Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma - Full Text View

Purpose

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	Intervention	Phase
Brain and Central Nervous System Tumors Breast Cancer Extragonadal Germ Cell Tumor Infection Lung Cancer Lymphoma Ovarian Cancer Small Intestine Cancer Testicular Germ Cell Tumor Unspecified Adult Solid Tumor, Protocol Specific	Drug: levofloxacin	Phase III

Genetics Home Reference related topics:

Benign Tumors Cancer breast cancer

MedlinePlus related topics:

Breast Cancer Cancer Fungal Infections Hodgkin's Disease Intestinal Cancer Leukemia, Adult Acute Leukemia, Adult Chronic Leukemia, Childhood Lung Cancer Lymphoma Ovarian Cancer

ChemIDplus related topics:

Levofloxacin Ofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

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

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

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

August 1999

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.

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.

Eligibility

Ages Eligible for Study:	16 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005590

Locations


United Kingdom, England
	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

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications of Results:

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 Number of Tumours (SIGNIFICANT) Trial Group. Antibacterial prophylaxis after chemotherapy for solid tumors and lymphomas. N Engl J Med. 2005 Sep 8;353(10):988-98.

Study ID Numbers:	CDR0000067666, CRC-TU-SIGNIFICANT, EU-99054
First Received:	May 2, 2000
Last Updated:	May 23, 2008
ClinicalTrials.gov Identifier:	NCT00005590
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I adult Hodgkin lymphoma

stage II adult Hodgkin lymphoma

stage III adult Hodgkin lymphoma

stage IV adult Hodgkin lymphoma

recurrent breast cancer

recurrent adult Hodgkin lymphoma

stage I cutaneous T-cell non-Hodgkin lymphoma

stage II cutaneous T-cell non-Hodgkin lymphoma

stage III cutaneous T-cell non-Hodgkin lymphoma

stage IV cutaneous T-cell non-Hodgkin lymphoma

recurrent cutaneous T-cell non-Hodgkin lymphoma

limited stage small cell lung cancer

extensive stage small cell lung cancer

recurrent small cell lung cancer

small intestine lymphoma

stage II malignant testicular germ cell tumor

stage III malignant testicular germ cell tumor

unspecified adult solid tumor, protocol specific

stage I grade 2 follicular lymphoma

stage I grade 3 follicular lymphoma

Study placed in the following topic categories:

Thoracic Neoplasms

Sezary syndrome

Hodgkin lymphoma, adult

Lymphoma, Mantle-Cell

Lymphoma, small cleaved-cell, diffuse

Urogenital Neoplasms

Central Nervous System Neoplasms

Lymphoma, large-cell, immunoblastic

Central nervous system lymphoma, primary

Duodenal Neoplasms

Lung Neoplasms

Lymphoma, Large-Cell, Anaplastic

Hodgkin Disease

Nervous System Neoplasms

Breast Diseases

Endocrine Gland Neoplasms

Lymphoma, Large B-Cell, Diffuse

Immunoproliferative Disorders

Digestive System Neoplasms

Leukemia, B-cell, chronic

Additional relevant MeSH terms:

Communicable Diseases

Anti-Infective Agents

Molecular Mechanisms of Pharmacological Action

Renal Agents

Infection

Ileal Diseases

Genital Diseases, Female

Anti-Bacterial Agents

Neoplasms by Site

Respiratory Tract Diseases

Jejunal Diseases

Therapeutic Uses

Nucleic Acid Synthesis Inhibitors

Respiratory Tract Neoplasms

Neoplasms by Histologic Type

Immune System Diseases

Skin Diseases

Nervous System Diseases

Endocrine System Diseases

Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 03, 2008

Sponsored by:	Cancer Research Campaign Clinical Trials Centre
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00005590