An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer (PROSUT)

September 17, 2013 updated by: Assistance Publique - Hôpitaux de Paris

An Open Label Phase II Study of Oral Treatment With Sunitinib (SUTENT) in Patients Suffering From Hormone Refractory Prostate Cancer After Progression With Docetaxel Based Regimen

as second-line treatment in metastatic prostate cancer, the present study will investigate the efficacy of sunitinib (SUTENT) given orally at a dose of 37.5 mg continuously, for 6 cycles of 6 consecutive weeks .Patients who are still responders after 6 cycles will be treated until disease progression, pain progression, unacceptable toxicity or death due to any cause.

Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.

Follow-up for up to 1 year from the last dose of sunitinib.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  • Antitumor efficacy of sunitinib will be assessed as follows:

    • PSA response rate and PSA progression according Working Group Criteria,
    • Variation of PSA doubling time (PSADT) before and after initiation of the treatment,
    • Objective response rate (ORR) according to RECIST criteria,
    • Clinical benefit,
    • Overall survival (OS).
  • Pharmacokinetic endpoints will include sunitinib and its metabolite, SU012662, plasma levels and estimation of the population pharmacokinetic parameters as well as the inter-individual variability of these parameters, for a subgroup of 30 patients.

  • The biological effects of sunitinib in patients with metastatic prostate carcinoma will be evaluated by measurements of the different biological markers that could be modulated by this antiangiogenic therapeutic, and could then predict and monitor disease progression and response to treatment:

    • Bone tumor markers: bone resorption markers (uCTX, uCTX, ICTP, CTX-MMP and TRACP-5b), bone formation markers (OC, PINP and BALP), osteoclastogenesis markers (OPG and RANKL) and parameters as calcium, phosphate, creatinine, albumin, PTH and 25(OH)D.
    • Angiogenesis markers: bFGF, SDF-1, VEGF-A, VEGFR1 and VEGFR2, CECs and CEPs, endothelial and platelet microparticles.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Service Oncologie Médicale, Hopital Europeen Georges Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Signed and dated IRB/EC-approved informed consent
  • Age 18 years or older
  • Histologically confirmed prostate adenocarcinoma
  • Metastatic HRPC
  • Received prior castration by orchidectomy and/or LH-RH agonist with or without antiandrogen, antiandrogen withdrawal, monotherapy with estramustine, or other hormonal agents.
  • Tumor disease must be progressive after a first line using docetaxel based chemotherapy, eventually in association with estramustine. Docetaxel based regimen may have been interrupted and restarted. Patient must have either measurable (RECIST criteria) or non-measurable (bone) disease and/or clinical progression (bone pain) and/or biological progression (PSA Working Group criteria).
  • Discontinuation from previous chemotherapy and/or radiation therapy at least 4 weeks prior to treatment initiation
  • Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) scale
  • Patient of child bearing potential must use effective contraception. Female partners of treated patients with child bearing potential must use oral contraceptives or intra uterine device (IUD)
  • Life expectancy of at least 3 months
  • Resolution of all acute toxic effects of any prior local treatment to NCI CTCAE grade 1
  • Patients must have adequate organ functions defined
  • Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  • Patient covered by the National Health System

Exclusion Criteria:

  • Prior treatment with sunitinib or other antiangiogenic agent
  • More than 1 line of chemotherapy
  • External beam radiotherapy for ≥ 50% of bone marrow
  • Uncontrolled hypertension (systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg despite optimal medical management)
  • Any of the following within 12 months prior to treatment initiation: severe/unstable angina, myocardial infarction, coronary artery bypass graft, symptomatic congestive heart failure, thrombotic or embolic events such as cerebrovascular accident including transient ischemic attack
  • Ongoing cardiac dysrhythmias of grade 2, atrial fibrillation of any grade
  • Treatment with anticonvulsant agents and treatment with therapeutic doses of coumarin-derivative anticoagulants such as warfarin currently or within 2 weeks prior to first day of Sunitinib administration. Low dose of warfarin for deep vein thrombosis prophylaxis is permitted (up to 2 mg/day) and low molecular weight heparin is allowed
  • Any medical condition that might interfere with oral medication absorption
  • Known or suspected brain metastasis, or carcinomatous meningitis, or spinal cord compression
  • Diagnosis of any second malignancy within the last 3 years, with the exception of treated basal cell or squamous cell carcinoma and pT1/a bladder cancer with no evidence of recurrent disease for 12 months
  • Any acute or chronic medical or psychiatric disorder incompatible with the study
  • Known human immunodeficiency virus or acquired immunodeficiency syndrome-related illness
  • Treatment with others investigational drugs or participation in another clinical trial within the past 4 weeks, or concomitantly with this trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: drug
Drug: sunitinib
37.5 mg orally once daily, continuously, for 6 cycles of 6 consecutive weeks.Dose increase or reduction of 12.5 mg increments and change of schedule is recommended based on individual safety and tolerability.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
progression-free survival (PFS) defined as the time from start of study treatment to first documentation of objective progressive disease, pain progression or to death on-study due to any cause.
Time Frame: 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence and intensity of Adverse Events (NCI CTCAE version 3.0).
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: stephane OUDARD, professor, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

September 5, 2008

First Submitted That Met QC Criteria

September 5, 2008

First Posted (Estimate)

September 8, 2008

Study Record Updates

Last Update Posted (Estimate)

September 18, 2013

Last Update Submitted That Met QC Criteria

September 17, 2013

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P070404

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Prostatic Neoplasms

Clinical Trials on sunitinib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Taiwan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe