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

Information source: Spanish Oncology Genito-Urinary Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Penile Squamous Cell Carcinoma Stage IV

Intervention: Pazopanib (Drug); Paclitaxel (Drug)

Phase: Phase 2

Status: Not yet recruiting

Sponsored by: Spanish Oncology Genito-Urinary Group

Official(s) and/or principal investigator(s):
Miguel A Climent, MD, Study Director, Affiliation: Instituto Valenciano de Oncología

Overall contact:
Miguel A Climent, MD, Phone: +34 961114050, Email: macliment@fivo.org

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.

Clinical Details

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 design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Overall response rate

Secondary outcome:

Clinical benefit rate

Progression free survival

Response duration

Overall survival

Safety tolerability profile as measured by the number of events per patient

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Male.

Criteria:

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 may increase the risk for

gastrointestinal bleeding.

- Clinically significant gastrointestinal abnormalities that may affect absorption of

investigational product.

- Corrected QT interval (QTc) > 480 ms

- History of any one or more of the following cardiovascular conditions within the past

6 months: - Cardiac angioplasty or stenting - Myocardial infarction - Unstable angina

- Coronary artery bypass graft surgery - Symptomatic peripheral vascular disease -

Class III or IV congestive heart failure, as defined by the New York Heart Association (NYHA)

- Poorly controlled hypertension [defined as systolic blood pressure (SBP) of >= 140

mmHg or diastolic blood pressure (DBP) of >= 90 mmHg].

- History of cerebrovascular accident including transient ischemic attack (TIA),

pulmonary embolism or untreated deep venous thrombosis (DVT) within the past 6 months.

- Evidence of active bleeding or bleeding diathesis.

- Known endobronchial lesions and/or lesions infiltrating major pulmonary vessels that

increase the risk of pulmonary hemorrhage

- Recent hemoptysis (>= 1/2 teaspoon [2. 5 mL]) of red blood within 8 weeks before first

dose of study drug).

- Any serious and/or unstable pre-existing medical, psychiatric, or other condition

that could interfere with subjects safety, provision of informed consent, or compliance to study procedures.

- Unable or unwilling to discontinue use of prohibited medications 14 days prior to the

first dose of study drug and for the duration of the study.

- Treatment with any of the following anti-cancer therapies: - radiation therapy,

surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR

- chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal

therapy within 14 days prior to the first dose of Pazopanib

- Administration of any non-oncologic investigational drug within 30 days prior to

receiving the first dose of study treatment

- Any ongoing toxicity from prior anti-cancer therapy that is >Grade 1 and/or that is

progressing in severity, except alopecia.

- Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs

chemically related to pazopanib or paclitaxel and/or excipients that contraindicates their participation.

- Previous taxane or/and antiVEGF treatment would not allow patient to participate in

the study.

Locations and Contacts

Miguel A Climent, MD, Phone: +34 961114050, Email: macliment@fivo.org

Hospital de La Santa Creu I Sant Pau, Barcelona 08025, Spain; Not yet recruiting
Pablo Maroto, MD, Phone: +34 935565638, Email: jmaroto@santpau.es
Pablo Maroto, MD, Principal Investigator

Complejo Hospitalario Regional Reina Sofía, Córdoba 14004, Spain; Not yet recruiting
María J Méndez, MD, Phone: +34 957011448, Email: mjsemv@yahoo.es
María J Méndez, MD, Principal Investigator

Hospital Universitario Lucus Augusti, Lugo 27003, Spain; Not yet recruiting
Sergio Vazquez, MD, Phone: +34 982296459, Email: sergio.vazquez.estevez@sergas.es
Sergio Vazquez, MD, Principal Investigator

Hospital Clínico San Carlos, Madrid 28040, Spain; Not yet recruiting
Javier Puente, MD, Phone: +34 913303000, Ext: 7545, Email: javier.puente@salud.madrid.org
Javier Puente, MD, Principal Investigator

Hospital General Universitario J.M. Morales Meseguer, Murcia 30008, Spain; Not yet recruiting
Enrique González Billalabeitia, MD, Phone: +34 968360969, Email: lm.omcomorales@yahoo.es
Enrique González Billalabeitia, MD, Principal Investigator

Instituto Valenciano de Oncología, Valencia 46009, Spain; Not yet recruiting
Miguel A Climent, MD, Phone: +34 961114050, Email: macliment@fivo.org

Institut Català D'Oncologia L'Hospitalet, Hospitalet de Llobregat, Barcelona 08908, Spain; Not yet recruiting
Xavier García del Muro, MD, Phone: +34 932607332, Email: garciadelmuro@iconcologia.net
Xavier García del Muro, MD, Principal Investigator

Complejo Hospitalario de Navarra, Pamplona, Navarra 31008, Spain; Not yet recruiting
Nuria Lainez, MD, Phone: +34 848422576, Email: nuria.lainez.milagro@cfnavarra.es
Nuria Lainez, MD, Principal Investigator

Additional Information

Starting date: January 2015
Last updated: October 31, 2014

Page last updated: August 23, 2015

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