Early Hospital Discharge or Standard Inpatient Care in Cancer Patients Receiving Antibiotics for Febrile Neutropenia

Study Description

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Brief Summary:

RATIONALE: Finishing an antibiotic regimen at home may be as effective as receiving it in the hospital. It is not yet known whether early hospital discharge is as effective as standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.

PURPOSE: This randomized phase III trial is studying early hospital discharge and comparing it with standard inpatient care in cancer patients receiving antibiotics for febrile neutropenia.

Condition or disease	Intervention/treatment	Phase
Brain and Central Nervous System Tumors; Lymphoma; Neutropenia; Psychosocial Effects of Cancer and Its Treatment; Small Intestine Cancer; Unspecified Adult Solid Tumor, Protocol Specific	Drug: amoxicillin-clavulanate potassium; Drug: ciprofloxacin; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment	Phase 3

Detailed Description:

OBJECTIVES:

• Identify cancer patients who are low-risk inpatients and meet criteria for early discharge (i.e., symptomatic improvement and temperature ≤ 37.8°C) after receiving oral antibiotics for febrile neutropenia.

OUTLINE: This is a randomized, prospective, multicenter study. Patients are stratified by disease type (lymphoma vs solid tumor), duration of registration (< 48 hours vs > 48 hours), and participating center.

Patients receive oral amoxicillin-clavulanate potassium 3 times daily and oral ciprofloxacin twice daily on admission to the hospital. Treatment continues for 7 days in the absence of clinical deterioration or unacceptable toxicity. Patients are assessed as inpatients after ≥ 24 and up to 72 hours after the first antibiotic dose. Patients showing clear response (i.e., symptomatic improvement irrespective of neutrophil recovery, temperature ≤ 37.8 C for 24 hours) and who continue to meet study eligibility criteria are randomized to 1 of 2 arms.

• Arm I (early discharge): Patients are discharged home and instructed to remain in daily contact with hospital staff to report temperature and symptoms until completion of oral antibiotic regimen.
• Arm II (standard management): Patients continue their antibiotic course in hospital and are discharged according to local guidelines and the following additional criteria: subjective improvement, afebrile (≤ 37°C for 24 hours), and absolute neutrophil count ≥ 500/mm³ and rising.

Patients in both arms complete a daily diary documenting daily temperature readings, symptoms, and toxicities. Patients also complete a Health Questionnaire and a Cancer Worries Inventory Booklet at baseline, in the hospital immediately after randomization, and at completion of oral antibiotics or resolution of neutropenic febrile episode.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 400 patients will be accrued for this study.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	400 participants
Allocation:	Randomized
Primary Purpose:	Supportive Care
Official Title:	A Prospective Randomised Phase III Trial of Early Hospital Discharge Versus Standard Inpatient Management of Cancer Patients With Low-Risk Febrile Neutropenia Receiving Oral Antibiotics. Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discharge [ORANGE]
Study Start Date :	July 2007
Estimated Primary Completion Date :	July 2010

Arms and Interventions

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Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Total number of days of hospitalization (including unplanned readmission) (randomized patients)
2. Incidence of serious adverse events (randomized and registered patients)

Secondary Outcome Measures :

1. Incidence of treatment failure as defined by the necessity for change in antibiotic therapy (randomized and registered patients)
2. Incidence of unplanned readmissions (randomized patients)
3. Patient acceptability of randomized discharge policy as measured by Health Questionnaire, Cancer Worries Inventory Booklet, and Patient Daily Diary (randomized patients)
4. Toxicity attributed to oral antibiotic therapy as measured by NCI CTCAE v3.0 (randomized and registered patients)
5. Health service costs (randomized patients)

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of solid tumor or lymphoma AND meets the following criteria:

  • Low-risk patient, defined as Multinational Association for Supportive Care in Cancer prognostic index score ≥ 21

  • Presents with neutropenic fever defined as follows:

    • Absolute neutrophil count ≤ 500/mm³ OR < 1,000/mm³ but anticipated to fall to ≤ 500/mm³ within 24 hours of study entry
    • Temperature ≥ 38.5°C on a single measurement or ≥ 38.0°C on > 1 occasion (one of which could be measured by the patient prior to admission) ≥ 1 hour apart
  • Undergoing concurrent cytotoxic chemotherapy for treatment of solid tumors or lymphoma
• No leukemia

PATIENT CHARACTERISTICS:

