Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
Fever, Sweating, Hot Flashes
About this trial
This is an interventional supportive care trial for Fever focused on measuring neutropenia, infection, unspecified adult solid tumor, protocol specific, fever, sweats, and hot flashes
Eligibility 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
Sites / Locations
- OHSU Knight Cancer Institute
Arms of the Study
Arm 1
Experimental
Daptomycin