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

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Masking: Double-Blind Primary Purpose: Supportive Care
Official Title:	A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Fungal Infections Hodgkin Disease Intestinal Cancer Leukemia Lung Cancer Lymphoma Ovarian Cancer

Drug Information available for: Ofloxacin Levofloxacin Ofloxacin hydrochloride

U.S. FDA Resources

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
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

Additional Information:

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

Publications:

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.

ClinicalTrials.gov Identifier:	NCT00005590 History of Changes
Other Study ID Numbers:	CDR0000067666, CRC-TU-SIGNIFICANT, EU-99054
Study First Received:	May 2, 2000
Last Updated:	March 13, 2010
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
stage I adult diffuse small cleaved cell lymphoma
stage I adult diffuse mixed cell lymphoma
stage I adult diffuse large cell lymphoma
stage I adult immunoblastic large cell lymphoma
stage I adult lymphoblastic lymphoma
stage I adult Burkitt lymphoma
stage II ovarian germ cell tumor
stage III ovarian germ cell tumor
stage IV ovarian germ cell tumor
stage III grade 1 follicular lymphoma

Additional relevant MeSH terms:

Breast Neoplasms
Lung Neoplasms
Lymphoma
Lymphoma, Non-Hodgkin
Nervous System Neoplasms
Ovarian Neoplasms
Lymphoma, Large-Cell, Immunoblastic
Central Nervous System Neoplasms
Duodenal Neoplasms
Ileal Neoplasms
Jejunal Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms
Intestinal Neoplasms
Neoplasms by Site

Breast Diseases
Skin Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Nervous System Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on February 12, 2012