Etude : GETUG AFU 24 / BEVABEL



ATTENTION : pour chaque essai clinique, les éléments affichés ci-dessous ne sont pas exhaustifs, et le protocole fourni par le promoteur reste l’unique document à consulter pour mener à bien un essai clinique sur centre. Pour plus d'informations, contactez le référent du territoire concerné.


Acronyme
Nom
Traitement
Dernière MÀJ
Présentation de l'étude
Acronyme : GETUG AFU 24

Nom : BEVABEL

Traitement : Métastasique ou localement avancé

Dernière MÀJ : 26/09/2017
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Etude prospective de phase II, non randomisée, d'évaluation de la gemcitabine associée à un sel de platine en combinaison avec le bevacizumab (Avastin®) dans le traitement des carcinomes métastatiques des tubes collecteurs

Spécialité : Voies urinaires
Localisation : C64 - Tumeur maligne du rein, à l'exception du bassinet
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : Open-label, non-randomized, multicenter, phase II, single arm non comparative trial evaluating toxicity and efficacy of gemcitabine plus platinium salt in combination with bevacizumab in first-line setting in metastatic collecting duct carcinoma.

Patients will be treated for a maximum of 6 (21 days) chemotherapy cycles (Gemcitabine+platinium salt+bevcizumab)

Phase : II

Stade : IV

1
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Patients should be aged ≥ 18years at the inclusion,
- Patients with histologically confirmed metastatic collecting duct carcinoma,
- Available tumor samples for centralized reading by anatomopathologist,
- Patients with or without nephrectomy,
- At least one measurable lesion as per RECIST criteria (RECIST v1.1),
- No prior chemotherapy nor anti-angiogenic drugs (naive patients),
- No irradiation within 4 weeks before inclusion,
- Absolute neutrophil counts (ANC) ≥ 1.5 x 109/L,
- Platelets ≥ 100 x 109/L,
- Hemoglobin ≥ 9 g/dL,
- Hepatic function : AST and ALT ≤ 1.5 x ULN (≤ 4 x ULN in case of liver metastases); total bilirubin ≤ 1.5 x ULN; alkaline phosphatase < 2 x ULN (≤ 4 x ULN in case of bone metastases),
- Renal function : creatinine clearance ≥ 60 mL/min (MDRD calculation method),
- Absence of proteinuria at baseline defined by < 0.3 g of protein on urine sample or < 0.5 g/24h00 on urine collection,
- Prothrombin time (TP) or partial thromboplastin time (PTT) strictly less than 50% deviation from normal limits, of international normalized ratio (INR) strictly below 2, Note: The use of full-dose oral or parenteral anticoagulants as well as aspirin or clopidogrel is permitted as long as the INR or a PTT is within therapeutic limits (according to the medical standard of the institution) and the patient has been on a stable dose of anticoagulants for at least two weeks at the time of study enrolment. - Prophylactic use of anticoagulants is allowed.
- ECG with normal sinus rhythm,
- ECOG Performance Status: 0 - 2,
- Estimated life expectancy ≥ 12 weeks,
- Patients who have received the information sheet, dated and signed the informed consent form,
- Patient of child-bearing potential (for female patient: study entry after a menstrual period and a negative pregnancy test) must agree to use two medically acceptable methods of contraception (one for the patient and one for the partner) during the study and for 6 months after the last study treatment intake.
- Patients must be willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures,
- Patients affiliated to the Social Security System,

Critères de non-inclusion : - Treatment with any other investigational agent, or participation in another clinical trial within 28 days prior to enrolment,
- Prior systemic treatment with chemotherapy or anti-angiogenic tyrosine kinase inhibitors such as axitinib, sunitinib, sorafenib, pazopanib, tivozanib, mTOR inhibitor (Temsirolimus or everolimus) and targeted VEGF drugs such as bevacizumab and VEGF trap,
- Evidence of current central nervous system (CNS) metastases or spinal cord compression. If CNS metastases are suspected, patient should undergo an MRI or CT-Scan of the brain (with contrast, if possible) within 28 days prior to inclusion,
- Another histological type of renal cancer
- Other malignancy within 3 years prior to inclusion (except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix, and/or pT1/a bladder cancer),
- Uncontrolled hypertension (≥ 160 mm Hg systolic and/or ≥ 90 mm Hg diastolic) while receiving medication,
- Cardio-vascular disorders: congestive heart failure ≥ NYHA II, myocardial infarction or coronary artery bypass graft in the previous six months, ongoing severe or unstable angina,
- LVEF value strictly less than 50%,
- Current or recent (within 2 weeks of study enrolment) initiation of aspirin, clopidogrel), oral or parenteral anticoagulants or thrombolytic agents for therapeutic purposes.
- History of clinically significant hemorrhagic or thromboembolic events in the past six months, or known inherited predisposition to bleeding or thrombosis or History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment; History of haemoptysis ≥ grade 2 (defined as ≥ 2.5 mL bright red blood per episode) within 1 month of study enrolment,
- Patients who underwent, according to the investigator, a significant surgery such as but not limited to , abdominal, thoracic or neurologic surgery within 28 days before the first treatment administration or patient with a wound that is not already healed at the first treatment administration or patients who underwent a minor surgical procedure including placement of a vascular access device, within 2 days of the first study treatment,
- Patients with active ulcer,
- Patients with untreated bone fracture,
- Peripheral neuropathy grade ≥ 2 (Toxicity Criteria-(CTCAE) v4.0),
- Patients with active infection requiring intravenous antibiotics at the time of first study treatment,
- In the opinion of the investigator, any evidence of other severe or uncontrolled systemic disease (e.g. unstable or uncompensated respiratory, cardiac, hepatic or renal disease), or any other acute or chronic medical condition that would make the patient inappropriate with this study,
- Immunocompromised patients, including known seropositivity for human immunodeficiency virus (HIV),
- Known hypersensitivity to any component of the investigational drugs or excipients,
- Pregnant or lactating women,
- Person deprived of their liberty or under judicial protection (including guardianship),
- Patients with significantly altered mental status prohibiting the understanding of the study or with psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule or any condition which, in the opinion of the investigator, would preclude participation in this trial. Those conditions should be discussed with the patient before registration in the trial.
NCT
Promoteur
Contact ARC
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
Unicancer (IGR)
Type de sponsor : Institutionnel
94800 VILLEJUIF

Contact ARC :

Coordonnateur :
Nicolas PECUCHET
nicolas.pecuchet@egp.aphp.fr
0156093471
Centre investigateur
Investigateur
TEC / ARC / IDE
État
Type d'étude
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Florence JOLY

TEC / ARC / IDE :
Jérémy BOUTROIS
j.boutrois@
baclesse.unicancer.fr

Ouverture de l'essai : CLOS

Type d'étude : Hors ciblage moléculaire / Hors innovation thérapeutique
MAJ : 26/03/2019