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| Sponsor: | Barbara Ann Karmanos Cancer Institute |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00527124 |
Purpose
RATIONALE: 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. Cediranib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving docetaxel together with prednisone, with or without cediranib, may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving docetaxel and prednisone together with or without cediranib works in treating patients with metastatic prostate cancer that did not respond to hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Prostate Cancer |
Drug: cediranib maleate Drug: docetaxel Drug: prednisone |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
| Estimated Enrollment: | 104 |
| Study Start Date: | November 2007 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Drug: cediranib maleate
given orally
Drug: docetaxel
given IV
Drug: prednisone
given orally
|
|
Active Comparator: Arm II
Patients receive docetaxel and prednisone as in arm I.
|
Drug: docetaxel
given IV
Drug: prednisone
given orally
|
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified by participating institution. Patients are randomized to 1 of 2 treatment arms.
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the prostate
Clinical/radiologic metastases with objective evidence of disease progression by imaging or by rising prostate-specific antigen (PSA) despite androgen deprivation therapy
Meets 1 of the following criteria:
Measurable disease, with any level of PSA
Nonmeasurable disease
Castrate levels of testosterone < 50 ng/dL must be maintained and documented
No untreated unstable brain or meningeal metastases
PATIENT CHARACTERISTICS:
Inclusion criteria:
Exclusion criteria:
Uncontrolled intercurrent illness including, but not limited to, any of the following:
New York Heart Association class III or IV cardiac disease
PRIOR CONCURRENT THERAPY:
Contacts and Locations| United States, California | |
| UC Davis Cancer Center | |
| Sacramento, California, United States, 95817 | |
| United States, Colorado | |
| University of Colorado at Denver and Health Sciences Center | |
| Aurora, Colorado, United States, 80045-0511 | |
| United States, Maryland | |
| Greenebaum Cancer Center at University of Maryland Medical Center | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Michigan | |
| St. Joseph Mercy Health System- Ann Arbor | |
| Ann Arbor, Michigan, United States, 48106 | |
| Barbara Ann Karmanos Cancer Institute | |
| Detroit, Michigan, United States, 48201-1379 | |
| Veterans Affairs Medical Center - Detroit | |
| Detroit, Michigan, United States, 48201 | |
| United States, Ohio | |
| Arthur G. James Cancer Hospital and Richard Solove Research Institute/ Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | |
| Houston, Texas, United States, 77030-4009 | |
| United States, Wisconsin | |
| University of Wisconsin-Paul P. Carbone Comprehensive Cancer Center | |
| Madison, Wisconsin, United States, 53792 | |
| Study Chair: | Elisabeth I. Heath, MD | Barbara Ann Karmanos Cancer Institute |
More Information
| Responsible Party: | Patricia M. LoRusso, Barbara Ann Karmanos Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00527124 History of Changes |
| Other Study ID Numbers: | CDR0000564449, U01CA062487, P30CA022453, WSU-2007-015 |
| Study First Received: | September 7, 2007 |
| Last Updated: | January 23, 2012 |
| Health Authority: | United States: Food and Drug Administration |
|
stage IV prostate cancer adenocarcinoma of the prostate |
|
Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Prednisone Docetaxel |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |