Ignite Creation Date:
2024-05-05 @ 11:32 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00074087
Status:
COMPLETED
Last Update Posted:
2018-07-09
First Post:
2003-12-10
Brief Title:
Liposomal Doxorubicin in Treating Patients With Stage IIB Stage IVA or Stage IVB Recurrent or Refractory Mycosis Fungoides
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Phase II Clinical Trial With Caelyx Mono-Chemotherapy in Patients With Advanced Mycosis Fungoides Stage IIb IVa and IVb With or Without Previous Chemotherapy
Status:
COMPLETED
Status Verified Date:
2018-07
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 such as liposomal doxorubicin use different ways to stop cancer cells from dividing so they stop growing or die
PURPOSE Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have stage IIB stage IVA or stage IVB recurrent or refractory mycosis fungoides
PURPOSE Phase II trial to study the effectiveness of liposomal doxorubicin in treating patients who have stage IIB stage IVA or stage IVB recurrent or refractory mycosis fungoides
Detailed Description:
OBJECTIVES
Primary
Determine the antitumor activity of doxorubicin HCl liposome in terms of response rate complete response and partial response in patients with stage IIB IVA or IVB recurrent or refractory mycosis fungoides
Secondary
Determine the time to progression and duration of response in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive doxorubicin HCl liposome IV over 1 hour on days 1 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity or until a maximum cumulative anthracyclines dose of 400 mgm2 has been reached including anthracyclines from prior treatment
Patients are followed every 12 weeks until disease progression
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study within 1 year
Primary
Determine the antitumor activity of doxorubicin HCl liposome in terms of response rate complete response and partial response in patients with stage IIB IVA or IVB recurrent or refractory mycosis fungoides
Secondary
Determine the time to progression and duration of response in patients treated with this drug
Determine the toxicity of this drug in these patients
OUTLINE This is an open-label nonrandomized multicenter study
Patients receive doxorubicin HCl liposome IV over 1 hour on days 1 and 15 Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity or until a maximum cumulative anthracyclines dose of 400 mgm2 has been reached including anthracyclines from prior treatment
Patients are followed every 12 weeks until disease progression
PROJECTED ACCRUAL A total of 48 patients will be accrued for this study within 1 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 |
|---|---|---|---|
| 2004-001746-32 | EUDRACT_NUMBER | None | None |