Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
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.
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Arm I: Patients receive oral levofloxacin once daily for 7 consecutive days during the expected neutrophil nadir of each chemotherapy course.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Diagnosis of solid tumor, including but not limited to, the following:
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Stage II-IV germ cell malignancy
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Small cell lung cancer
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Recurrent breast cancer OR
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Diagnosis of lymphoma
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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
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Not previously randomized into the Significant trial for a different multicourse chemotherapy program
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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
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Creatinine clearance greater than 40 mL/min
Other:
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Not pregnant or nursing
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Fertile patients must use effective contraception in addition to oral contraceptive pills
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HIV negative
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No epilepsy
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No history of adverse events resulting from fluoroquinolone therapy (e.g., allergy or tendinitis)
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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:
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No other concurrent antibacterial therapy
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No other concurrent prophylactic antibacterial agents including cotrimoxazole prophylaxis against Pneumocystis carinii
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No iron supplements, sucralfate, or mineral antacids 2 hours before or after study medication
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Concurrent entry into other clinical trials allowed
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Birmingham | Birmingham | England | United Kingdom | B15 2TT |
Sponsors and Collaborators
- Cancer Research Campaign Clinical Trials Centre
Investigators
- Study Chair: Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP, University Hospital Birmingham
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRC-TU-SIGNIFICANT
- CDR0000067666
- EU-99054