Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00041249
Status:
COMPLETED
Last Update Posted:
2012-07-18
First Post:
2002-07-08
Brief Title:
Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment
Status:
COMPLETED
Status Verified Date:
2012-07
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 study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen
PURPOSE Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen
Detailed Description:
OBJECTIVES
Determine the antitumor activity of brostallicin in terms of objective response in patients with locally advanced or metastatic soft tissue sarcoma who have failed one prior chemotherapy treatment
Determine the time to progression and duration of response in patients treated with this drug
Determine the safety and toxic effects of this drug in these patients
Correlate clinical outcome with whole blood glutathione level in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to tumor tumors other than gastrointestinal stromal tumor GIST vs GIST
Patients receive brostallicin IV over 10 minutes on day 1 Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 4 months for 1 year
PROJECTED ACCRUAL A total of 58-72 patients 40 for stratum I and 18-32 for stratum II will be accrued for this study
Determine the antitumor activity of brostallicin in terms of objective response in patients with locally advanced or metastatic soft tissue sarcoma who have failed one prior chemotherapy treatment
Determine the time to progression and duration of response in patients treated with this drug
Determine the safety and toxic effects of this drug in these patients
Correlate clinical outcome with whole blood glutathione level in patients treated with this drug
OUTLINE This is a multicenter study Patients are stratified according to tumor tumors other than gastrointestinal stromal tumor GIST vs GIST
Patients receive brostallicin IV over 10 minutes on day 1 Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 4 months for 1 year
PROJECTED ACCRUAL A total of 58-72 patients 40 for stratum I and 18-32 for stratum II will be accrued for this study
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 |
|---|---|---|---|
| EORTC-62011 | None | None | None |