Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
Condition: Fever; Sweating; Hot Flashes; Infection; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Neutropenia; Fever; Hot Flashes
Intervention: Daptomycin
Intervention description: daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
Intervention MeSH terms: Daptomycin
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Maximum age: 99 Years
Healthy volunteers: No
Keywords: neutropenia; infection; unspecified adult solid tumor, protocol specific; fever, sweats, and hot flashes

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.
    

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