Overview

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