Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Liposomal Doxorubicin in Treating Patients With Stage IIB, Stage IVA, or Stage IVB Recurrent or Refractory Mycosis Fungoides

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Over 18	Other	EORTC-21012 NCT00074087, EUDRACT-2004-001746-32

Objectives

Primary

1. 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

1. Determine the time to progression and duration of response in patients treated with this drug.
2. Determine the toxicity of this drug in these patients.

Entry Criteria

Disease Characteristics:

• Histologically confirmed mycosis fungoides
  • Stage IIB, IVA, or IVB



• Refractory or recurrent disease after at least 2 of the following prior therapies:
  • Local and/or systemic steroids
  • Retinoids
  • Interferon alfa
  • Local carmustine
  • Systemic chemotherapy
  • Psoralen and ultraviolet A (PUVA) light therapy



• No CNS involvement



• No erythroderma (T4)

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics
• More than 2 weeks since prior immunotherapy

Chemotherapy

• See Disease Characteristics
• Prior systemic chemotherapy allowed provided all of the following conditions are met:
  • Cumulative anthracycline dose is less than 200 mg/m²
  • No allergy to anthracyclines
  • Prior methotrexate is low dose (i.e., weekly dose less than 30 mg)
• More than 2 weeks since prior chemotherapy

Endocrine therapy

• See Disease Characteristics
• No concurrent systemic steroids

Radiotherapy

• More than 2 weeks since prior radiotherapy

Surgery

• Not specified

Other

• Recovered from toxic effects of prior therapy, excluding alopecia
• No other concurrent anticancer therapy

Patient Characteristics:

Age

• Over 18

Performance status

• Karnofsky 60-100%

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count at least 1,500/mm³
• WBC at least 2,000/mm³
• Platelet count at least 75,000/mm³
• Hemoglobin at least 10 g/dL

Hepatic

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• SGOT and SGPT no greater than 2.5 times ULN

Renal

• Creatinine no greater than 1.5 times ULN

Cardiovascular

• LVEF normal by echocardiography or radionuclide angiocardiography

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for at least 2 years after study participation
• No psychological, familial, sociological, or geographical condition that would preclude study compliance or follow-up
• No active infection requiring specific therapy (e.g., antibiotics or anti-HIV therapy)
• No other prior or concurrent primary malignant tumor except adequately treated carcinoma in situ of the cervix or squamous cell or basal cell skin cancer

Expected Enrollment

A total of 48 patients will be accrued for this study within 1 year.

Outcomes

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

Time to progression measured by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 weeks during treatment
Duration of response measured by Tumor Burden Index for cutaneous disease and appearance or disappearance of lesions for noncutaneous disease every 8 weeks during treatment and then every 12 weeks until progression
Toxicity assessed by CTC v.2.0 at the end of each course

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/m² has been reached (including anthracyclines from prior treatment).

Patients are followed every 12 weeks until disease progression.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Reinhard Dummer, MD, Study coordinator		Ph: 41-44-255-2507 Email: reinhard.dummer@usz.ch

Austria
	Graz
	Karl-Franzens-University Graz
		Contact Person	Ph:  43-316-380-4100
	Vienna
	Allgemeines Krankenhaus - Universitatskliniken
		Contact Person	Ph:  43-1-40-400
Germany
	Essen
	Universitaetsklinikum Essen
		Contact Person	Ph:  49-201-723-2321
	Jena
	Klinikum der Friedrich-Schiller Universitaet Jena
		Contact Person	Ph:  49-3641-933-114
	Mannheim
	Klinikum der Stadt Mannheim
		Contact Person	Ph:  49-621-383-3833
	Minden
	Klinikum Minden
		Contact Person	Ph:  49-571-801-4810
	Wuerzburg
	Julius Maximilians Universitaet Hospital
		Contact Person	Ph:  49-9-312-012-3756
Israel
	Haifa
	Rambam Medical Center
		Contact Person	Ph:  972-4-854-3003
Italy
	Turin
	Universita di Torino
		Contact Person	Ph:  39-011-670-5955
Switzerland
	Zurich
	UniversitaetsSpital Zuerich
		Contact Person	Ph:  41-1-255-1111
United Kingdom
England
	London
	St. Thomas' Hospital
		Contact Person	Ph:  44-171-922-8009

Registry Information
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
Trial Start Date		2003-10-22
Registered in ClinicalTrials.gov		NCT00074087
Date Submitted to PDQ		2003-10-23
Information Last Verified		2009-07-22

Back to Top