Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
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.
Unspecified Adult Solid Tumor, Protocol Specific
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever|
- 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.
|Study Start Date:||December 2006|
|Study Completion Date:||October 2008|
|Primary Completion Date:||October 2008 (Final data collection date for primary outcome measure)|
daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
Other Name: Cubicin
- Assess the response rate to therapy within 72 hours of starting daptomycin in cancer patients with neutropenic fever.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00335478
|United States, Oregon|
|OHSU Knight Cancer Institute|
|Portland, Oregon, United States, 97239|
|Principal Investigator:||Joseph Bubalo, PharmD||OHSU Knight Cancer Institute|