TerminatedPhase 2

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

Stopped: The low recruitment of patients will not allow to complete the study with the required number of patients within reasonable time.

Spain4 participantsStarted 2015-01

Plain-language 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 antiangiogenic drugs seem a very active treatment, combination of pazopanib and paclitaxel seems a good combination to be tested in patients with penile carcinoma.

Who can participate

Age range

18 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Overall response rate

Timeframe: Up to 6 months

Trial details

NCT IDNCT02279576

SponsorSpanish Oncology Genito-Urinary Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Penile Squamous Cell Carcinoma Stage IV trials