Phase 2
Completed N=91
A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma
Source: ClinicalTrials.gov NCT01474239 ↗Enrolled (actual)
91
Serious AEs
25.3%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants Alive 6 Months After Start of Treatment — 62.07; 73.33 percentage of participants — p=0.4291
Summary
This randomized, non-comparative study will evaluate the efficacy and safety of Avastin (bevacizumab) in patients with recurrent glioblastoma. Patients will be randomized to receive Avastin 10 mg/kg intravenously every 2 weeks or fotemustine 75 mg/m2 on days 1, 8 and 15, followed by, after a 5 weeks interval, 100 mg/m2 intravenously every 3 weeks. Treatment with fotemustine serves as a calibration arm and no formal efficacy comparison will be made between the two treatment arms. The anticipated time of study treatment is until disease progression or unacceptable toxicity.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Alive 6 Months After Start of Treatment |
62.07; 73.33 | 0.4291 |
| PRIMARY Overall Survival (OS) |
7.26; 8.66 | — |
| SECONDARY Percentage of Participants Who Were Alive and Progression Free 6 Months After Start of Treatment |
26.32; 10.71 | — |
| SECONDARY Progression-Free Survival (PFS) |
3.38; 3.45 | — |
| SECONDARY Percentage of Participants Alive 9 Months After Start of Treatment |
37.93; 46.67 | — |
| SECONDARY Percentage of Participants Alive 12 Months After Start of Treatment |
25.86; 40.00 | — |
| SECONDARY Percentage of Participants Alive 30 Days After Last Dose of Study Drug |
93.10; 90.00 | — |
| SECONDARY Percentage of Participants With a Best Overall Response of Complete Response (CR) or Partial Response (PR) |
28.81; 9.38; 28.81; 6.25 | — |
| SECONDARY Change From Screening in European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) Scores at Weeks 8, 16, 24, 32, 40, 48, 56, 64, and 72 |
71.95; 78.92; 10.37; 7.08; 7.56; 8.57 | — |
| SECONDARY Percentage of Participants With Corticosteroid Initiation During the Study Period |
58.82; 41.67 | — |
| SECONDARY Time to Corticosteroid Initiation |
4.49; 5.93 | — |
| SECONDARY Percentage of Participants in Each Class of Corticosteroid Use |
17.31; 17.86; 23.08; 21.43; 59.62; 60.71 | — |
| SECONDARY Percentage of Participants With Karnofsky Performance Status (KPS) Deterioration |
18.92; 14.29 | — |
| SECONDARY Time to Karnofsky Performance Status (KPS) Deterioration |
NA; NA | — |
| SECONDARY Percentage of Participants With World Health Organization (WHO) Performance Status (PS) Deterioration |
47.46; 37.50 | — |
| SECONDARY Time to WHO PS Deterioration |
8.87; NA | — |
Eligibility Criteria
Inclusion Criteria
- Adult patients, >/=18 years of age
- Diagnosis of recurrent glioblastoma multiforme (Grade IV)
- Previous treatment with temozolomide and radiotherapy
- First recurrence after standard adjuvant treatment (surgery, followed by radiotherapy and chemotherapy)
- Adequate hematological, biochemical and organ functions
Exclusion Criteria
- Previous treatment with Avastin or other anti-angiogenic drugs
- Residual relevant toxicity resulting from previous therapy
- Radiotherapy within the 3 months prior to the diagnosis of disease progression
- Chemotherapy in the previous 4 weeks
- Other active or inactive malignancies (except for carcinoma in situ of the cervix, of the prostate or basal cell carcinoma)
- Clinically significant cardiovascular diseases
Data sourced from ClinicalTrials.gov (NCT01474239). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.