A PHASE II STUDY OF sunitinib IN PATIENTS WITH ADVANCED HORMONE RESISTANT AND CHEMOTHERAPY RESISTANT PROSTATE CANCER.
- Conditions
- Patients with advanced hormone resistant and chemotherapy resistant prostate cancer.
- Registration Number
- EUCTR2008-005033-29-GR
- Lead Sponsor
- Vassilis Georgoulias, Prof. of Internal Medicine-Oncology of Medical Dpt University of Crete
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- Not specified
1.Histologically or cytologically confirmed prostate cancer in relapse
2.Laboratory confirmation of hormone resistance by measuring LH, FSH, DHEA, testosterone.
3.Continued increase of PSA despite adequate androgen blockade and administration of at least one line of chemotherapy (docetaxel, vinorelbine).
4.ECOG Performance Status 0, 1 or 2 (see Appendix I)
5.Patients must be >18 and =80 years
6.Life expectancy =3 months
7.Provision of informed consent
8.Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
Patients with both measurable and non measurable disease will be allowed to enter the trial and will be followed for response as described in Section 6.1.1 of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1.Concomitant use of any other antineoplastic treatment with the exception of LHRH inhibitors and bisphosphonates for the treatment of bone metastases
2.Chronic active hepatitis or cirrhosis
3.Active infection, cachexia or serious psychiatric disease
4.Isolated recurrent disease that may be amenable to local therapy eg, surgical intervention or radiation therapy
5.Major surgery, radiation therapy, or systemic therapy within 4 weeks of starting the study treatment.
6.Diagnosis of any second malignancy, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months.
7.Any of the following within the 12 months prior to starting the study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
8.Ongoing cardiac dysrhythmias of grade ?2, atrial fibrillation of any grade, or QTc interval >450 msec for males or >470 msec for females.
9.Hypertension that cannot be controlled by medications (>150/100 mm/Hg despite optimal medical therapy).
10.Current treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed).
11.Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness.
12.Concurrent treatment with other experimental drugs and/or anticancer agents
13.Patients must be surgically sterile, or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate.
14.Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into the trial
15.Any unresolved chronic toxicity greater than CTC grade 2 from previous anticancer therapy
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the efficacy of Sunitinib in patients with advanced hormone resistant and chemotherapy resistant prostate cancer in terms of response rate.;Secondary Objective: To evaluate the efficacy of Sunitinib in patients with advanced hormone resistant and chemotherapy resistant prostate cancer in terms of Time To Progression and Survival;Primary end point(s): Primary endpoint:<br>•Objective Response Rate (ORR)<br><br>Secondary endpoint:<br>•Survival <br>•Time to Progression (TTP)<br>•Safety<br><br>Exploratory endpoint<br>•Plasma protein levels (including but not limited to VEGF, and sVEGFR2) that may be associated with tumor proliferation, angiogenesis, or sunitinib mechanism of action<br>
- Secondary Outcome Measures
Name Time Method