Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
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.
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