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

Alternate Title

Caspofungin Acetate in Treating Aspergillosis in Patients With Hematologic Cancer or in Patients Who Have Undergone a Stem Cell Transplant

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Active 18 and over Other EORTC-65041 EUDRACT-2004-002944-90, NCT00110045

Objectives

Primary

1. 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

1. Determine the 84-day response rate in patients treated with this drug.
2. Determine the 84-day survival rate in patients treated with this drug.
3. 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.

Entry Criteria

Disease Characteristics:

• Diagnosis of proven or probable invasive aspergillosis (IA)
  • Patients with a diagnosis of possible IA are eligible provided they are upgraded to probable or proven IA by culture and/or histology results and Aspergillus galactomannan evaluation within 7 days after study entry



• Meets any of the following criteria:
  • Diagnosis of a hematologic malignancy
  • Underwent autologous or allogeneic hematopoietic stem cell transplantation

Prior/Concurrent Therapy:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Prior empirical antifungal therapy allowed provided treatment duration was ≤ 72 hours
• Prior prophylactic oral antifungals allowed
• Prior prophylactic IV fluconazole allowed
• More than 14 days since prior and no concurrent investigational agents
• No prior participation in this study
• No prior echinocandins
• No other concurrent antifungal therapy

Patient Characteristics:

Age

• 18 and over

Performance status

• Karnofsky 20-100%

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• AST and ALT ≤ 5 times upper limit of normal (ULN)
• Bilirubin ≤ 5 times ULN
• Alkaline phosphatase ≤ 5 times ULN
• No severe hepatic insufficiency
  • Child-Pugh score ≤ 9

Renal

• No severe renal failure requiring hemodialysis or peritoneal dialysis
• Creatinine < 3.4 mg/dL

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective double-method contraception
• No known HIV positivity
• No history of allergy or adverse reaction to echinocandin drugs
• No known bacterial infection that is not adequately treated
• No psychological, familial, social, or geographical condition that would preclude study participation or compliance

Expected Enrollment

A total of 149 patients (87 in stratum 1, 62 in stratum 2) will be accrued for this study within 18 months.

Outcomes

Response rate as assessed by standard criteria after completion of study treatment

Response rate as assessed by standard and alternative criteria at 84 days and after completion of study treatment
Survival rate at 84 days
Safety

Outline

This is an open-label, multicenter study. Patients are stratified according to disease and/or 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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Claudio Viscoli, MD, Protocol chair		Ph: 39-10-555-5121

Belgium
	Liege
	CHU Liege - Domaine Universitaire du Sart Tilman
		Contact Person	Ph:  32-4-366-7111
France
	Creteil
	Centre Hospitalier Universitaire Henri Mondor
		Contact Person	Ph:  33-1-49-812-590
	Lyon
	Hopital Edouard Herriot - Lyon
		Contact Person	Ph:  33-4-7211-7401
	Paris
	Hopital Saint-Louis
		Contact Person	Ph:  33-1-4249-4949
	Strasbourg
	Hopital Universitaire Hautepierre
		Contact Person	Ph:  33-388-127-682
Germany
	Wuerzburg
	Medizinische Poliklinik, Universitaet Wuerzburg
		Contact Person
Italy
	Cuneo
	Ospedale Santa Croce
		Contact Person	Ph:  39-0171-441-309
	Genoa
	Istituto Nazionale per la Ricerca sul Cancro
		Claudio Viscoli, MD	Ph:  39-10-555-5121
	Ospedale San Martino
		Contact Person	Ph:  39-10-560-0665
	Rome
	Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
		Contact Person	Ph:  39-06-30-15-55-56
Slovakia
	Bratislava
	National Cancer Institute - Bratislava
		Contact Person	Ph:  421-2-5477-2362
Switzerland
	Lausanne
	Centre Hospitalier Universitaire Vaudois
		Contact Person	Ph:  41-21-314-0150
Turkey
	Ankara
	Hacettepe University - Faculty of Medicine
		Contact Person	Ph:  90-312-305-1080

Registry Information
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)
Trial Start Date		2005-02-23
Registered in ClinicalTrials.gov		NCT00110045
Date Submitted to PDQ		2005-03-02
Information Last Verified		2008-04-13