Docetaxel and Prednisone With or Without Bevacizumab in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00110214|
Recruitment Status : Completed
First Posted : May 5, 2005
Results First Posted : April 17, 2013
Last Update Posted : May 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Hormone-resistant Prostate Cancer Recurrent Prostate Cancer Stage IV Prostate Cancer||Drug: docetaxel Other: placebo Drug: prednisone Biological: bevacizumab Other: laboratory biomarker analysis||Phase 3|
I. To determine if the addition of bevacizumab to docetaxel and prednisone increases overall survival compared to docetaxel and prednisone alone in patients with HRPC.
I. To compare the progression-free survival of these two regimens in patients with HRPC.
II. To compare the two regimens on the proportion of patients who experience a 50% post-therapy PSA decline from baseline.
III. To compare the two regimens with respect to the proportion of patients who experience grade 3 or higher toxicities.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to predicted 24-month survival probability (< 10% vs 10-29.9% vs ≥ 30%), age (< 65 years vs ≥ 65 years), and prior history of arterial events (i.e., cardiac ischemia/infarction, CNS cerebrovascular ischemia, peripheral arterial ischemia, or CNS hemorrhage) (yes vs no). Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive docetaxel IV over 1 hour and placebo IV over 30-90 minutes on day 1. Patients also receive oral prednisone once daily on days 1-21.
ARM II: Patients receive docetaxel and prednisone as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1.
In both arms, courses repeat every 21 days for up to 2 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for up to 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1050 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||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|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||August 2011|
Experimental: Arm I
Patients receive docetaxel IV over 1 hour and placebo IV over 30-90 minutes on day 1. Patients also receive oral prednisone once daily on days 1-21.
Other Names:Other: placebo
Other Name: PLCBDrug: prednisone
Other Names:Other: laboratory biomarker analysis
Experimental: Arm II
Patients receive docetaxel and prednisone as in arm I. Patients also receive bevacizumab IV over 30-90 minutes on day 1.
Other Names:Drug: prednisone
Other Names:Biological: bevacizumab
Other Names:Other: laboratory biomarker analysis
- 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.
- Proportion of Participants Who Experienced at Least a 50% Post-therapy PSA (Prostate-Specific Antigen) Decline [ Time Frame: Duration of study (up to 5 years) ]PSA decline will be reported on all patients and will be defined as a decrease in PSA value by >= 50% for two successive evaluations at least 4 weeks apart. The reference PSA value for these declines should be measured within 2 weeks before starting therapy.
- Progression-free Survival (PFS) [ Time Frame: Duration of study (up to 5 years) ]
PFS was defined as the data of randomization to date of progression or death due to any cause, whichever occurs first. PFS was estimated using the Kaplan Meier method.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
- Proportion of Participants Who Experience (Maximum) Grade 3 or Higher Toxicities [ Time Frame: During treatment (up to 2 years) ]
The National Cancer Institute (NCI) Criteria for Adverse Events(CTCAE) Version 3.0 was used to evaluate toxicity. These events were considered at least possibly related to treatment.
Grade 1: mild; Grade 2: moderate; Grade 3: Severe; Grade 4: Life Threatening; Grade 5: Death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00110214
|United States, Connecticut|
|New Haven, Connecticut, United States, 06520|
|United States, Illinois|
|Cancer and Leukemia Group B|
|Chicago, Illinois, United States, 60606|
|Principal Investigator:||William Kelly||Cancer and Leukemia Group B|