Evaluation of the Irinotecan/Bevacizumab Association for Naive Unresectable Glioblastoma
NCT01022918
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
All the eligibility criteria must be met before registration :
- delay upper or equal to 14 days from stereotaxic biopsy and 28 days from surgical biopsy
- Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma)
- Patient belonging to the RPA V class or associated
- only supratentorial glioblastoma
- Diagnosis must be obtained by a stereotactic or surgical biopsy
- Age between 18 and 70
- A contrast-enhanced MRI must be performed within 28 days prior to study registration
- Total or partial surgical resection deemed as not possible by a neurosurgeon
- Karnofsky Index (KI) performance status over 50
- Life expectancy of at least 3 months
- A stable dose of corticosteroid for at least 7 days to control intracranial pressure and neurological symptoms
- Adequate blood function : absolute neutrophil count > 1.5 x 109/L, platelets count > 100 x 109/L platelets; hemoglobin > 10 g/dl after blood transfusion if required
- Adequate liver function: bilirubin < 1.5 ULN (upper limit of normal), ALT and AST < 2.5 ULN, Prothrombin rate > 75 %
- Adequate renal function: creatinine < 1.2 ULN; proteinuria test 0 or trace (or urine protein concentration < 1g/24h if proteinuria test is + or ++).
- Negative pregnancy test for women of childbearing potential and adequate contraception for men and women.
- systolic arterial blood pressure at rest ≤ 170 mmHg
- Patient must have been informed and must have signed the specific informed consent form.
- holder of a coverage by the health insurance
- patient belonging to the RPA III or IV
- prior malignant tumor in the recent 5 years or concomitant malignancy
- prior anti-tumoral chemotherapy or radiotherapy
- prior gross resection of the brain tumor
- patient receiving gliadel
- cardiovascular contra-indications to bevacizumab : prior angina pectoris, prior
myocardial infarction, prior brain stroke, even transient, distal severe arteriopathy,
uncontrolled high blood pressure
- anticomitial drug p450 cytochrome inductors
- other substances inducing p450 cytochrome
- proteinuria ≥ 1g/L
- concurrent anticoagulant or platelet anti-aggregant treatment
- congenital haemorrhagic pathology (haemophilia, Willebrandt)
- sign of brain haemorrhage on the RMI initial exam
- non resolved infectious disease
- non controlled arterial hypertension (≥170 mmHg)
- intracranial high pressure not controlled by a stable dose of steroids for at least 7
days
- pregnancy or refusal of the contraception for women and men
- psychiatric, behavioural disorders or geographical situation precluding the
administration or follow-up of the protocol (including claustrophobia)
- digestive haemorrhage and / or gastro-duodenal ulcer occurring in the last 3 months
- pregnant, nursing woman, or without contraception
- private individuals of freedom or under tutelage (including legal guardianship)
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Dijon, Bourgogne
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Evaluation of the Irinotecan/Bevacizumab Association for Naive Unresectable Glioblastoma | |||
Official Title ICMJE | Evaluation of the Irinotecan/Bevacizumab Association as Neo-adjuvant and Adjuvant Treatment of Chemoradiation With Temozolomide for Naive Unresectable Glioblastoma. Phase II Randomized Study With Comparison to Chemoradiation With Temozolomide | |||
Brief Summary | Treatment of glioblastoma (GBM) is based on surgery when possible, and chemoradiation with temozolomide, which became a standard since the EORTC study (Stupp, 2005). However, the prognosis of unresectable GBM remains poor despite chemoradiation with an estimated 10 month median survival, in the range of the comparable patients in the RPA class V from the EORTC study (Miramanoff, 2006). Vredenburgh et al. from the Duke University (Durham, NC) reported at ASCO 2006 (fully published in J Clin Oncol, 2007) a 57 % unexpected response rate using a bevacizumab/irinotecan schedule in patients with relapsed GBM or grade 3 astrocytomas. This unusual high response rate, sometimes with major and sustained responses, was confirmed by a cooperative french study of ANOCEF (Guiu et al., 2008). Such a major improvement of treatment effectiveness lead ANOCEF, which federates most of the active neuro-oncology teams in France, to propose a neo-adjuvant and adjuvant bevacizumab-based chemotherapy framing a standard temozolomide-based chemoradiation with the aim to improve the prognosis of unresectable GBM. The bevacizumab/temozolomide combination as neo-adjuvant is presently being evaluated by the Duke University. We believe that an ambitious comparison of the bevacizumab/irinotecan-schedule with the ''standard'' temozolomide-based chemoradiation is a fascinating challenge to improve the treatment of this awful disease. The ANOCEF proposal '' Evaluation of the irinotecan/bevacizumab association as neo-adjuvant and adjuvant treatment of chemoradiation with temozolomide for naive unresectable glioblastoma. Phase II randomized study with comparison to chemoradiation with temozolomide'' has been successfully granted by INCA (Institut National du Fancer, France) through its research program ( PHRC : Programme Hospitalier de Recherche Clinique). Implementation of this program is now starting . | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | |||
Condition ICMJE | Naive Unresectable Glioblastoma | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Chauffert B, Feuvret L, Bonnetain F, Taillandier L, Frappaz D, Taillia H, Schott R, Honnorat J, Fabbro M, Tennevet I, Ghiringhelli F, Guillamo JS, Durando X, Castera D, Frenay M, Campello C, Dalban C, Skrzypski J, Chinot O. Randomized phase II trial of irinotecan and bevacizumab as neo-adjuvant and adjuvant to temozolomide-based chemoradiation compared with temozolomide-chemoradiation for unresectable glioblastoma: final results of the TEMAVIR study from ANOCEF?. Ann Oncol. 2014 Jul;25(7):1442-1447. doi: 10.1093/annonc/mdu148. Epub 2014 Apr 9. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 134 | |||
Original Estimated Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | January 2011 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria: All the eligibility criteria must be met before registration :
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | France | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01022918 | |||
Other Study ID Numbers ICMJE | TemAvIr | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Centre Georges Francois Leclerc | |||
Study Sponsor ICMJE | Centre Georges Francois Leclerc | |||
Collaborators ICMJE |
| |||
Investigators ICMJE |
| |||
PRS Account | Centre Georges Francois Leclerc | |||
Verification Date | September 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |