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Sponsored by: |
Cancer Research Campaign Clinical Trials Centre |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00005590 |
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 Cancer-Related Problem/Condition Extragonadal Germ Cell Tumor 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: | 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 |
Study Start Date: | August 1999 |
OBJECTIVES:
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.
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.
Ages Eligible for Study: | 16 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Diagnosis of solid tumor, including but not limited to, the following:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United Kingdom, England | |
University of Birmingham | |
Birmingham, England, United Kingdom, B15 2TT |
Study Chair: | Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP | University Hospital Birmingham |
Study ID Numbers: | CDR0000067666, CRC-TU-SIGNIFICANT, EU-99054 |
Study First Received: | May 2, 2000 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00005590 History of Changes |
Health Authority: | United States: Federal Government |
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 |
Thoracic Neoplasms Lymphoma, Mantle-Cell Mantle Cell Lymphoma Urogenital Neoplasms Central Nervous System Neoplasms Follicular Lymphoma Ileal Diseases Duodenal Neoplasms Mycoses Leukemia, Lymphocytic, Chronic, B-Cell Lung Neoplasms Lymphoma, Large-Cell, Anaplastic Ovarian Cancer Hodgkin Disease Nervous System Neoplasms |
Breast Diseases Endocrine Gland Neoplasms Lymphoma, Large B-Cell, Diffuse Digestive System Neoplasms Immunoproliferative Disorders Testicular Cancer Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Anti-Infective Agents, Urinary Testicular Neoplasms Carcinoma, Small Cell B-cell Lymphomas Lung Diseases Leukemia, T-Cell |
Thoracic Neoplasms Anti-Infective Agents Molecular Mechanisms of Pharmacological Action Urogenital Neoplasms Central Nervous System Neoplasms Renal Agents Ileal Diseases Duodenal Neoplasms Neoplasms by Site Lung Neoplasms Therapeutic Uses Breast Diseases Nervous System Neoplasms Nucleic Acid Synthesis Inhibitors Endocrine Gland Neoplasms |
Immunoproliferative Disorders Digestive System Neoplasms Immune System Diseases Nervous System Diseases Genital Neoplasms, Female Breast Neoplasms Endocrine System Diseases Anti-Infective Agents, Urinary Neoplasms Lung Diseases Gastrointestinal Neoplasms Lymphoma, Non-Hodgkin Gonadal Disorders Gastrointestinal Diseases Ofloxacin |