• Compliant and appropriate for early discharge
• Able to read a thermometer (patient or caregiver)
• Able to tolerate oral medication
• Must have a responsible adult caregiver if eligible for early discharge
• No known allergy to oral antibiotics or penicillin
• No requirement for IV fluid support
• No central venous catheter-associated infection or evidence of infection not amenable to treatment by study antibiotics
• No neutropenic fever at high risk of complications
• No associated comorbidity that requires hospitalization and management
• No known HIV positivity

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior participation in this study for neutropenic episode
• No prior bone marrow transplantation or peripheral blood stem cell transplantation
• No prior treatment for leukemia

• More than 72 hours since prior antibiotics, including prophylactic antibiotics

  • Prophylactic septrin (for pneumocystis), acyclovir, or antifungals are allowed
• No concurrent granulocyte colony-stimulating factor therapy

Contacts and Locations

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Locations

United Kingdom
Gloucestershire Oncology Centre at Cheltenham General Hospital	Recruiting
Cheltenham, England, United Kingdom, GL53 7AN
Contact: Contact Person 44-0124-2222-2222
Princess Royal Hospital at Hull and East Yorkshire NHS Trust	Recruiting
Hull, England, United Kingdom, HU8 9HE
Contact: Contact Person 44-0148-2701151
Leicester Royal Infirmary	Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: Contact Person 44-011-6254-1414
Clatterbridge Centre for Oncology	Recruiting
Merseyside, England, United Kingdom, CH63 4JY
Contact: Ernest Marshall, MD 44-151-334-1155
Northampton General Hospital	Recruiting
Northampton, England, United Kingdom, NN1 5BD
Contact: Contact Person 44-016-0463-4700
Peterborough Hospitals Trust	Recruiting
Peterborough, England, United Kingdom, PE3 6DA
Contact: Contact Person 44-0173-387-4000
Cancer Research Centre at Weston Park Hospital	Recruiting
Sheffield, England, United Kingdom, S1O 2SJ
Contact: Contact Person 44-114-226-5000
Airedale General Hospital	Recruiting
West Yorkshire, England, United Kingdom, BD20 6TD
Contact: Contact Person 44-015-356-2511
Western Infirmary	Recruiting
Glasgow, Scotland, United Kingdom, G11 6NT
Contact: Contact Person 44-0114-226-5000
Ysbyty Gwynedd	Recruiting
Bangor, Wales, United Kingdom, LL57 2PW
Contact: Contact Person 44-0124-838-4384

Sponsors and Collaborators

Clatterbridge Centre for Oncology

Investigators

Study Chair:	Ernest Marshall, MD	Clatterbridge Centre for Oncology

More Information

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ClinicalTrials.gov Identifier:	NCT00445497 History of Changes
Other Study ID Numbers:	CRUK-MX3006; CDR0000533828 ( Registry Identifier: PDQ (Physician Data Query) ); CRUK-ORANGE; ISRCTN18467252; EU-20707
First Posted:	March 9, 2007
Last Update Posted:	August 12, 2013
Last Verified:	May 2007

Keywords provided by National Cancer Institute (NCI):

psychosocial effects of cancer and its treatment; anaplastic large cell lymphoma; angioimmunoblastic T-cell lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; intraocular lymphoma; nodal marginal zone B-cell lymphoma; primary central nervous system non-Hodgkin lymphoma; primary central nervous system Hodgkin lymphoma; recurrent adult Burkitt lymphoma; recurrent adult diffuse large cell lymphoma; recurrent adult diffuse mixed cell lymphoma; recurrent adult diffuse small cleaved cell lymphoma; recurrent adult Hodgkin lymphoma; recurrent adult immunoblastic large cell lymphoma; recurrent adult lymphoblastic lymphoma

recurrent cutaneous T-cell non-Hodgkin lymphoma; recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma; recurrent grade 3 follicular lymphoma; recurrent mantle cell lymphoma; recurrent marginal zone lymphoma; recurrent mycosis fungoides/Sezary syndrome; recurrent small lymphocytic lymphoma; small intestine lymphoma; splenic marginal zone lymphoma; stage III adult Burkitt lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult Hodgkin lymphoma

Additional relevant MeSH terms:

Lymphoma; Neoplasms; Neutropenia; Nervous System Neoplasms; Central Nervous System Neoplasms; Febrile Neutropenia; Intestinal Neoplasms; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders	Hematologic Diseases; Neoplasms by Site; Nervous System Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anti-Bacterial Agents; Amoxicillin; Ciprofloxacin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination; Antibiotics, Antitubercular