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Randomized Study of Meropenem vs Ceftazidime/Amikacin as Empirical Therapy for Fever in Cancer Patients with Granulocytopenia (Summary Last Modified 09/93)
Basic Trial Information
Objectives I. Compare the efficacy and safety of meropenem vs. ceftazidime/amikacin in patients with cancer who are febrile and granulocytopenic. Entry Criteria Disease Characteristics: See General Eligibility Criteria Prior/Concurrent Therapy: More than 30 days since treatment with any investigational drug (other than colony stimulating factors) Prior treatment on protocol allowed during previous episodes of neutropenia Patient Characteristics: Age: At least 3 months Performance status: Not specified Life expectancy: At least 48 hours Not moribund or comatose from any cause with little hope of recovery No danger of hepatic stupor or coma Hematopoietic: AGC no greater than 1,000 and expected to fall below 500 within 24-48 hours Hepatic: No danger of hepatic stupor or coma Renal: Creatinine no greater than 3.4 mg/dl (no greater than ULN for age in children) Creatinine clearance (estimated) at least 25 ml/min No renal failure requiring hemodialysis or peritoneal dialysis Other: No known allergy to meropenem, ceftazidime, or amikacin No history of immediate or accelerated allergic reaction to penicillin, cephalosporin, or carbapenem antibiotics No known HIV infection No pregnant or nursing women General Eligibility Criteria: --Population Characteristics-- Patients with cancer and granulocytopenic fever, defined as: AGC no greater than 1,000 and anticipated to fall below 500 within 24-48 hours Febrile, i.e., oral or axillary temperature at least 38.5 C (101.3 F) or at least 38 C (100.4 F), respectively, on 2 or more occasions during a 12-hour period Presumed infection Patients with active leukemia, Hodgkin's disease, non-Hodgkin's lymphoma, or solid tumor or who have undergone allogeneic or autologous bone marrow transplant for any neoplastic disease eligible No intravenous antibiotic therapy for at least 4 days (96 hours) Patients must be willing to discontinue all prophylactic antibiotics (cotrimoxazole, quinolones, or macrolides) when protocol therapy is initiated Patients may only enter protocol once per episode of neutropenia --Prior/Concurrent Therapy-- More than 30 days since treatment with any investigational drug (other than colony stimulating factors) Prior treatment on protocol allowed during previous episodes of neutropenia --Patient Characteristics-- Age: At least 3 months Performance status: Not specified Life expectancy: At least 48 hours Not moribund or comatose from any cause with little hope of recovery No danger of hepatic stupor or coma Hematopoietic: AGC no greater than 1,000 and expected to fall below 500 within 24-48 hours Hepatic: No danger of hepatic stupor or coma Renal: Creatinine no greater than 3.4 mg/dl (no greater than ULN for age in children) Creatinine clearance (estimated) at least 25 ml/min No renal failure requiring hemodialysis or peritoneal dialysis Other: No known allergy to meropenem, ceftazidime, or amikacin No history of immediate or accelerated allergic reaction to penicillin, cephalosporin, or carbapenem antibiotics No known HIV infection No pregnant or nursing women Expected Enrollment A total of 826 evaluable patients (413 per arm) will be studied. If a significant number of adverse events is seen in patients treated on Arm I or if unacceptably low efficacy is observed on either arm, the trial may be stopped after accrual of 200 and 500 patients. Outline Randomized study. Arm I: Antibiotic Therapy. Meropenem. Arm II: Antibiotic Therapy. Ceftazidime; Amikacin. Trial Lead Organizations European Organization for Research and Treatment of Cancer
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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