NCT00110214

A Randomized Double-Blinded Placebo Controlled Phase III Trial Comparing Doctaxel and Prednisone With and Without Bevacizumab (IND #7921, NSC #704865) in Men With Hormone Refractory Prostate Cancer

Completed Phase 3 Results posted Last updated 21 April 2014

What this trial tests

Phase 3 trial testing docetaxel in Adenocarcinoma of the Prostate in 1,050 participants. Completed in 1 August 2011.

Timeline

1 April 2005

Primary endpoint
1 March 2010

1 August 2011

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	1,050
Start date	1 April 2005
Primary completion	1 March 2010
Estimated completion	1 August 2011
Sites	2 locations across United States

Drugs / interventions tested

• docetaxel (Docetaxel) — full drug profile →
• placebo
• prednisone (prednisone) — full drug profile →
• bevacizumab (Bevacizumab-Bvzr) — full drug profile →
• laboratory biomarker analysis

Conditions studied

• Adenocarcinoma of the Prostate — all drugs for Adenocarcinoma of the Prostate →
• Hormone-resistant Prostate Cancer — all drugs for Hormone-resistant Prostate Cancer →
• Recurrent Prostate Cancer — all drugs for Recurrent Prostate Cancer →
• Stage IV Prostate Cancer — all drugs for Stage IV Prostate Cancer →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, male only, with Adenocarcinoma of the Prostate or Hormone-resistant Prostate Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Overall Survival
  Time frame: Duration of study (up to 5 years)
  Overall Survival (OS) was measured from the date of randomization to date of death due to any cause. OS was estimated using the Kaplan Meier method.

Sponsor's own description

This randomized phase III trial is studying docetaxel, prednisone, and bevacizumab to see how well they work compared to docetaxel and prednisone in treating patients with prostate cancer that did not respond to hormone therapy. Drugs used in chemotherapy, such as docetaxel and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether docetaxel, prednisone, and bevacizumab are more effective than docetaxel and prednisone in treating prostate cancer.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Prostate Cancer Review: Genetics, Diagnosis, Treatment Options, and Alternative Approaches.
   Sekhoacha M, Riet K, Motloung P, Gumenku L, et al · · 2022 · cited 539× · PMID 36080493 · DOI 10.3390/molecules27175730
2. Randomized, double-blind, placebo-controlled phase III trial comparing docetaxel and prednisone with or without bevacizumab in men with metastatic castration-resistant prostate cancer: CALGB 90401.
   Kelly WK, Halabi S, Carducci M, George D, et al · · 2012 · cited 384× · PMID 22454414 · DOI 10.1200/jco.2011.39.4767
3. Targeting signaling pathways in prostate cancer: mechanisms and clinical trials.
   He Y, Xu W, Xiao YT, Huang H, et al · · 2022 · cited 192× · PMID 35750683 · DOI 10.1038/s41392-022-01042-7
4. Overall Survival of Black and White Men With Metastatic Castration-Resistant Prostate Cancer Treated With Docetaxel.
   Halabi S, Dutta S, Tangen CM, Rosenthal M, et al · · 2019 · cited 101× · PMID 30576268 · DOI 10.1200/jco.18.01279
5. Novel therapies for metastatic castrate-resistant prostate cancer.
   Dayyani F, Gallick GE, Logothetis CJ, Corn PG. · · 2011 · cited 88× · PMID 21917607 · DOI 10.1093/jnci/djr362
6. Overcoming drug resistance and treating advanced prostate cancer.
   Semenas J, Allegrucci C, Boorjian SA, Mongan NP, et al · · 2012 · cited 78× · PMID 22746994 · DOI 10.2174/138945012802429615
7. Novel targeted therapeutics for metastatic castration-resistant prostate cancer.
   Antonarakis ES, Carducci MA, Eisenberger MA. · · 2010 · cited 58× · PMID 19717225 · DOI 10.1016/j.canlet.2009.08.012
8. Phase III trials with docetaxel-based combinations for metastatic castration-resistant prostate cancer: time to learn from past experiences.
   Antonarakis ES, Eisenberger MA. · · 2013 · cited 49× · PMID 23569320 · DOI 10.1200/jco.2013.48.8825