Etude : TAPAZ /



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Acronyme
Nom
Traitement
Type d'étude
MÀJ
Présentation de l'étude
Acronyme : TAPAZ

Nom :

Traitement : Adjuvant

Type d'étude : Ciblage moléculaire / Innovation thérapeutique

Dernière MÀJ : 28/11/2017
Titre
Spécialité(s)
CIM10 - Localisation(s)
Informations principales
Titre : Essai randomisé de phase II évaluant l'association du Pazopanib au Paclitaxel hebdomadaire chez des patientes atteintes d'un cancer de l'ovaire en rechute précoce sous traitement d'entretien par bevacizumab

Spécialité : Seins, organes génitaux de la femme
Localisation : C56 - Tumeur maligne de l'ovaire

Spécialité : Tissu mésothélial et tissus mous
Localisation : C48 - Tumeur maligne du rétropéritoine et du péritoine
Schéma
Phase
Stade
Ligne(s)
Informations complémentaires
Schéma : A Randomized Phase II Study of Pazopanib and Weekly Paclitaxel in Patients With Platinum Resistant/Refractory Ovarian Cancer Who Relapse During Bevacizumab Maintenance

2 arms:
- Experimental: Pazopanib/Paclitaxel association
Pazopanib alone during 1 week at 600 mg (1x400mg and 1x200mg), per day, taken orally without food at least one hour before or two hours after a meal.
Then:
Pazopanib 600 mg (1x400mg and 1x200mg), per day, taken orally without food at least one hour before or two hours after a meal.
Paclitaxel 65 mg/m2 i.v. on days 1, 8, 15 every 28 days until progression of disease or toxicity

- Active Comparator: Paclitaxel alone
Paclitaxel 80mg/m2 i.v. on days 1, 8, 15
every 28 days until progression of disease or toxicity

Phase : II

Stade : NA

2, 3, 4
Critères d'inclusion
Critères de non-inclusion
Critères d'inclusion et de non-inclusion
Critères d'inclusion : - Age ≥ 18 years
- Performance status ECOG < 2
- Histological documented ovarian, tubal or peritoneum carcinoma (stage IC to IV)
- Patient treated at least with one line of platinum-based chemotherapy who have relapsed within 6 months after trhe last administration of platinum-based chemotherapy and taking bevacizumab for maintenance NB: Penultimate line of chemotherapy could contain chemotherapy without platinum and the last line should contain platinum-based chemotherapy (followed by bevacizumab for maintenance)
- Patients must have disease that is measurable and/or evaluable according to RECIST criteria and requires chemotherapy treatment
- Patients with liver metastasis can be included
- Subjects must provide written informed consent prior to performance of study-specific procedures or assessments and must be willing to comply with treatment and follow up.
- Life expectancy of more than 3 months
- Able to swallow and retain oral medication
- Adequate organ system function like: Total bilirubin ≤ 1.5 X ULN Alanine amino transferase (ALT) and Aspartate aminotransferase (AST)c ≤ 2.5 X ULN
- Subjects may not have had a transfusion within 7 days of screening assessment.
- Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation.
- Concomitant elevations in bilirubin and AST/ALT above 1.0 x ULN (upper limit of normal) are not permitted.
- If UPC <1, then a 24-hour urine protein must be assessed. Subjects must have a 24-hour urine protein value <1 g to be eligible. Use of urine dipstick for renal function assessment is not acceptable. 10. Women of childbearing potential must agree to use effective contraception 11. Negative serum pregnancy test (if applicable) 12. Affiliated to or a beneficiary of a social security category

Critères de non-inclusion : - Prior malignancy over the past 5 years with the exception of in situ carcinomas of the cervix or basal and squamous cell carcinoma or nonmelanoma skin cancer properly treated, or all solid tumor, considered as in completed remission without relapse for at least 5 years
- Central nervous system (CNS) metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants of P3A4 cytochrom
- Previous treatment with monotherapy weekly paclitaxel
- Previous treatment with bevacizumab within three weeks before start of studt treatment
- Patients with severe hypersensitivity to a product containing castor oil polyoxyl 35 or paclitaxel solvent: the Chremophor
- Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding including, but not limited to:
-> Active peptic ulcer disease
-> Known intraluminal metastatic lesion/s with risk of bleeding
-> Inflammatory bowel disease (e.g. ulcerative colitis, Chrohn's disease), or other gastrointestinal conditions with increased risk of perforation
-> History of abdominal fistula, gastrointestinal perforation, or intra abdominal abscess within 28 days prior to beginning study treatment.
- Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product including, but not limited to:
-> Malabsorption syndrome
-> Major resection of the stomach or small bowel.
- Corrected QT interval (QTc) > 450 msecs or > 480 msecs for patient with block branch
- History of any one or more of the following cardiovascular conditions within the past 6 months:
-> Cardiac angioplasty or stenting
-> Myocardial infarction
-> Unstable angina
-> Coronary artery bypass graft surgery
-> Symptomatic peripheral vascular disease
-> Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)
-> Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg].
- History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months. Note: Subjects with recent DVT who have been treated with therapeutic anti-coagulating agents for at least 6 weeks are eligible
- Major surgery or trauma within 28 days prior to first dose of investigational product and/or presence of any non-healing wound, fracture, or ulcer (procedures such as catheter placement not considered to be major surgery).
- 12 to 14: All risk of bleeding
- Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject's safety, provision of informed consent, or compliance to study procedures. 16 Unable or unwilling to discontinue use of prohibited medications 17 Treatment with any of the following anti-cancer therapies:
-> radiation therapy, surgery or tumor embolization within 14 days prior to the first dose of pazopanib (out of bevacizumab) OR
-> chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib (out of bevacizumab) 18 Administration of any non-oncologic investigational drug within 30 days or 5 half lives whichever is longer prior to receiving the first dose of study treatment 19 Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia. 20 Patient deprived of liberty or state-controlled 21 Inability to participate to medical follow up for geographic
NCT
Promoteur
Coordonnateur
Informations relatives au promoteur
NCT :
Promoteur :
ARCAGY-GINECO
Type de sponsor : Institutionnel
75004 PARIS 04

Coordonnateur :
Centre investigateur
Investigateur
TEC / ARC / IDE
État
MÀJ
Informations relatives aux investigateurs
Centre investigateur :
Centre François BACLESSE - 3 avenue du Général Harris - 14000 CAEN

Investigateur :
Florence JOLY

TEC / ARC / IDE :
Astrid LETIEMBRE
a.letiembre@
baclesse.unicancer.fr

Ouverture de l'essai : CLOS

MAJ : 08/02/2019