Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00010257
Status:
COMPLETED
Last Update Posted:
2023-06-29
First Post:
2001-02-02
Brief Title:
Carboplatin Combined With Paclitaxel in Treating Patients With Advanced Thymoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study Of Carboplatin Plus Paclitaxel Treatment Of Advanced Thymoma Or Thymic Carcinoma
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 chemotherapy drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma
PURPOSE Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma
Detailed Description:
OBJECTIVES
Determine the objective response rate in patients with advanced thymoma or thymic carcinoma treated with carboplatin and paclitaxel
Determine the duration of response in these patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel by intravenous IV infusion over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 2 courses in the absence of disease progression Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses Further treatment may be given at the discretion of the treating physician
Patients were followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 35-68 patients were to be accrued for this study within 38-46 years
Determine the objective response rate in patients with advanced thymoma or thymic carcinoma treated with carboplatin and paclitaxel
Determine the duration of response in these patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE Patients receive paclitaxel by intravenous IV infusion over 3 hours followed by carboplatin IV over 30 minutes on day 1 Treatment repeats every 21 days for 2 courses in the absence of disease progression Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses Further treatment may be given at the discretion of the treating physician
Patients were followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 35-68 patients were to be accrued for this study within 38-46 years
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 |
|---|---|---|---|
| E1C99 | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |
| U10CA021115 | NIH | None | None |