Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

• Status: Completed
• Trial end date: 2008-10-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Antibiotics, such as daptomycin, may control neutropenia, fever, and infection in patients with cancer.

PURPOSE: This phase II trial is studying how well daptomycin works in treating neutropenia and fever in patients with cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: OHSU Knight Cancer Institute
• Treatments: Daptomycin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of cancer

• Diagnosis of neutropenic fever

• Temperature > 38.3°C once OR ≥ 38°C twice within 12 hours

• Absolute neutrophil count < 500/mm^³ and ≥ 1 of the following:

• Mucositis

• Concurrent skin or soft tissue infection

• Indwelling catheter and/or suspected catheter infection

• Recent quinolone prophylaxis

• Positive blood cultures for gram-positive cocci before final identification or other documented gram-positive pathogen

• Colonization with β-lactam resistant gram-positive organisms (commonly the nares or the skin)

• Hypotension, tachycardia, narrowed pulse pressures, tachypnea, or other signs of cardiovascular compromise

• Expected duration of neutropenia ≥ 3 days

• No known infection with daptomycin-resistant organism or gram-negative organism and not yet meeting criteria for the addition of gram-positive antimicrobial therapy

• No suspected meningitis or osteomyelitis

• No documented or suspected gram-positive pneumonia

• No suspected or proven endocarditis

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-2

• Life expectancy ≥ 2 weeks

• Creatinine clearance ≥ 50 mL/min

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective double-method contraception

• No known sensitivity to daptomycin or product excipients

• No history of or concurrent rhabdomyolysis

• No HIV positivity

• No psychiatric disorders that would preclude study compliance

• No signs or symptoms of myopathy with creatine phosphokinase (CPK) elevation > 1,000 U/L (5 times upper limit of normal [ULN])

• No CPK elevations > 10 times ULN in patients with no signs or symptoms of myopathy

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• At least 7 days since prior daptomycin or other antibiotic agents covering gram-positive organisms

• No concurrent hemodialysis or continuous ambulatory peritoneal dialysis

• No concurrent succinylcholine, ethanol, fludrocortisone, olanzapine, or pioglitazone

• No concurrent hydroxymethyl glutaryl (HMG) coenzyme A (HMG CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin)

• Concurrent therapy for gram-negative bacterial infection allowed