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Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

Primary Purpose

Fever, Sweating, Hot Flashes

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Daptomycin
Sponsored by
OHSU Knight Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Fever focused on measuring neutropenia, infection, unspecified adult solid tumor, protocol specific, fever, sweats, and hot flashes

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • OHSU Knight Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Daptomycin

Arm Description

Outcomes

Primary Outcome Measures

Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.
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.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2006
Last Updated
May 7, 2017
Sponsor
OHSU Knight Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00335478
Brief Title
Daptomycin in Treating Neutropenia and Fever in Patients With Cancer
Official Title
Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
December 2006 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
OHSU Knight Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 neutropenia and fever in patients with cancer.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fever, Sweating, Hot Flashes, Infection, Neutropenia, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
neutropenia, infection, unspecified adult solid tumor, protocol specific, fever, sweats, and hot flashes

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Daptomycin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Daptomycin
Other Intervention Name(s)
Cubicin
Intervention Description
daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
Primary Outcome Measure Information:
Title
Number of Participants Who Became Afebrile Within 72 Hours of Starting Daptomycin.
Description
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.
Time Frame
Within 72 hours of starting daptomycin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Bubalo, PharmD
Organizational Affiliation
OHSU Knight Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OHSU Knight Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States

12. IPD Sharing Statement

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Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

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