A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Aflibercept Versus Placebo Administered Every 3 Weeks in Patients Treated with Docetaxel / Prednisone for Metastatic Androgen-Independent Prostate Cancer - VENICE

• Conditions: Patients with metastatic androgen-independent prostate cancer

• Registration Number: EUCTR2006-004756-20-DK
• Lead Sponsor: sanofi-aventis recherche & développement

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07-24
• Last Update Posted: 19 November 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 1200

Inclusion Criteria

1. Histologically- or cytologically-confirmed prostate adenocarcinoma.
2. Metastatic disease.
3. Progressive disease while receiving hormonal therapy or after surgical castration documented by at least one of the following:
- Increase in measurable disease, and/or
- Appearance of new lesions, including those on bone scan (=2 new lesions) consistent with progressive prostate cancer, and/or
- Rising PSA defined as 2 sequential increases above a previous lowest reference value (see details in section 7.2, Figure 5- Defining rising PSA). Each value must be obtained at least 1 week apart. A PSA value of at least 2 ng/ml is required at study entry.
4. Effective castration (serum testosterone levels ? 50 ng/dL) by orchiectomy and/or LHRH agonists with or without anti-androgens. If the patient has been treated with LHRH agonists (i.e., without orchiectomy), then this therapy should be continued. If patients were either started on complete androgen blockade, or had a PSA response (defined by any reduction in PSA sustained for at least 3 months) after adding an antiandrogen, prior anti-androgen therapy should be stopped before randomization: at least 6 weeks for bicalutamide and nilutamide, and at least 4 weeks for flutamide, megestrol acetate and any other hormonal therapy.
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

Exclusion Criteria

- Related to methodology:
1. Prior cytotoxic chemotherapy for prostate cancer, except estramustine and except adjuvant/neoadjuvant treatment completed > 3 years ago.
2. Less than 28 days elapsed from prior treatment with estramustine, radiotherapy, surgery to the time of randomization. Patients may be on biphosphonates prior to study entry.
3. Prior isotope therapy (e.g., strontium, samarium, etc.), or whole pelvic irradiation, or prior radiotherapy to > 30% of bone marrow. Prior radiotherapy < 30% of bone marrow that is less than 4 weeks since the completion of radiation therapy. Or if the patient has not recovered from side effects of radiotherapy.
4. Adverse event (excluding alopecia and those listed in the specific exclusion criteria) from any prior anticancer therapy of grade >1(National Cancer Institute Common Terminology Criteria [NCI CTCAE] v3.0) at the time of randomization.
5. Prior treatment with VEGF inhibitors or VEGF receptor inhibitors.
6. Less than 18 years.
7. Eastern Cooperative Oncology Group (ECOG) performance status > 2.
8. History of brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
9. Prior malignancy. Adequately treated basal cell or squamous cell skin cancer are allowed, as well as any other cancer for which chemotherapy has been completed >5 years ago and from which the patient has been disease-free for > 5 years.
10. Participation in another clinical trial and any concurrent treatment with any investigational drug within 30 days prior to randomization.
11. Any of the following within 6 months prior to randomization: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, NYHA class III or IV congestive heart failure, cerebrovascular accident or transient ischemic attack.
12. Any of the following within 3 months prior to randomization: treatment-resistant peptic ulcer disease, erosive esophagitis or gastritis, infectious or inflammatory bowel disease, diverticulitis, pulmonary embolism, or other uncontrolled thromboembolic event.
13. Occurrence of deep vein thrombosis within 4 weeks prior to randomization.
14. Acquired immunodeficiency syndrome (AIDS-related illnesses) or known HIV disease requiring antiretroviral therapy.
15. Any severe acute or chronic medical condition which could impair the ability of the patient to participate to the study or interfere with interpretation of study results.
16. Absence of signed and dated Institutional Review Board (IRB)-approved patient informed consent form prior to enrollment into the study.
17. Patient with reproductive potential who do not agree to use accepted and effective method of contraception during the study treatment period and for at least 6 months after the completion of the study treatment. The definition of effective method of contraception” will be based on the investigator’s judgment.
For patients enrolled in the United Kingdom, their partner (unless surgically sterile, post menopausal or for another reason have no chance of becoming pregnant) should use an effective mean of contraception described hereafter: oral contraceptives or intra uterine device.

- Related to aflibercept:
18. Urine protein-creatinine ratio (UPCR) > 1 on morning spot urinalysis or proteinuria > 500 mg/24 hours.
19. Serum Creatinine > 1.5 x ULN. If creatinine 1.0 - 1.5 x ULN, creatinine clearance will be calculated either according to Cockcroft-Ga

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified