Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017186
Status:
COMPLETED
Last Update Posted:
2016-12-07
First Post:
2001-06-06
Brief Title:
Gemcitabine and Epirubicin in Treating Patients With Malignant Mesothelioma
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
Phase II Study of Gemcitabine and Epirubicin for the Treatment of Mesothelioma
Status:
COMPLETED
Status Verified Date:
2016-12
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 may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma
PURPOSE Phase II trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma
Detailed Description:
OBJECTIVES
Determine the antitumor activity of gemcitabine and epirubicin in patients with malignant pleural mesothelioma
Determine the toxicity of this regimen in this patient population
Determine the time to progression and overall survival of patients treated with this regimen
Assess quality of life in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond CR
Quality of life is assessed at baseline prior to course 3 at 3 months and then at 1 year
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 years
Determine the antitumor activity of gemcitabine and epirubicin in patients with malignant pleural mesothelioma
Determine the toxicity of this regimen in this patient population
Determine the time to progression and overall survival of patients treated with this regimen
Assess quality of life in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and epirubicin IV on day 1 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity Patients achieving complete response CR receive 2 additional courses beyond CR
Quality of life is assessed at baseline prior to course 3 at 3 months and then at 1 year
Patients are followed every 3 months for 1 year every 4 months for 1 year and then every 6 months for 3 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 |
|---|---|---|---|
| CDR0000068659 | REGISTRY | NCI Physician Data Query | None |
| NCCTG-N0021 | None | None | None |