Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Supportive care	Closed	at least 3 months		EORTC-46931

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 Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Michel P. Glauser, MD, Protocol chair		Ph: 41-21-314-1010