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Tracking Information | |||||
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First Received Date † | December 10, 2003 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date † | October 2003 | ||||
Current Primary Outcome Measures † |
Response (complete clinical [CCR] and partial resp. [PR]) rate by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 wks during treatment and then every 12 wks until progression [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00074087 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † |
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Descriptive Information | |||||
Brief Title † | Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides | ||||
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 | ||||
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. |
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Detailed Description | OBJECTIVES: Primary
Secondary
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 anthracycline(s) dose of 400 mg/m^2 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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † | Lymphoma | ||||
Intervention † | Drug: pegylated liposomal doxorubicin hydrochloride | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Recruiting | ||||
Enrollment † | 48 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Both | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Austria, Germany, Italy, Switzerland, United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00074087 | ||||
Responsible Party | |||||
Secondary IDs †† | EORTC-21012, EUDRACT-2004-001746-32 | ||||
Study Sponsor † | European Organization for Research and Treatment of Cancer | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | April 2008 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |