancer Phase I closed to accrual as of 04042003
Determine the response rate and duration of response in patients with treated with this regimen
Determine the failure-free and overall survival of patients treated with this regimen
Determine the pharmacokinetics and pharmacodynamics of topotecan and etoposide on this schedule in these patients
OUTLINE This is a dose-escalation multicenter study of topotecan and etoposide Phase I closed to accrual as of 04042003
Patients receive oral topotecan on days 1-5 carboplatin IV over 30 minutes on day 6 and oral etoposide on days 6-10 Treatment continues every 3 weeks for 2 courses in the absence of disease progression or unacceptable toxicity Patients with complete response CR or partial response after the second course receive up to 4 additional courses Patients with brain metastases at initial presentation undergo whole-brain irradiation before the chemotherapy regimen Patients without brain metastases at initial presentation who achieve CR undergo prophylactic whole-brain irradiation
Sequential dose escalation of topotecan is followed by sequential dose escalation of etoposide Cohorts of 3-6 patients receive escalating doses of topotecan and then etoposide until the maximum tolerated dose MTD of the combination is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity Phase I closed to accrual as of 04042003 In the phase II part of study an additional 11-40 patients are accrued to receive topotecan carboplatin and etoposide at the MTD
Patients are followed every 3 months
PROJECTED ACCRUAL A maximum of 50 patients 3-10 for phase I and 11-40 for phase II will be accrued for this study Phase I closed to accrual as of 04042003
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 |
|---|---|---|---|
| NCI-5333 | None | None | None |
| CCCWFU-62300 | None | None | None |