Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
NCT ID: NCT00005590
Last Updated: 2013-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
INTERVENTIONAL
1999-08-31
2005-09-30
Brief Summary
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PURPOSE: Randomized phase III trial to determine the effectiveness of levofloxacin in preventing infection in patients receiving chemotherapy for solid tumors or lymphoma.
Detailed Description
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* Determine whether prophylactic treatment with levofloxacin reduces the rate of clinical infection in patients receiving myelosuppressive antineoplastic chemotherapy for solid tumors or lymphoma.
OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to age (under 40 vs 40-59 vs 60 and over), type of cancer (non-Hodgkin's lymphoma vs Hodgkin's lymphoma vs breast vs germ cell vs small cell lung cancer vs other), and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oral levofloxacin once daily for 7 consecutive days during the expected neutrophil nadir of each chemotherapy course.
* Arm II: Patients receive an oral placebo once daily for 7 consecutive days as in arm I.
Treatment in both arms continues for up to 6 courses in the absence of unacceptable side effects or allergy or a clear continuing indication for the prophylactic use of antibacterial agents during subsequent courses.
PROJECTED ACCRUAL: A total of 1,500 patients (750 per arm) will be accrued for this study within 3 years.
Conditions
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Keywords
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Study Design
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RANDOMIZED
SUPPORTIVE_CARE
DOUBLE
Interventions
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levofloxacin
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of solid tumor, including but not limited to, the following:
* Stage II-IV germ cell malignancy
* Small cell lung cancer
* Recurrent breast cancer OR
* Diagnosis of lymphoma
* About to start a program of antineoplastic chemotherapy for malignant disease that will regularly induce myelosuppression with a risk of temporary severe neutropenia (i.e., neutrophil count less than 500/mm3), but does not routinely require filgrastim (G-CSF) or stem cell support
* Not previously randomized into the Significant trial for a different multicourse chemotherapy program
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age:
* 16 and over
Sex:
* Not specified
Menopausal status:
* Not specified
Performance status:
* Not specified
Life expectancy:
* Not specified
Hematopoietic:
* See Disease Characteristics
Hepatic:
* Not specified
Renal:
* Creatinine normal OR
* Creatinine clearance greater than 40 mL/min
Other:
* Not pregnant or nursing
* Fertile patients must use effective contraception in addition to oral contraceptive pills
* HIV negative
* No epilepsy
* No history of adverse events resulting from fluoroquinolone therapy (e.g., allergy or tendinitis)
* No concurrent use of a sunbed or exposure to strong sunlight
PRIOR CONCURRENT THERAPY:
Biologic therapy:
* See Disease Characteristics
Chemotherapy:
* See Disease Characteristics
Endocrine therapy:
* Not specified
Radiotherapy:
* Not specified
Surgery:
* Not specified
Other:
* No other concurrent antibacterial therapy
* No other concurrent prophylactic antibacterial agents including cotrimoxazole prophylaxis against Pneumocystis carinii
* No iron supplements, sucralfate, or mineral antacids 2 hours before or after study medication
* Concurrent entry into other clinical trials allowed
16 Years
ALL
No
Sponsors
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Cancer Research Campaign Clinical Trials Centre
OTHER
Principal Investigators
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Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP
Role: STUDY_CHAIR
University Hospital Birmingham
Locations
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University of Birmingham
Birmingham, England, United Kingdom
Countries
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References
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Cullen M, Steven N, Billingham L, Gaunt C, Hastings M, Simmonds P, Stuart N, Rea D, Bower M, Fernando I, Huddart R, Gollins S, Stanley A; Simple Investigation in Neutropenic Individuals of the Frequency of Infection after Chemotherapy +/- Antibiotic in a Number of Tumours (SIGNIFICANT) Trial Group. Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas. N Engl J Med. 2005 Sep 8;353(10):988-98. doi: 10.1056/NEJMoa050078.
Other Identifiers
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CDR0000067666
Identifier Type: REGISTRY
Identifier Source: secondary_id
EU-99054
Identifier Type: -
Identifier Source: secondary_id
CRC-TU-SIGNIFICANT
Identifier Type: -
Identifier Source: org_study_id