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Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT00335478
First received: June 8, 2006
Last updated: May 24, 2012
Last verified: July 2011

June 8, 2006
May 24, 2012
December 2006
October 2008   (final data collection date for primary outcome measure)
Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin. [ Time Frame: Within 72 hours of starting daptomycin ] [ Designated as safety issue: No ]

If after 72 hours of daptomycin treatment, the patient is afebrile and has absolute neutrophil count (ANC) >500 cells/mm^3 for 48 hours with no site of infection, negative cultures, and no clinical indications for therapy, the antibiotic regimen will be discontinued.

Complete Response: Resolution of fever and clinical signs/symptoms of infection.

Partial Response: Resolution of fever without resolution of clinical signs of infection.

Not Provided
Complete list of historical versions of study NCT00335478 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever

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.

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 patients with documented gram-positive bacterial infections.
  • Assess time to afebrile state.
  • Assess the pharmacokinetic data of daptomycin in neutropenic patients.
  • Document the incidence of breakthrough infections that require a change of therapy or additional agents to clear.
  • Assess the tolerability of daptomycin in neutropenic patients.
  • Assess and document adverse events and toxicity due to daptomycin.

OUTLINE: This is an open-label, pilot study.

Patients first receive standard treatment for gram-negative bacteria for 72 hours. If the patient is still febrile at 72 hours, daptomycin is administered.

Patients receive daptomycin IV over 30 minutes once daily. Patients who are afebrile, not neutropenic (absolute neutrophil count [ANC] > 500/mm³), and have no signs of infection after 72 hours of therapy may discontinue daptomycin. Patients who are afebrile and neutropenic (ANC < 500/mm³) after 72 hours of therapy continue to receive daptomycin until absolute neutrophil count (ANC) > 500/mm³ for 2 consecutive days. Patients who are febrile with or without continued neutropenia (ANC < 500/mm³) after 72 hours of therapy continue to receive daptomycin for up to 10-14 days in the absence of unacceptable toxicity.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Fever
  • Sweating
  • Hot Flashes
  • Infection
  • Neutropenia
  • Unspecified Adult Solid Tumor, Protocol Specific
Drug: Daptomycin
daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
Other Name: Cubicin
Experimental: Daptomycin
Intervention: Drug: Daptomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
October 2008
October 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00335478
CDR0000476568, OHSU-CPC-05052-L, OHSU-1321, CUBIST-OHSU-CPC-05052-L
Yes
OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
Not Provided
Principal Investigator: Joseph Bubalo, PharmD OHSU Knight Cancer Institute
OHSU Knight Cancer Institute
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP