Study With Pazopanib and Weekly Paclitaxel in Penile Carcinoma (PAZOPEN-SOGUG) (PAZOPEN-SOGUG)
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|ClinicalTrials.gov Identifier: NCT02279576|
Recruitment Status : Terminated (The low recruitment of patients will not allow to complete the study with the required number of patients within reasonable time.)
First Posted : October 31, 2014
Last Update Posted : October 14, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Penile Squamous Cell Carcinoma Stage IV||Drug: Pazopanib Drug: Paclitaxel||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Pazopanib plus weekly paclitaxel
Pazopanib 800mg /day continuously administered plus paclitaxel 65 mg/m2 in weekly administration, 3 administrations (D1, D8 and D15) every 4 weeks period.
Pazopanib 800mg/day continuously administered.
Other Name: Daily pazopanib
Paclitaxel 65 mg/m2 in weekly administration 3 administrations (D1, D8 and D15) every 4 weeks period.
Other Name: Weekly paclitaxel
- Overall response rate [ Time Frame: Up to 6 months ]Evaluate response rate in terms of complete and partial response (RECIST criteria version 1.1)
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279576
|Institut Català D'Oncologia L'Hospitalet|
|Hospitalet de Llobregat, Barcelona, Spain, 08908|
|Complejo Hospitalario de Navarra|
|Pamplona, Navarra, Spain, 31008|
|Hospital de La Santa Creu I Sant Pau|
|Barcelona, Spain, 08025|
|Complejo Hospitalario Regional Reina Sofía|
|Córdoba, Spain, 14004|
|Hospital Universitario Lucus Augusti|
|Lugo, Spain, 27003|
|Hospital Clínico San Carlos|
|Madrid, Spain, 28040|
|Hospital General Universitario J.M. Morales Meseguer|
|Murcia, Spain, 30008|
|Instituto Valenciano de Oncología|
|Valencia, Spain, 46009|
|Study Director:||Miguel A Climent, MD||Instituto Valenciano de Oncología|