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Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
This study has been completed.
Sponsor:
Cancer Research Campaign Clinical Trials Centre
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
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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:
Genetics Home Reference related topics:
lung cancer
MedlinePlus related topics:
Lymphoma
Genetic and Rare Diseases Information Center resources:
Lymphosarcoma
Ovarian Cancer
Chronic Lymphocytic Leukemia
Leukemia, B-cell, Chronic
B-cell Lymphoma
Hodgkin Lymphoma
Cutaneous T-cell Lymphoma
Follicular Lymphoma
Mantle Cell Lymphoma
Small Intestine Cancer
Diffuse Large B-Cell Lymphoma
Lymphoma, Large-cell
Lymphoblastic Lymphoma
Burkitt Lymphoma
Marginal Zone Lymphoma
Leukemia, T-cell, Chronic
Adult T-cell Leukemia/lymphoma
Testicular Cancer
Anaplastic Large Cell Lymphoma
Angioimmunoblastic T-cell Lymphoma
Angioimmunoblastic Lymphadenopathy With Dysproteinemia
Mycosis Fungoides
Sezary Syndrome
Plasmablastic Lymphoma
Lymphoma, Large-cell, Immunoblastic
Ovarian Germ Cell Tumor
Extragonadal Germ Cell Tumor
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
| Study Start Date: | August 1999 |
| Study Completion Date: | September 2005 |
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) |
| Sexes Eligible for Study: | All |
| 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
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 ( Registry Identifier: PDQ (Physician Data Query) ) EU-99054 |
| Study First Received: | May 2, 2000 |
| Last Updated: | August 1, 2013 |
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:
|
Lymphoma Neoplasms Infection Communicable Diseases Lung Neoplasms Neoplasms, Germ Cell and Embryonal Nervous System Neoplasms Central Nervous System Neoplasms Testicular Neoplasms Intestinal Neoplasms Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |
Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Nervous System Diseases Endocrine Gland Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Endocrine System Diseases Testicular Diseases Gonadal Disorders Gastrointestinal Neoplasms Digestive System Neoplasms |
ClinicalTrials.gov processed this record on June 23, 2017