Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003283
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Octreotide With or Without Prednisone in Treating Patients With Metastatic or Recurrent Thymoma
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Study of Octreotide Treatment of Advanced Recurrent Thymoma
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
PURPOSE Phase II trial to compare the effectiveness of octreotide alone or with prednisone in treating patients with metastatic or recurrent thymoma
PURPOSE Phase II trial to compare the effectiveness of octreotide alone or with prednisone in treating patients with metastatic or recurrent thymoma
Detailed Description:
OBJECTIVES I Determine the objective response rate in patients with metastatic or recurrent thymoma treated with octreotide II Determine the duration of remission in these patients III Determine the toxicity of the octreotide regimen in this population IV Determine the response rate duration of remission survival and toxicity of prednisone added to octreotide in patients with stable disease following octreotide alone
OUTLINE All patients receive octreotide subcutaneously three times daily for 1 month After two courses of treatment patients are assessed for response Patients experiencing partial or complete response continue octreotide for a maximum of 1 year 12 courses in the absence of unacceptable toxicity or disease progression Patients with stable disease after 2 courses of octreotide receive daily oral prednisone in addition to octreotide for an additional 2 courses These patients are then reevaluated and continue on octreotide plus prednisone for a maximum of 1 year in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 1 year every 4 months for the second year every 6 months for the next 3 years and then annually thereafter
PROJECTED ACCRUAL There will be 38 patients accrued into this study over approximately 2 years
OUTLINE All patients receive octreotide subcutaneously three times daily for 1 month After two courses of treatment patients are assessed for response Patients experiencing partial or complete response continue octreotide for a maximum of 1 year 12 courses in the absence of unacceptable toxicity or disease progression Patients with stable disease after 2 courses of octreotide receive daily oral prednisone in addition to octreotide for an additional 2 courses These patients are then reevaluated and continue on octreotide plus prednisone for a maximum of 1 year in the absence of unacceptable toxicity or disease progression Patients are followed every 3 months for 1 year every 4 months for the second year every 6 months for the next 3 years and then annually thereafter
PROJECTED ACCRUAL There will be 38 patients accrued into this study over approximately 2 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 |
|---|---|---|---|
| E-1C97 | None | None | None |