Daptomycin in Treating Neutropenia and Fever in Patients With Cancer

NCT ID: NCT00335478

Last Updated: 2017-05-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-12-31
• Study Completion Date: 2008-10-31

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.

Conditions

Fever; Sweating; Hot Flashes; Infection; Neutropenia; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Daptomycin

Group Type: EXPERIMENTAL

Daptomycin

Intervention Type: DRUG

daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is \>500 cells/mm\^3.

Interventions

Daptomycin

daptomycin 6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is \>500 cells/mm\^3.

Intervention Type: DRUG

Other Intervention Names

Cubicin

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OHSU Knight Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Joseph Bubalo

PharmD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Bubalo, PharmD

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

OHSU Knight Cancer Institute

Portland, Oregon, United States

Countries

United States

Other Identifiers

OHSU-CPC-05052-L

Identifier Type: OTHER

Identifier Source: secondary_id

OHSU-1321

Identifier Type: OTHER

Identifier Source: secondary_id

CUBIST-OHSU-CPC-05052-L

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000476568

Identifier Type: -

Identifier Source: org_study_id