Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005590
First received: May 2, 2000
Last updated: August 1, 2013
Last verified: July 2002
History of Changes
  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 3

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:

MedlinePlus related topics: Cancer Lymphoma
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):
Study Start Date: August 1999
Study Completion Date: September 2005
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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:

ClinicalTrials.gov Identifier: NCT00005590     History of Changes
Other Study ID Numbers: CRC-TU-SIGNIFICANT  CDR0000067666  EU-99054 
Study First Received: May 2, 2000
Last Updated: August 1, 2013
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:
Infection
Communicable Diseases
Lung Neoplasms
Lymphoma
Breast Neoplasms
Neoplasms
Neoplasms, Germ Cell and Embryonal
Nervous System Neoplasms
Central Nervous System Neoplasms
Testicular Neoplasms
Intestinal Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
 Respiratory Tract Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Breast Diseases
Skin Diseases
Nervous System Diseases
Endocrine Gland Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Genital Diseases, Male
Endocrine System Diseases
Testicular Diseases

ClinicalTrials.gov processed this record on September 23, 2016