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A Phase II Study to Evaluate the Efficacy of Bevacizumab Plus Irinotecan in Recurrent Anaplastic Astrocytoma or Recurrent Glioblastoma Multiforme


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Glioblastoma, Astrocytoma

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Trial Information

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Progression-free survival

Outcome Time Frame:

6 months, 1 year

Safety Issue:

No

Authority:

South Korea: Institutional Review Board

Study ID:

CRCST-L-0006

NCT ID:

NCT00921167

Start Date:

June 2009

Completion Date:

December 2013

Related Keywords:

  • Glioblastoma
  • Astrocytoma
  • Glioblastoma
  • Astrocytoma
  • Chemotherapy
  • Astrocytoma
  • Glioblastoma

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