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. However, due to the low incidence of penile cancer, no large studies have been reported concerning chemotherapy. Various single agents were tested for activity en penile cancer in de 70s and 80s. Response rates ranged from 10 to 27% with cisplatin, 20 to 21% with bleomycin, and 0-62% with methotrexate. These agents in combination were tested in different studies. Other chemotherapy schemes have been studied, as combination of cisplatin with 5 fluorouracil with or without taxol, and cisplatin plus irinotecan. All of them in limited phase II studies, with described higher responses rates in some of them but without results confirmation in phase III studies. In conclusion, tested regimens so far have not been very successful in advanced stages of the disease. Antiangiogenic therapy has been demonstrated effective in the treatment of similar cancer types as lung and head and neck, so it can be postulated that antiangiogenic therapy can be effective in the treatment of penile carcinoma. Pazopanib is a new potent oral antiangiogenic therapy. Cytotoxic agents, such as paclitaxel, when administered at low doses and frequent intervals, may exert antiangiogenic effects, thereby enhancing anticancer activity. Recently, combination of pazopanib and paclitaxel administered in a metronomic schedule (80mg/m2 weekly 3 weeks every 4 weeks cycle) obtained a 40% response rate and an 80% of disease control in the first-line treatment of melanoma patients. Treatment was well tolerated. As paclitaxel and antiangiogenic drugs seem a very active treatment, combination of pazopanib and paclitaxel seems a good combination to be tested in patients with penile carcinoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Pazopanib 800mg/day continuously administered.
Paclitaxel 65 mg/m2 in weekly administration 3 administrations (D1, D8 and D15) every 4 weeks period.
Hospital de La Santa Creu I Sant Pau
Barcelona, Barcelona, Spain
Institut Català D'Oncologia L'Hospitalet
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Regional Reina Sofía
Córdoba, Córdoba, Spain
Hospital Universitario Lucus Augusti
Lugo, Lugo, Spain
Hospital Clínico San Carlos
Madrid, Madrid, Spain
Hospital General Universitario J.M. Morales Meseguer
Murcia, Murcia, Spain
Complejo Hospitalario de Navarra
Pamplona, Navarre, Spain
Instituto Valenciano de Oncología
Valencia, Valencia, Spain
Overall response rate
Evaluate response rate in terms of complete and partial response (RECIST criteria version 1.1)
Time frame: Up to 6 months
Clinical benefit rate
Clinical benefit rate (complete and partial response and stable disease) evaluated according RECIST criteria version 1.1
Time frame: Up to 6 months
Progression free survival
Time from patient inclusion until progression disease (RECIST criteria version 1.1) or death from any cause, whichever came first, assessed up to 12 months
Time frame: Up to 12 months
Response duration
Time from first response to progression disease (RECIST criteria version 1.1) or death from any cause, whichever came first, assessed up to 12 months
Time frame: Up to 12 months
Overall survival
Time from patient inclusion to death assessed up to 18 months
Time frame: Up to 18 months
Safety tolerability profile as measured by the number of events per patient
Number of events per patient
Time frame: Up to 6 months
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