A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01474239
First received: November 8, 2011
Last updated: June 3, 2013
Last verified: June 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Glioblastoma Multiforme |
Drug: bevacizumab [Avastin] Drug: fotemustine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Non Comparative Phase II Trial With Bevacizumab and Fotemustine in the Treatment of Recurrent Glioblastoma |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Overall Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Progression-free Survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Overall Survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Objective Response Rate [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Median Progression-free Survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Median Overall Survival [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Safety (Incidence of Adverse Events) [ Time Frame: 9 months ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: 9 months ] [ Designated as safety issue: No ]
| Enrollment: | 91 |
| Study Start Date: | November 2011 |
| Estimated Study Completion Date: | November 2014 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Investigational Arm |
Drug: bevacizumab [Avastin]
10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity
|
| Experimental: Calibration Arm |
Drug: fotemustine
75 mg/m2 intravenously on days 1, 8 and 15 followed by, after a 5 weeks interval, 100 mg/m2 on day 1 of a 3-weeks cycle. Until disease progression or unacceptable toxicity
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01474239
Locations
| Italy | |
| Bologna, Italy, 40133 | |
| Genova, Italy, 16128 | |
| Milano, Italy, 20132 | |
| Milano, Italy, 20133 | |
| Napoli, Italy, 80131 | |
| Padova, Italy, 35128 | |
| Roma, Italy, 00168 | |
| San Giovanni Rotondo, Italy, 71013 | |
| Terni, Italy, 05100 | |
| Treviso, Italy, 31100 | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
No publications provided
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01474239 History of Changes |
| Other Study ID Numbers: | ML25739 |
| Study First Received: | November 8, 2011 |
| Last Updated: | June 3, 2013 |
| Health Authority: | Italy: Ministry of Health |
Additional relevant MeSH terms:
|
Glioblastoma Astrocytoma Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
Fotemustine Bevacizumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors |
ClinicalTrials.gov processed this record on June 17, 2013