A comparison of continuous Avastin treatment or placebo in addition to lomustine followed by standard treatment for worsening brain cancer

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 300

Inclusion Criteria

• Are currently enrolled in Study MO28347 and have provided additional consent following amendment 6 to the protocol, which changed the study from a Phase IIIb to a Phase II study
• Age = 18 years .
• Karnofsky performance status (KPS) = 60.
• Newly diagnosed, histologically confirmed glioblastoma not previously treated with chemotherypy or radiotherapy
• If female and not postmenopausal (< 12 months of amenorrhea) or surgically sterile, must agree to use a highly effective contraceptive method during the treatment period and for at least 6 months after the last dose of study drug
• Mandatory tissue collection during pre-study surgery or biopsy for confirmation of the diagnosis and pathology.
• Craniotomy or intracranial biopsy site must be adequately healed. Study treatment should be initiated > 28 days following the last surgical procedure.

Principal eligibility criteria at the time of randomisation (following PD1):
• Documented disease progression (PD1)
• Eligibility for 2nd-line treatment with lomustine and bevacizumab as investigational medicinal products.
• Patients for whom operation or re-operation is indicated before 2nd-line starts, tissue submission is mandatory
• Eastern Cooperative Oncology Group (ECOG) performance status is 0-2 when starting 2nd-line treatment
• Bevacizumab was well tolerated and treatment interruption lasted not more than 60 days

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 66

Exclusion Criteria

• Any prior chemotherapy for GBM and low grade astrocytomas.
• Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field.
• Prior or current anti-angiogenic treatment
•Treatment with any other investigational drug within 28 days or 2 investigational agent half-lives (whichever is longer) prior to first study treatment
• Inadequate hematological, renal or liver function
• Inadequately controlled hypertension
• Prior history of gastrointestinal perforation or abscess
• Clinically significant cardiovascular disease, NYHA >/= Grade II congestive heart failure, or serious cardiac arrhythmia uncontrolled by medication or potentially interfering with protocol treatment
• History or evidence of central nervous system disease unrelated to cancer unless adequately treated with standard medical therapy
• History or evidence of inherited bleeding diathesis or significant coagulopathy at risk of bleeding
• Serious non-healing wound, active ulcer, or untreated bone fracture
• Known hypersensitivity to any component of Avastin/placebo or any of the study drugs
• Active infection requiring intravenous antibiotics at start of study treatment
• Other malignancy within 5 years prior to study enrollment, except for carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or ductal carcinoma in situ treated with curative intent
• Pregnant or lactating women
• Participation in any other study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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