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Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma Clinical research trials and Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma. Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma clinical trial. Test subjects typically receive the most effective healthcare possible for their Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "L" Clinical Trials Conditions > Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma  Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
For Condition: Infection,Cancer
Status: No longer recruiting
Sponsor(s): Cancer Research Campaign Clinical Trials Centre ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
StevenNeil, Study Chair, University of Birmingham
University of Birmingham
Birmingham, England, B15 2TT
United Kingdom
Additional Information:
Study ID Numbers: CDR0000067666; CRC-TU-SIGNIFICANT,EU-99054
Study Start Date:
Record last reviewed: November 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005590
Other Cancer Studies:
1. Voriconazole With or Without Interferon gamma in Treating Patients With Aspergillosis or Other Fungal Infections
2. Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
3. A Safety Evaluation of Xigris in Patients with Blood Cancer who Develop Severe Infection related to Bone Marrow Transplantation.
4. Antibiotic Therapy in Preventing Early Infection in Patients With Multiple Myeloma Who Are Receiving Chemotherapy
5. Fluconazole Compared With Voriconazole in Preventing Invasive Fungal Infections in Patients Undergoing Allogeneic Hematopoietic Transplantation
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Levofloxacin to Prevent Infection Following Chemotherapy in Treating Patients With Solid Tumors or Lymphoma
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