Phase I/II study on concomitant and adjuvant Temozolomide and Radiotherapy with or without PTK787/ZK222584 in newly diagnosed GBM
- Conditions
- Glioblastoma multiformeMedDRA version: 7.1Level: PTClassification code 10018337
- Registration Number
- EUCTR2004-003896-35-AT
- Lead Sponsor
- European Organisation for Research and Treatment of Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 220
? Histologically proven newly diagnosed GBM (according to local pathologist)
amenable to concomitant and adjuvant temozolomide treatment by investigator's
assessment.
? Interval between first surgery/biopsy and start of radiotherapy less than 6 weeks
(42 days) and interval from the last surgical procedure and the start of radiotherapy
more than 8 days (to allow healing prior to start of radiotherapy and adjuvant
treatment)
? Start of radiotherapy within 8 days of randomization
? No prior chemotherapy, radiotherapy or prior anti-VEGF therapy.
? Patients should not be receiving EIADs. Patients under EIADS should be switched
to no EIADs prior to study entry (refer to chapter 5.7).
? All patients (male and female) must use effective contraception if of reproductive
potential. Females must not be pregnant or lactating.
? ECOG Performance status < 2.
? Aged = 18 years and < 70 years.
? Patients must be on a stable or decreasing dose of corticosteroids for at least two
weeks.
? Normal haematological functions: neutrophils superior or equal to 1.5*109 cells/l,
platelets superior or equal to 100*109 cells/l.
? Normal liver functions: bilirubin < 1.5 times the upper limit of the normal range;
alkaline phosphatase and transaminases inferior to 2.5 the upper limit of the normal
range.
? Serum creatinine lower than or equal to 150 µmol/l (< 1.7mg/dl).
? Clinically normal cardiac function without history of ischaemic heart disease in the
past 6 months with normal 12 lead ECG and absence of uncontrolled cardiac
arrythmias. Patients must not have history of congenital long QT syndrome or a
baseline 12-lead ECG QTc of >450msec in males and >470msec in females. No
history of stroke.
? No previous or current malignancies at other sites with the exception of cone
biopsied carcinoma of the cervix and adequately treated basal or squamous cell
skin carcinoma.
? Absence of any unstable systemic diseases or active uncontrolled infections.
Absence of uncontrolled hypertension.
? No concomitant treatment with warfarine or other coumarine derivatives. No
concomitant treatment with other anti cancer agents and with any other
experimental treatment.
? Absence of any psychological, familial, sociological or geographical condition
potentially hampering compliance with the study protocol and follow-up schedule;
those conditions should be assessed with the patient before registration in the trial.
? Before patient registration/randomization, written informed consent must be given
according to ICH/GCP, and national/local regulations.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To assess activity of PTK787/ZK 222584 given concomitantly and as adjuvant to radiotherapy and temozolomide in newly diagnosed GBM by determining progression free survival at 6 months after documentation of toxicity profile of the combination.;Secondary Objective: ;Primary end point(s): For the phase I part:<br><br>To determine the safety / tolerance of PTK/ZK during the induction phase of treatment in combination with radiation therapy and temozolomide.<br><br>For the phase II part:<br><br>Progression free survival at 6 months.
- Secondary Outcome Measures
Name Time Method