Status:
COMPLETED
Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
Lead Sponsor:
OHSU Knight Cancer Institute
Conditions:
Fever
Sweating
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief 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 neutr...
Detailed Description
OBJECTIVES: Primary * Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever. Secondary * Assess the percentage of bacterial cures in ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00335478
Start Date
December 1 2006
End Date
October 1 2008
Last Update
May 9 2017
Active Locations (1)
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1
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239