A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme
Inclusion Criteria:
- Histologically diagnosed recurrent anaplastic astrocytoma or recurrent glioblastoma
multiforme
- At least 18 years of age
- Performance status of 0 and 1 on the Eastern Cooperative Oncology Group (ECOG)
criteria
- One or more measurable disease
- Adequate hematologic (neutrophil count >= 1500/uL, platelets >= 100,000/uL), hepatic
(transaminase =< upper normal limit (UNL)x2.5, bilirubin level =< UNLx1.5, alkaline
phosphatase =< UNLx2.5), and renal (creatinine clearance >= 30mL/min)
- Expected life time more than at least 2 months
- A patients who signed the informed consent prior to the participation in the study
Exclusion Criteria:
- A pregnant or lactating patient
- A patient of childbearing potential without being tested for pregnancy at baseline or
with a positive test. (A premenopausal woman with the amenorrhea period of at least
12 months or longer is considered to have non-childbearing potential.)
- A man or woman of childbearing potential without the willingness to use a
contraceptive measures during the study
- A patient with history of another malignant disease within past 3 years, except
curatively treated basal cell carcinoma of the skin, cervical carcinoma in situ, and
early gastric cancer
- Medically uncontrolled serious heart, lung, neurological, psychological, or metabolic
disease
- Uncontrolled serious infection
- Enrollment in other study within 30 days
- Hemorrhage on baseline radiologic examination
- A patient who refused to sign the informed consent