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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00005590
• Other study ID #: CRC-TU-SIGNIFICANT
• Secondary ID: CDR0000067666EU-
• Status: Completed
• Phase: Phase 3
• First received: May 2, 2000
• Last updated: August 1, 2013
• Start date: August 1999
• Est. completion date: September 2005

Study information

• Verified date: July 2002
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

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

Intervention

Drug:
• levofloxacin

Locations

Country	Name	City	State
United Kingdom	University of Birmingham	Birmingham	England

Sponsors (1)

Lead Sponsor	Collaborator
Cancer Research Campaign Clinical Trials Centre

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

Cullen M, Steven N, Billingham L, Gaunt C, Hastings M, Simmonds P, Stuart N, Rea D, Bower M, Fernando I, Huddart R, Gollins S, Stanley A; Simple Investigation in Neutropenic Individuals of the Frequency of Infection after Chemotherapy +/- Antibiotic in a — View Citation