Study With Pazopanib and Weekly Paclitaxel in Penile Carcinoma (PAZOPEN-SOGUG) (PAZOPEN-SOGUG)

This is an interventional treatment trial for Penile Squamous Cell Carcinoma Stage IV focused on measuring Penile squamous cell carcinoma, Pazopanib, Weekly paclitaxel Read More

Inclusion Criteria:

• Written informed consent
• Age >= 18 years
• Histologically confirmed diagnosis of squamous cell carcinoma of the penis
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
• Measurable disease criteria according to RECIST criteria (version 1.1)
• Progressive disease after treatment with cisplatin or carboplatin based chemotherapy.
• Archived tumor tissue must be provided for all subjects for biomarker analysis before and/or during treatment with investigational product.
• Adequate organ system function - Haemoglobin >= 9.0 gr/dl (5.6 mmol/L) and stable in the previous 4 weeks to start study treatment - Neutrophils >= 1.5 x 10*9/L - Platelets >= 100 x 10*9/L - Total bilirubin <= 1.5 x UNL - AST/SGOT and ALT/SGPT <= 2.5 x UNL - serum creatinine <= 1.5 mg/dL - Urine protein to creatinine ratio < 1.
• Normal coagulation tests: - Prothrombin time (PT) or international normalized ratio (INR) <= 1.2 X ULN - Activated partial thromboplastin time (aPTT) <= 1.2 X ULN 10. Are able to swallow and retain oral tablets

Exclusion Criteria:

• Prior malignancy.
• Central nervous system metastases at baseline, with the exception of those subjects who have previously-treated CNS metastases (surgery ± radiotherapy, radiosurgery, or gamma knife) and who meet both of the following criteria: a) are asymptomatic and b) have no requirement for steroids or enzyme-inducing anticonvulsants
• Clinically significant gastrointestinal abnormalities that may increase the risk for gastrointestinal bleeding.
• Clinically significant gastrointestinal abnormalities that may affect absorption of investigational product.
• Corrected QT interval (QTc) > 480 ms
• 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 >= 90 mmHg].
• History of cerebrovascular accident including transient ischemic attack (TIA), pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.
• Evidence of active bleeding or bleeding diathesis.
• Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that increase the risk of pulmonary hemorrhage
• Recent hemoptysis (>= 1/2 teaspoon [2.5 mL]) of red blood within 8 weeks before first dose of study drug).
• Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subjects safety, provision of informed consent, or compliance to study procedures.
• Unable or unwilling to discontinue use of prohibited medications 14 days prior to the first dose of study drug and for the duration of the study.
• 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 OR - chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days prior to the first dose of Pazopanib
• Administration of any non-oncologic investigational drug within 30 days prior to receiving the first dose of study treatment
• Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is progressing in severity, except alopecia.
• Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to pazopanib or paclitaxel and/or excipients that contraindicates their participation.
• Previous taxane or/and antiVEGF treatment would not allow patient to participate in the study.