Penile Squamous Cell Carcinoma Stage IV Clinical Trial
Official title:
Phase II Study With Pazopanib and Weekly Paclitaxel in Metastatic or Locally Advanced Squamous Penile Carcinoma Patients Previously Treated With Cisplatin Based Chemotherapy
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.
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Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment