Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase III	Supportive care	Closed	16 and over	Other	CRC-TU-SIGNIFICANT EU-99054, NCT00005590

Objectives

1. Determine whether prophylactic treatment with levofloxacin reduces the rate of clinical infection in patients receiving myelosuppressive antineoplastic chemotherapy for solid tumors or lymphoma.

Entry 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

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

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

Expected Enrollment

A total of 1,500 patients (750 per arm) will be accrued for this study within 3 years.

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.

Cullen M, Steven N, Billingham L, et al.: Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas. N Engl J Med 353 (10): 988-98, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

Cancer Research UK Clinical Trials Unit - Birmingham

Steven Neil, MB, MA, BS, PhD, DTMH, MRCP, Protocol chair		Ph: 44-121-414-2803 Email: n.m.steven@bham.ac.uk

Registry Information
Official Title		A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors
Trial Start Date		1999-08-03
Registered in ClinicalTrials.gov		NCT00005590
Date Submitted to PDQ		2000-02-11
Information Last Verified		2002-07-31

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