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

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Phase II Study With Pazopanib and Weekly Paclitaxel in Metastatic or Locally Advanced Squamous Penile Carcinoma Patients Previously Treated With Cisplatin Based Chemothera

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. 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 an

Detailed Summary:
Sponsor: Spanish Oncology Genito-Urinary Group

Current Primary Outcome: Overall response rate [ Time Frame: Up to 6 months ]

Evaluate response rate in terms of complete and partial response (RECIST criteria version 1.1)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical benefit rate [ Time Frame: Up to 6 months ]
    Clinical benefit rate (complete and partial response and stable disease) evaluated according RECIST criteria version 1.1
  • Progression free survival [ Time Frame: Up to 12 months ]
    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
  • Response duration [ Time Frame: Up to 12 months ]
    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
  • Overall survival [ Time Frame: Up to 18 months ]
    Time from patient inclusion to death assessed up to 18 months
  • Safety tolerability profile as measured by the number of events per patient [ Time Frame: Up to 6 months ]
    Number of events per patient


Original Secondary Outcome: Same as current

Information By: Spanish Oncology Genito-Urinary Group

Dates:
Date Received: October 27, 2014
Date Started: January 2015
Date Completion:
Last Updated: October 13, 2016
Last Verified: November 2015