Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003864
Status:
COMPLETED
Last Update Posted:
2023-06-15
First Post:
1999-11-01
Brief Title:
Docetaxel Plus Carboplatin in Treating Patients With Advanced Cancer of the Esophagus
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Phase II Trial of Docetaxel and Carboplatin in Patients With Advanced Squamous Carcinoma of the Esophagus
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 cancer cells from dividing so they stop growing or die Combining more than one drug may kill more cancer cells
PURPOSE Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have advanced cancer of the esophagus
PURPOSE Phase II trial to study the effectiveness of docetaxel plus carboplatin in treating patients who have advanced cancer of the esophagus
Detailed Description:
OBJECTIVES I Evaluate the objective response rate in patients with advanced squamous cell carcinoma of the esophagus treated with carboplatin and docetaxel II Assess the toxicity of this regimen in these patients III Assess the time to progression and overall survival of this patient population
OUTLINE Patients receive docetaxel IV over 1 hour on day 1 followed by carboplatin IV over 15-30 minutes on day 1 Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until year 2 every 6 months during years 2-5 and then annually thereafter until death
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study at a rate of 30 patients per year
OUTLINE Patients receive docetaxel IV over 1 hour on day 1 followed by carboplatin IV over 15-30 minutes on day 1 Treatment is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity Patients are followed every 3 months until year 2 every 6 months during years 2-5 and then annually thereafter until death
PROJECTED ACCRUAL A total of 18-35 patients will be accrued for this study at a rate of 30 patients per year
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-2298 | None | None | None |