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Penile Squamous Cell Carcinoma Stage IVPhase 2PAZOPEN-SOGUGNCT02279576

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

A Phase 2 study testing Pazopanib and Paclitaxel in people with Penile Squamous Cell Carcinoma Stage IV, run by Spanish Oncology Genito-Urinary Group at 8 sites in Spain.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, men only
Conditions the study is for
Penile Squamous Cell Carcinoma Stage IV
What is being tested?
Pazopanib and Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
8 sitesSpain
Study dates
Jan 2015to Sep 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Spain8 sites

  • Hospital de La Santa Creu I Sant Pau

    Barcelona, Barcelona, 08025

  • Complejo Hospitalario Regional Reina Sofía

    Córdoba, Córdoba, 14004

  • Institut Català D'Oncologia L'Hospitalet

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario Lucus Augusti

    Lugo, Lugo, 27003

  • Hospital Clínico San Carlos

    Madrid, Madrid, 28040

  • Hospital General Universitario J.M. Morales Meseguer

    Murcia, Murcia, 30008

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Instituto Valenciano de Oncología

    Valencia, Valencia, 46009

Other trials in Spain

About this study

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.

Read more

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.

Being tested
Pazopanib, Paclitaxel
Keywords
Penile squamous cell carcinoma, Pazopanib, Weekly paclitaxel

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PazopanibDrug

    Also called Daily pazopanib

    Pazopanib 800mg/day continuously administered.

  • PaclitaxelDrug

    Also called Weekly paclitaxel

    Paclitaxel 65 mg/m2 in weekly administration 3 administrations (D1, D8 and D15) every 4 weeks period.

Study groups in NCT02279576
Study groupRoleWhat they receive
Pazopanib plus weekly paclitaxelExperimentalPazopanib 800mg /day continuously administered plus paclitaxel 65 mg/m2 in weekly administration, 3 administrations (D1, D8 and D15) every 4 weeks period.
Receives: Drug: Pazopanib; Drug: Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response rate

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

    Measured: Up to 6 months

Secondary outcomes (5)

  1. Clinical benefit rate

    Clinical benefit rate (complete and partial response and stable disease) evaluated according RECIST criteria version 1.1

    Measured: Up to 6 months

  2. Progression free survival

    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

    Measured: Up to 12 months

  3. Response duration

    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

    Measured: Up to 12 months

  4. Overall survival

    Time from patient inclusion to death assessed up to 18 months

    Measured: Up to 18 months

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

    Number of events per patient

    Measured: Up to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Oct 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionSep 2016
  4. Study completionSep 2016

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02279576
Sponsor's protocol ID
SOG-CPE-2014-03
Other IDs
2014-003127-22, 2014
Acronym
PAZOPEN-SOGUG
Status last verified
Nov 2015
First submitted
27 Oct 2014
Last updated
14 Oct 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pazopanib and Paclitaxel in people with Penile Squamous Cell Carcinoma Stage IV, run by Spanish Oncology Genito-Urinary Group at 8 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: The low recruitment of patients will not allow to complete the study with the required number of patients within reasonable time.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (time frame: Up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02279576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.

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