Status:
COMPLETED
An Open-label Phase II Study With SUTENT in Patients Suffering From Hormone Refractory Prostate Cancer
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Prostatic Neoplasms
Neoplasms, Hormone-Dependent
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
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 consecut...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00748358
Start Date
March 1 2008
End Date
April 1 2011
Last Update
September 18 2013
Active Locations (1)
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1
Service Oncologie Médicale, Hopital Europeen Georges Pompidou
Paris, France, 75015