Docetaxel and Prednisone With or Without Cediranib in Treating Patients With Metastatic Prostate Cancer That Did Not Respond to Hormone Therapy
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|ClinicalTrials.gov Identifier: NCT00527124|
Recruitment Status : Terminated (Closure was recommended by CTEP due to slow accrual.)
First Posted : September 10, 2007
Results First Posted : March 11, 2014
Last Update Posted : August 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Stage IV Prostate Cancer||Drug: cediranib maleate Drug: docetaxel Drug: prednisone Other: laboratory biomarker analysis||Phase 2|
I. To determine the 6-month progression-free survival rate of patients with hormone refractory metastatic adenocarcinoma of the prostate treated with docetaxel and prednisone with vs without cediranib.
I. To evaluate the safety profile of cediranib, docetaxel, and prednisone in patients with metastatic hormone-refractory prostate cancer.
II. To determine the duration of prostate-specific antigen (PSA) response and PSA control in patients with metastatic hormone-refractory prostate cancer treated with cediranib, docetaxel, and prednisone.
III. To determine the partial and complete response rate in patients with measurable disease treated with cediranib, docetaxel, and prednisone.
IV. To determine time to progression in patients with metastatic hormone-refractory prostate cancer treated with cediranib, docetaxel, and prednisone.
V. To determine overall survival in patients with metastatic hormone-refractory prostate cancer.
VI. To perform correlative marker studies measuring serum levels of VEGF, PDGF, sICAM, bFGF, interleukin (IL)-6, and IL-8.
VII. To perform a pilot study of [F18]FMAU positron emission test (PET) imaging on patients receiving cediranib, docetaxel, and prednisone.
OUTLINE: This is a multicenter study. Patients are stratified by participating institution. Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
ARM II: Patients receive docetaxel and prednisone as in arm I.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Archival paraffin-embedded tissue blocks or slides from time of diagnosis (or subsequent, but prior to therapy) are evaluated for expression of molecular targets relevant to this study. Blood specimens from baseline, after courses 1 and 2, and after completion of study treatment are analyzed for protein markers. Samples are analyzed by ELISA and IHC for angiogenesis-associated plasma proteins, plasma levels of VEGF, tumor expression of PDGFR, and interleukin (IL)-6 and IL-8 plasma levels. Patients also undergo positron emission test (PET) scans utilizing fluorodeoxyglucose (FDG) at baseline and after course 1.
After completion of study treatment, patients are followed every 3 months for 52 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized, Phase II Trial of AZD2171, Docetaxel, and Prednisone Compared to Docetaxel and Prednisone in Patients With Metastatic, Hormone Refractory Prostate Cancer|
|Study Start Date :||November 2007|
|Actual Primary Completion Date :||July 2012|
|Actual Study Completion Date :||November 2013|
Experimental: Arm I
Patients receive oral cediranib maleate once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
Drug: cediranib maleate
Other: laboratory biomarker analysis
Active Comparator: Arm II
Patients receive docetaxel and prednisone as in arm I.
Other: laboratory biomarker analysis
- 6-month Progression-free Survival (PFS) Proportion [ Time Frame: Followed for 52 weeks at 3 month intervals after coming off treatment, time period equal to the length of treatment + up to 12 months ]The proportion of patients on each treatment arm who survive ≥ 6.00 months progression-free
- Prostate-specific Antigen (PSA) Response in Accordance With the Prostate Specific Antigen Working Group [ Time Frame: Up to 52 weeks ]PSA < 4.0 ng/ml. is a CR. A 50% decline or better in PSA is a PR. Less than a 50% decline in PSA and less than a 25% increase in PSA is SD. A 25% or greater increase in PSA level by at least 5 ng/mL is PD by PSA only. The point estimate and 95% Wilson CI estimates of the proportion for the Prostate-specific antigen (PSA) response will be computed .
- Overall Response Rate Evaluated by the RECIST Criteria [ Time Frame: Up to 52 weeks ]
The overall response is determined by combining the patient's status on target lesions, PSA, non-target lesions, and new disease as defined in the following table.
Target Lesions CR CR PR SD PD Any Any Any
PSA Response CR PR PR Non-PD Any Any PD Any
Non-Target Lesions CR Non-CR/Non-PD Non-PD Non-PD Any PD Any Any
New Lesions No No No No Yes or No Yes or No Yes or No Yes
Overall Response CR PR PR SD PD PD PD PD
- Time to Progression [ Time Frame: The time from registration date until documented clinical disease progression, or until date of death, whichever occurs first, assessed up to 52 weeks ]Analyzed with standard K-M methodology. Both point and 95% CI estimates of the median and other statistics (e.g., the 3-month rate, 6-month rate, etc.) will be computed from the censored distribution of TTP. These point and CI estimates will be reported for all patients combined, and separately for each treatment arm.
- Overall Survival [ Time Frame: The time from registration date until death from any cause, assessed up to 52 weeks ]Analyzed with standard K-M methodology. A 12 month survival rate will be calculated since median survival was not reached by the end of the study period.
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): NCT00527124
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Wayne State University|
|Detroit, Michigan, United States, 48202|
|United States, Texas|
|M D Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Wisconsin|
|University of Wisconsin Hospital and Clinics|
|Madison, Wisconsin, United States, 53792|
|Principal Investigator:||Elisabeth Heath||Wayne State University|