Caspofungin Acetate Compared With Amphotericin B Liposomal in Treating Patients With Persistent Fever and Neutropenia Following Cancer Treatment

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Caspofungin acetate or amphotericin B liposomal may be effective in preventing or controlling fever and neutropenia caused by chemotherapy, bone marrow transplantation, or peripheral stem cell transplantation. It is not yet known whether caspofungin acetate or amphotericin B liposomal is more effective for treating these side effects.

PURPOSE: Randomized phase III trial to compare the effectiveness of caspofungin acetate with that of amphotericin B liposomal in treating patients who have persistent fever and neutropenia after receiving anticancer therapy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Amphotericin B; Caspofungin; Echinocandins; Liposomal amphotericin B

Criteria

DISEASE CHARACTERISTICS:

• Leukemia, lymphoma, or other cancer that has been previously treated with chemotherapy or bone marrow or peripheral blood stem cell transplantation

• Absolute neutrophil count less than 500/mm^3 for past 96 hours and not expected to recover in next 48 hours

• Received at least 96 hours of parenteral systemic antibacterial therapy

• Fever greater than 38.0 degrees Celsius

• Adequately managed bacterial infection allowed if all of the following are true:

• Negative blood cultures

• Received at least 5 days of antibiotics to which any bacterial isolates are sensitive

• Surgical drainage of any abscess fluid or surgical debridement of infected tissues

• Removal of infected catheters

• No invasive fungal infection

• Not previously enrolled on this study

PATIENT CHARACTERISTICS:

Age:

• 16 and over

Performance status:

• Karnofsky 30-100%

Life expectancy:

• At least 5 days

Hematopoietic:

• Platelet count at least 5,000/mm^3

• INR no greater than 1.6 (no greater than 4.0 if receiving anticoagulants)

Hepatic:

• Bilirubin no greater than 3 times upper limit of normal (ULN)

• AST or ALT no greater than 5 times ULN

• Alkaline phosphatase no greater than 3 times ULN

• No acute hepatitis or cirrhosis

Renal:

• Not specified

Other:

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective barrier contraception

• No allergy, hypersensitivity, or prior serious reaction to any echinocandin antifungal or amphotericin B formulation

• No other condition or illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• See Disease Characteristics

Chemotherapy:

• See Disease Characteristics

• No concurrent investigational antineoplastic therapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• At least 10 days since prior parenteral amphotericin B

• At least 14 days since prior investigational antibiotic, antifungal, or immunosuppressive drug

• No concurrent rifampin or cyclosporine

• No other concurrent investigational antibiotic, antifungal, or immunosuppressive drug

• No concurrent alcohol