Trial Information

Summary: CALGB 90401: A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Docetaxel and Prednisone With or Without Bevacizumab in Men With Hormone Refractory Prostate Cancer

Condition: Adenocarcinoma of the prostate with progressive systemic disease after treatment with hormone therapy.

Eligible patients will be randomized to receive either Decadron (oral), Docetaxel (IV), Placebo(IV) and Prednisone(oral) OR Decadron(oral), Docetaxel(IV), Bevacizumab(IV) and Prednisone(oral) every 3 weeks until disease progression or unacceptable toxicity (or for a maximum of 2 years.)

Patient Inclusion Criteria:

• Evidence of progressive metastatic disease by:
  • Measurable disease w/any level of serum PSA, or
  • Non-measurable disease w/PSA > 5ng/ml.

• Flutamide and megestrol acetate must be discontinued > 4 wks before registration (> 6 wks pre-regist for bicalutamide and nilutamide).
• Primary testicular androgen suppression (e.g., w/LHRH agonist) should not be discontinued.
• > 4 wks since any other hormonal therapy, including ketoconazole, aminoglutethimide, systemic steroids (any dose), or megestrol acetate .
• No prior cytotoxic chemo, including estramustine or suramin.
• No prior anti-angiogenesis agents, including thalidomide and bevacizumab.
• No known brain mets. No current CHF.
• Any hypertension, must be well-controlled (< 160/90) on anti-hypertensive therapy.
• Pts on full-dose anticoagulants must be on a stable dose of warfarin and have in-range INR (usually 2-3) or be on stable dose of LMW heparin.
• Anti-platelet agents, daily prophylactic aspirin, or anticoagulation for atrial fib are allowed.
• No significant hx of bleeding episodes w/I 6 mos pre-regist or GI perforation w/I 12 mos pre- regist.
• No cardiovascular events w/I past 6 mos.
• No serious or non-healing wound, ulcer, or bone fracture.

Intervention Type: Drug

If you would like to learn more about participating in this study, please send an e-mail message using the form below.