A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors
Phase 3
16 Years
N/A
16 Years
N/A
Open (Enrolling)
Both
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
Both
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
Trial Information
A Randomized, Prospective Double-Blind, Placebo-Controlled Trial of Prophylactic Oral Levofloxacin Following Chemotherapy for Lymphoma and Solid Tumors
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care
Principal Investigator
Steven M. Neil, MB, MA, BS, PhD, DTMH, MRCP
Investigator Role:
Study Chair
Investigator Affiliation:
University Hospital Birmingham
Authority:
United States: Federal Government
Study ID:
CDR0000067666
NCT ID:
NCT00005590
Start Date:
August 1999
Completion Date:
Related Keywords:
- 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
- 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
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent adult Burkitt lymphoma
- stage I adult T-cell leukemia/lymphoma
- stage II adult T-cell leukemia/lymphoma
- stage III adult T-cell leukemia/lymphoma
- stage IV adult T-cell leukemia/lymphoma
- recurrent adult T-cell leukemia/lymphoma
- extragonadal germ cell tumor
- adult central nervous system germ cell tumor
- primary central nervous system non-Hodgkin lymphoma
- infection
- intraocular lymphoma
- stage I mantle cell lymphoma
- contiguous stage II grade 1 follicular lymphoma
- contiguous stage II grade 2 follicular lymphoma
- contiguous stage II grade 3 follicular lymphoma
- contiguous stage II adult diffuse small cleaved cell lymphoma
- contiguous stage II mantle cell lymphoma
- contiguous stage II adult diffuse mixed cell lymphoma
- contiguous stage II adult immunoblastic large cell lymphoma
- contiguous stage II adult diffuse large cell lymphoma
- contiguous stage II adult Burkitt lymphoma
- contiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- recurrent mantle cell lymphoma
- angioimmunoblastic T-cell lymphoma
- anaplastic large cell lymphoma
- stage I mycosis fungoides/Sezary syndrome
- stage II mycosis fungoides/Sezary syndrome
- stage III mycosis fungoides/Sezary syndrome
- stage IV mycosis fungoides/Sezary syndrome
- recurrent mycosis fungoides/Sezary syndrome
- contiguous stage II marginal zone lymphoma
- contiguous stage II small lymphocytic lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage I marginal zone lymphoma
- stage I small lymphocytic lymphoma
- stage II small lymphocytic lymphoma
- stage II marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- 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
Name | Location |
|---|
