Ignite Creation Date:
2024-05-05 @ 11:44 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00110045
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2005-05-03
Brief Title:
Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
A Multicenter Open Phase II Study to Estimate the Activity and Safety of Caspofungin CASP in the First-Line Treatment of Probable and Proven Invasive Aspergillosis IA in Patients With Hematological Malignancies HM or Recipients of Autologous Haematopoietic Stem Cell Transplantation and Those With Allogeneic Haematopoietic Stem Cell Transplantation HSCT
Status:
COMPLETED
Status Verified Date:
2012-09
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 Antifungals such as caspofungin acetate may be effective in treating fungal infections caused by chemotherapy or stem cell transplant
PURPOSE This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant
PURPOSE This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant
Detailed Description:
OBJECTIVES
Primary
Determine the activity of caspofungin acetate as first-line therapy for proven or probable invasive aspergillosis in terms of response rate in patients with hematologic malignancies or in patients who have undergone hematopoietic stem cell transplantation
Secondary
Determine the 84-day response rate in patients treated with this drug
Determine the 84-day survival rate in patients treated with this drug
Determine the safety of this drug in terms of the rate of overall drug-related adverse events the rate of overall drug-related serious adverse events and the rate of drug-related adverse events leading to treatment discontinuation in these patients
OUTLINE This is an open-label multicenter study Patients are stratified according to disease andor type of prior hematopoietic stem cell transplantation HSCT hematologic malignancy or autologous HSCT vs allogeneic HSCT
Patients receive caspofungin acetate IV over approximately 1 hour once daily on days 1-15 in the absence of disease progression or unacceptable toxicity
Patients achieving a complete response CR or partial response PR after day 15 may continue to receive caspofungin acetate as above until day 84 OR discontinue study treatment after day 15 and shift to an oral antifungal drug for maintenance therapy or prophylaxis if considered to be in the best interest of the patient Patients achieving stable disease after day 15 continue to receive caspofungin acetate as above until day 28 These patients then undergo a second evaluation Patients who maintain stable disease continue to receive caspofungin acetate as above until day 84 Patients achieving CR or PR are treated as per CR or PR treatment described above
After completion of study treatment patients are followed weekly for 30 days
PROJECTED ACCRUAL A total of 149 patients 87 in stratum 1 62 in stratum 2 will be accrued for this study within 18 months
Primary
Determine the activity of caspofungin acetate as first-line therapy for proven or probable invasive aspergillosis in terms of response rate in patients with hematologic malignancies or in patients who have undergone hematopoietic stem cell transplantation
Secondary
Determine the 84-day response rate in patients treated with this drug
Determine the 84-day survival rate in patients treated with this drug
Determine the safety of this drug in terms of the rate of overall drug-related adverse events the rate of overall drug-related serious adverse events and the rate of drug-related adverse events leading to treatment discontinuation in these patients
OUTLINE This is an open-label multicenter study Patients are stratified according to disease andor type of prior hematopoietic stem cell transplantation HSCT hematologic malignancy or autologous HSCT vs allogeneic HSCT
Patients receive caspofungin acetate IV over approximately 1 hour once daily on days 1-15 in the absence of disease progression or unacceptable toxicity
Patients achieving a complete response CR or partial response PR after day 15 may continue to receive caspofungin acetate as above until day 84 OR discontinue study treatment after day 15 and shift to an oral antifungal drug for maintenance therapy or prophylaxis if considered to be in the best interest of the patient Patients achieving stable disease after day 15 continue to receive caspofungin acetate as above until day 28 These patients then undergo a second evaluation Patients who maintain stable disease continue to receive caspofungin acetate as above until day 84 Patients achieving CR or PR are treated as per CR or PR treatment described above
After completion of study treatment patients are followed weekly for 30 days
PROJECTED ACCRUAL A total of 149 patients 87 in stratum 1 62 in stratum 2 will be accrued for this study within 18 months
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 |
|---|---|---|---|
| EUDRACT-2004-002944-90 | None | None | None |
| EORTC-65041 | None | None | None |