A Single Arm Phase II Study of Bevacizumab and Extended Treatment of Temozolomide in Patients With Recurrent Glioblastoma Multiforme
Overview
- Phase
- Phase 2
- Intervention
- bevacizumab [Avastin]
- Conditions
- Glioblastoma Multiforme
- Sponsor
- Hoffmann-La Roche
- Enrollment
- 32
- Primary Endpoint
- PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
This is a Phase II, national, multicenter, open-label, non-comparative study to investigate the efficacy and safety of bevacizumab and temozolomide in patients with recurrent glioblastoma multiforme (GBM) after a first treatment failure. Patients will receive bevacizumab 10 mg/kg intravenously every two weeks until disease progression, consent withdrawal, or unacceptable toxicity. Anticipated time on study treatment is 12-24 months.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age \>= 18 years
- •Histological diagnosis of glioblastoma multiforme (GBM) documented by surgical resection or biopsy.
- •They should be patients in a first relapse treated with radiotherapy and chemotherapy and chemotherapy based on temozolomide 150-200 mg/m2 on days 1 to 5 every 28 days (Stupp regimen) for at least three cycles. At least 4 weeks must have lapsed since previous chemotherapy and 3 months since the last dose of radiotherapy.
- •Use of an effective contraceptive method by patients and their partners.
- •Stable or decreasing corticosteroid dose for the five days prior to study entry
- •Adequate hematological function
- •Adequate liver function
- •Adequate kidney function
Exclusion Criteria
- •Signs of recent bleeding at the MRI of the brain. However, patients with clinically asymptomatic presence of hemosiderin, resolving bleeding changes related to surgery, and presence of punctate hemorrhage in the tumor will be allowed to participate in the study.
- •Prior treatment with bevacizumab
- •Poorly controlled arterial hypertension
- •History of hypertensive crises or hypertensive encephalopathy
- •New York Health Association (NYHA) Class II or higher congestive heart failure
- •History of myocardial infarction or unstable angina pectoris within six months of study entry
- •History of stroke or TIA within six months of study entry
- •Significant vascular disease within six months of study entry
- •History of hemoptysis \> grade 2 according to the NCI CTC criteria within one month of study entry
- •Evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation)
Arms & Interventions
A
Intervention: bevacizumab [Avastin]
A
Intervention: temozolomide
Outcomes
Primary Outcomes
PFS: Probability of Remaining Progression Free at 24 Weeks After Beginning the Study
Time Frame: BL, 24 weeks (after 6th cycle)
Progression-Free Survival (PFS) - Percentage of Participants With an Event
Time Frame: Baseline (BL), every 28 days, until progression, death or end-of-study, an average of 32 weeks
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment.
PFS - Time to Event
Time Frame: BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks
PFS was defined as the time, in weeks, from the date of inclusion in the study to the date of the first documentation of disease progression or death of the participant due to any cause. Participants that did not have an event at the time the analysis was performed were censored at the date of last contact. Participants that began a treatment other than those planned in this study (bevacizumab or temozolomide) were censored on the start date of the new treatment. PFS was estimated using the Kaplan-Meier method.
Secondary Outcomes
- Overall Survival - Percentage of Participants With an Event(BL, every 28 days, until death or end-of-study, an average of 32 weeks)
- Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)(BL, every 28 days, until progression, death or end-of-study, an average of 32 weeks)
- Overall Survival - Time to Event(BL, every 28 days, until death or end-of-study, an average of 32 weeks)