A Study of Avastin (Bevacizumab) And Fotemustine in Patients With Recurrent Glioblastoma

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
First received: November 8, 2011
Last updated: June 1, 2015
Last verified: June 2015

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
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Experimental: Investigational Arm Drug: bevacizumab [Avastin]
10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01474239

Napoli, Campania, Italy, 80131
Bologna, Emilia-Romagna, Italy, 40133
Roma, Lazio, Italy, 00168
Genova, Liguria, Italy, 16128
Milano, Lombardia, Italy, 20133
Milano, Lombardia, Italy, 20132
San Giovanni Rotondo, Puglia, Italy, 71013
Terni, Umbria, Italy, 05100
Padova, Veneto, Italy, 35128
Treviso, Veneto, Italy, 31100
Sponsors and Collaborators
Hoffmann-La Roche
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 1, 2015
Health Authority: Italy: Ministry of Health

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2015