Official Title: “A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors”

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.

Study Type: Interventional

Study Design: Supportive Care, Randomized, Double-Blind, Active Control

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.

Intervention(s) in this Clinical Trial

• Drug: levofloxacin

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 16 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Cancer Research Campaign Clinical Trials Centre

Overall Clinical Trial Officials and Contacts

Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP Study Chair University Hospital Birmingham  

Information obtained from ClinicalTrials.gov on September 04, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00005590

Study ID Number: CDR0000067666

ClinicalTrials.gov Identifier: NCT00005590

Health Authority: United States: Federal Government

Clinical trial summary from the National Cancer Institute's PDQ® database