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

Last updated: February 16, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

2

Condition

Glioblastoma Multiforme

Gliomas

Astrocytoma

Treatment

N/A

Clinical Study ID

NCT01474239
ML25739
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 radiotherapyand chemotherapy)

  • Adequate hematological, biochemical and organ functions

Exclusion

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, ofthe prostate or basal cell carcinoma)

  • Clinically significant cardiovascular diseases

Study Design

Total Participants: 91
Study Start date:
November 01, 2011
Estimated Completion Date:
December 31, 2013

Connect with a study center

  • Napoli, Campania 80131
    Italy

    Site Not Available

  • Bologna, Emilia-Romagna 40133
    Italy

    Site Not Available

  • Roma, Lazio 00168
    Italy

    Site Not Available

  • Genova, Liguria 16128
    Italy

    Site Not Available

  • Milano, Lombardia 20132
    Italy

    Site Not Available

  • San Giovanni Rotondo, Puglia 71013
    Italy

    Site Not Available

  • Terni, Umbria 05100
    Italy

    Site Not Available

  • Padova, Veneto 35128
    Italy

    Site Not Available

  • Treviso, Veneto 31100
    Italy

    Site Not Available

  • empty

    Ancona, 60126
    Italy

    Site Not Available

  • empty

    Messina, 98123
    Italy

    Site Not Available

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