Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Brain and Central Nervous System Tumors; Breast Cancer; Extragonadal Germ Cell Tumor; Infection; Lung Cancer; Lymphoma; Ovarian Cancer; Small Intestine Cancer; Testicular Germ Cell Tumor; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: levofloxacin (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Cancer Research Campaign Clinical Trials Centre Official(s) and/or principal investigator(s):
Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP, Study Chair, Affiliation: University Hospital Birmingham
Summary
RATIONALE: Giving antibiotics may be effective in preventing or controlling early infection
in patients receiving chemotherapy for solid tumors or lymphoma. It is not yet known if
levofloxacin if effective in preventing infection.
PURPOSE: Randomized phase III trial to determine the effectiveness of levofloxacin in
preventing infection in patients receiving chemotherapy for solid tumors or lymphoma.
Clinical Details
Official title: A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors
Study design: Supportive Care, Randomized, Double-Blind, Active Control
Detailed description:
OBJECTIVES:
- 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.
Eligibility
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
DISEASE CHARACTERISTICS:
- 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
Locations and Contacts
University of Birmingham, Birmingham, England B15 2TT, United Kingdom
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: August 1999
Last updated: May 23, 2008
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