Levofloxacin to Prevent Infection Following Chemotherapy in Treating

Status Completed

Clinical Trial 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 Trial 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. ;

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

Brain and Central Nervous System Tumors
Breast Cancer
Central Nervous System Neoplasms
Extragonadal Germ Cell Tumor
Infection
Lung Cancer
Lymphoma
Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Ovarian Cancer
Small Intestine Cancer
Testicular Germ Cell Tumor
Testicular Neoplasms
Unspecified Adult Solid Tumor, Protocol Specific

Clinical Trial Details

NCT number	NCT00005590
Study type	Interventional
Source	National Cancer Institute (NCI)
Contact
Status	Completed
Phase	Phase 3
Start date	August 1999
Completion date	September 2005

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms