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| Study 2 of 7 for search of: | atrasentan prostate cancer |
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| Sponsor: | Southwest Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00134056 |
Purpose
RATIONALE: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer.
PURPOSE: This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Metastatic Cancer Prostate Cancer |
Drug: atrasentan hydrochloride Drug: docetaxel Drug: prednisone Other: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
| Official Title: | Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer |
| Estimated Enrollment: | 930 |
| Study Start Date: | August 2006 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm I: Experimental
Patients receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. Treatment repeats every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks.
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Drug: atrasentan hydrochloride
Given orally
Drug: docetaxel
Docetaxel given IV and prednisone given orally
Drug: prednisone
Docetaxel given IV and prednisone given orally
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Arm II: Active Comparator
Patients receive docetaxel and prednisone as in arm I. Patients also receive oral placebo once daily on days 1-21. Treatment repeat every 21 days for up to 12 courses. Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks.
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Drug: docetaxel
Docetaxel given IV and prednisone given orally
Drug: prednisone
Docetaxel given IV and prednisone given orally
Other: placebo
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to disease progression (measurable or non-measurable disease progression vs prostate-specific antigen progression only), use of bisphosphonates at study entry (yes vs no), worst pain, measured by the Brief Pain Inventory "pain" scale (< grade 4 vs ≥ grade 4), and extraskeletal metastases (yes vs no). Patients are randomized to 1 of 2 treatment arms.
NOTE: *Patients with PSA progression alone will be allowed to continue treatment
Quality of life is assessed at baseline, before courses 4, 7, and 10, and then after completion of study treatment.
After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 years from study entry.
PROJECTED ACCRUAL: A total of 930 patients will be accrued for this study within 4 years.
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
Stage IV disease (any T, any N, M1b)
Measurable or nonmeasurable disease
Hormone-refractory disease despite androgen deprivation and antiandrogen withdrawal, as defined by 1 of the following criteria:
Prostate-specific antigen (PSA) progression, defined as 3 consecutive rising PSA levels* taken ≥ 1 week apart
Must have undergone surgical or medical (e.g., luteinizing hormone-releasing hormone [LHRH] agonist [e.g., leuprolide or goserelin] or LHRH antagonist therapy) castration
No prior or concurrent brain metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
No more than 1 prior systemic vaccine or biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Concurrent bisphosphonates allowed provided therapy is started prior to study entry, dose is maintained during the first 12 weeks of study treatment, and patient meets criteria for disease progression
No concurrent herbal medications or food supplements (e.g., PC-SPES, saw palmetto, Hypericum perforatum [St. John's wort])
At least 14 days since prior and no concurrent administration of any of the following:
Contacts and Locations
Show 539 Study Locations| Study Chair: | David I. Quinn, MD | USC/Norris Comprehensive Cancer Center |
| Investigator: | Maha Hadi A. Hussain, MD | University of Michigan Cancer Center |
| Investigator: | Primo N. Lara, MD | University of California, Davis |
| Investigator: | Mark Garzotto, MD | Department of Veterans Affairs |
More Information
| Responsible Party: | Southwest Oncology Group - Group Chair's Office ( Laurence H. Baker ) |
| Study ID Numbers: | CDR0000439434, SWOG-S0421 |
| Study First Received: | August 22, 2005 |
| Last Updated: | February 6, 2010 |
| ClinicalTrials.gov Identifier: | NCT00134056 History of Changes |
| Health Authority: | Unspecified |
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adenocarcinoma of the prostate stage IV prostate cancer recurrent prostate cancer bone metastases |
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Prostatic Diseases Genital Neoplasms, Male Neoplasm Metastasis Urogenital Neoplasms Neoplasms by Site Prostatic Neoplasms Neoplasms Anti-Inflammatory Agents Prednisone Antineoplastic Agents, Hormonal Antineoplastic Agents |
Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Genital Diseases, Male Hormones Glucocorticoids Pharmacologic Actions Docetaxel Neoplastic Processes Pathologic Processes Therapeutic Uses |