Status:
TERMINATED
Study With Pazopanib and Weekly Paclitaxel in Penile Carcinoma (PAZOPEN-SOGUG)
Lead Sponsor:
Spanish Oncology Genito-Urinary Group
Conditions:
Penile Squamous Cell Carcinoma Stage IV
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
Penile cancer is an uncommon disease, with devastating physical and psychological effects on patients. Penile carcinoma even in advanced stages is responsive to several chemotherapeutic agents. Howeve...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT02279576
Start Date
January 1 2015
End Date
September 1 2016
Last Update
October 14 2016
Active Locations (8)
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1
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, Spain, 08025
2
Institut Català D'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain, 08908
3
Complejo Hospitalario Regional Reina Sofía
Córdoba, Córdoba, Spain, 14004
4
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain, 27003