PAZOPANIB Efficacy and Tolerance in Desmoids Tumors

Exclusion Criteria

• •1. Personal history of malignancy except:
• •1. Cervical intraepithelial neoplasia;
• •2. Skin basal cell carcinoma;
• •3. Treated localized prostate carcinoma with PSA \<1;
• •4. Neoplasia treated with curative intent, in remission for at least five years and considered at low risk of relapse.
• •2. Pretreatement by Pazopanib or Methotrexate - vinblastine;
• •3. Known allergy to Pazopanib, Methotrexate or vinblastine;
• •4. Histological sampling not available for review or biological study;
• •5. Clinical abnormalities which may increase the risk of gastric bleeding (not exhaustive list);
• •1. Gastric tumor with known risk of bleeding;
• •2. Inflammatory bowel disease or other gastrointestinal disease may increase the risk of gastric perforation.
• •6. Pathologies that can lead to impaired intestinal absorption (not exhaustive):
• •1. Malabsorption;
• •2. Major resection of small intestine or stomach.
• •7. Active uncontrolled infectious disease;
• •8. Corrected QT interval\> 480 ms;
• •9. History of cardiovascular disease in the last 6 months:
• •1. Cardiac angioplasty;
• •2. Myocardial infarction;
• •3. Unstable angina;
• •4. Bypass surgery;
• •5. Symptomatic arterial disease.
• •10. Congestive heart failure grade II, III or IV according to the New York Hearth Association (NYHA) classification;
• •11. Uncontrolled arterial hypertension (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg);
• •12. History of stroke or transient ischemic attack, pulmonary embolism or deep vein thrombosis not treated, within 6 months;
• •13. History of major surgery or trauma within 28 days prior the first day of treatment, or presence of a wound, fracture or non-healed ulcer;
• •14. Evidence of active bleeding or bleeding tendency;
• •15. Known endobronchial lesions and / or infiltrative lesions of the large vessels lung;
• •16. History of hemoptysis of more than 2.5 ml in the eight weeks preceding the first day of chemotherapy;
• •17. Pulmonary dysfunction, asthma, emphysema, chronic obstructive pulmonary bronchitis, pneumonia, pneumothorax, pulmonary contusion, hemothorax, distress acute respiratory syndrome, pulmonary fibrosis;
• •18. Severe renal dysfunction;
• •19. Severe hepatic dysfunction;
• •20. History of psoriasis, rheumatoid arthritis, alcoholism, illness or chronic liver dysfunction;
• •21. Any pre-existing severe or unstable medical or psychiatric condition, or other condition that may interfere with patient safety, the collection of its informed consent or adherence to treatment;
• •22. Patient who refused or could not stop taking banned drugs for at least 14 days (or 5 half-lives of the drug) before the first day of start of chemotherapy and for the duration of the study;
• •23. During cancer treatment:
• •1. Radiotherapy, surgery or tumor embolization within 14 days before the 1st dose of pazobanib (arm A) or chemotherapy methotrexate, vinblastine (arm B);
• •2. Chemotherapy, immunotherapy, biological treatment, experimental or hormone therapy within 14 days or 5 half-lives of medication before the first day of the pazopanib (arm A) or chemotherapy with methotrexate, vinblastine (arm B).
• •24. History of cancer treatment toxicity\> grade 1 and / or whose the intensity increases, outside of alopecia.
• •25. Pregnancy and lactation
• •26. Concomitant treatment which can't be interrupted or replaced and which is not indicated with methotrexate:
• •1. Probenecid (alone or associated with sulfamethoxazole),
• •2. Trimethoprim,
• •3. Acetylsalicylic acid (for methotrexate doses above 20 mg per week with the acetylsalicylic acid and used at doses analgesics or antipyretics (≥ 500 mg per dose and/or \<3 g per day)or anti-inflammatory (≥ 1 g per dose and / or \> 3 g per day),
• •4. Phenylbutazone,
• •5. Yellow fever vaccine.