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

Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00110045
• Other study ID #: EORTC-65041
• Secondary ID: EORTC-65041EUDRA
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2005
• Last updated: September 20, 2012
• Start date: February 2005

Study information

• Verified date: September 2012
• Source: European Organisation for Research and Treatment of Cancer - EORTC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Antifungals, such as caspofungin acetate, may be effective in treating fungal infections caused by chemotherapy or stem cell transplant.

PURPOSE: This phase II trial is studying how well caspofungin acetate works as first-line treatment for aspergillosis in patients with hematologic cancer or in patients who have undergone a stem cell transplant.

Description:

OBJECTIVES:

Primary

• 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

• Determine the 84-day response rate in patients treated with this drug.

• Determine the 84-day survival rate in patients treated with this drug.

• 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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 171
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

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

Study Design

Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Aspergillosis
• Cancer

Intervention

Drug:
• caspofungin acetate

Locations

Country	Name	City	State
Belgium	CHU Liege - Domaine Universitaire du Sart Tilman	Liege
France	Centre Hospitalier Universitaire Henri Mondor	Creteil
France	Hopital Edouard Herriot - Lyon	Lyon
France	Hopital Saint-Louis	Paris
France	Hopital Universitaire Hautepierre	Strasbourg
Germany	Medizinische Poliklinik, Universitaet Wuerzburg	Wuerzburg
Italy	Ospedale Santa Croce	Cuneo
Italy	Istituto Nazionale per la Ricerca sul Cancro	Genoa
Italy	Ospedale San Martino	Genoa
Italy	Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore	Rome
Slovakia	National Cancer Institute - Bratislava	Bratislava
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne
Turkey	Hacettepe University - Faculty of Medicine	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
European Organisation for Research and Treatment of Cancer - EORTC

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Slovakia,  Switzerland,  Turkey, 

References & Publications (1)

Viscoli C, Herbrecht R, Akan H, Baila L, Sonet A, Gallamini A, Giagounidis A, Marchetti O, Martino R, Meert L, Paesmans M, Ameye L, Shivaprakash M, Ullmann AJ, Maertens J; Infectious Disease Group of the EORTC. An EORTC Phase II study of caspofungin as fi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate as assessed by standard criteria after completion of study treatment
Secondary	Response rate as assessed by standard and alternative criteria at 84 days and after completion of study treatment
Secondary	Survival rate at 84 days
Secondary	Safety