Know Cancer

forgot password

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

Phase 2
18 Years
Open (Enrolling)
Prostatic Neoplasms, Neoplasms, Hormone-Dependent, Tumor Markers, Biological, Survival Rate, Disease-Free Survival

Thank you

Trial Information

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

- 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

- 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

- Angiogenesis markers: bFGF, SDF-1, VEGF-A, VEGFR1 and VEGFR2, CECs and CEPs,
endothelial and platelet microparticles.

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

- 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

- 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

- Treatment with others investigational drugs or participation in another clinical
trial within the past 4 weeks, or concomitantly with this trial

Type of Study:


Study Design:

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

Outcome Measure:

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.

Outcome Time Frame:

18 months

Safety Issue:


Principal Investigator

stephane OUDARD, professor

Investigator Role:

Principal Investigator

Investigator Affiliation:

Assistance Publique - Hôpitaux de Paris


France: Ministry of Health

Study ID:




Start Date:

March 2008

Completion Date:

April 2011

Related Keywords:

  • Prostatic Neoplasms
  • Neoplasms, Hormone-Dependent
  • Tumor Markers, Biological
  • Survival Rate
  • Disease-Free Survival
  • metastatic prostate carcinoma
  • sunitinib [Substance Name]
  • Clinical Trial, Phase II [Publication Type]
  • Neoplasms
  • Neoplasms, Hormone-Dependent
  • Prostatic Neoplasms
  • Stress, Psychological