Daptomycin in Treating Neutropenia and Fever in Patients With Cancer - Full Text View

Sponsors and Collaborators:	Oregon Health and Science University Cancer Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00335478

Purpose

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.

Condition	Intervention	Phase
Cancer-Related Problem/Condition Unspecified Adult Solid Tumor, Protocol Specific	Drug: daptomycin	Phase II

MedlinePlus related topics: Cancer Fever

Drug Information available for: Daptomycin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Open Label
Official Title:	Phase II Open Label Pilot Trial of Empiric Daptomycin Treatment for Oncology Patients With Neutropenic Fever

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Response rate within 72 hours of starting treatment [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of bacterial cures [ Designated as safety issue: No ]
Time to afebrile state [ Designated as safety issue: No ]
Pharmacokinetics [ Designated as safety issue: No ]
Incidence of breakthrough infections [ Designated as safety issue: Yes ]
Tolerability [ Designated as safety issue: Yes ]
Adverse events and toxicity [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	December 2006
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

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 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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/mm³ 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:

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 coenzyme A (HMG CoA) reductase inhibitors (e.g., lovastatin, simvastatin, atorvastatin)
Concurrent therapy for gram-negative bacterial infection allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00335478

Locations

United States, Oregon
Oregon Health & Science University Cancer Institute
Portland, Oregon, United States, 97239

Sponsors and Collaborators

Oregon Health and Science University Cancer Institute

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Joseph Bubalo, PharmD, BCPS, BCOP

Oregon Health and Science University Cancer Institute

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	Oregon Health and Science University Cancer Institute ( Joseph Bubalo )
Study ID Numbers:	CDR0000476568, OHSU-CPC-05052-L, OHSU-1321, CUBIST-OHSU-CPC-05052-L
Study First Received:	June 8, 2006
Last Updated:	November 1, 2008
ClinicalTrials.gov Identifier:	NCT00335478
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

neutropenia
infection
unspecified adult solid tumor, protocol specific
fever, sweats, and hot flashes

Study placed in the following topic categories:

Daptomycin
Fever
Neutropenia
Hot Flashes

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009