Mitoxantrone and Prednisone With or Without Leflunomide in Treating Patients With Stage IV Prostate Cancer

NCT00004071

Last updated date
Study Location
Comprehensive Cancer Care Specialists of Boca Raton
Boca Raton, Florida, 33428, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Prostate Cancer
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Prostate CancerMitoxantrone and Prednisone With or Without Leflunomide in Treating Patients With Stage IV Prostate Cancer NCT00004071
  1. Boca Raton, Florida
  2. Fort Myers, Florida
  3. New York, New York
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerChemotherapy in Treating Patients Who Have Metastatic Prostate Cancer NCT00003343
  1. La Jolla, California
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerStudy of Enzalutamide (Formerly MDV3100) as a Neoadjuvant Therapy for Patients Undergoing Prostatectomy for Localized Prostate Cancer NCT01547299
  1. Boston, Massachusetts
  2. Seattle, Washington
  3. Vancouver, British Columbia
  4. Toronto, Ontario
Male
18 Years+
years
MULTIPLE SITES
Prostate CancerA Safety and Efficacy Study of Oral MDV3100 in Chemotherapy-Naive Patients With Progressive Metastatic Prostate Cancer NCT01212991
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Tucson, Arizona
  4. Tucson, Arizona
  5. La Mesa, California
  6. Los Angeles, California
  7. Los Angeles, California
  8. Los Angeles, California
  9. Los Angeles, California
  10. Los Angeles, California
  11. Los Angeles, California
  12. Oceanside, California
  13. Sacramento, California
  14. Sacramento, California
  15. San Diego, California
  16. San Diego, California
  17. San Diego, California
  18. Stanford, California
  19. Aurora, Colorado
  20. Aurora, Colorado
  21. Boca Raton, Florida
  22. Chicago, Illinois
  23. Chicago, Illinois
  24. Louisville, Kentucky
  25. Boston, Massachusetts
  26. Boston, Massachusetts
  27. Boston, Massachusetts
  28. Detroit, Michigan
  29. Farmington Hills, Michigan
  30. Rochester, Minnesota
  31. Creve Coeur, Missouri
  32. Saint Louis, Missouri
  33. Saint Louis, Missouri
  34. Saint Louis, Missouri
  35. Saint Peters, Missouri
  36. Omaha, Nebraska
  37. New York, New York
  38. New York, New York
  39. Cary, North Carolina
  40. Charlotte, North Carolina
  41. Charlotte, North Carolina
  42. Charlotte, North Carolina
  43. Charlotte, North Carolina
  44. Charlotte, North Carolina
  45. Durham, North Carolina
  46. Durham, North Carolina
  47. Raleigh, North Carolina
  48. Portland, Oregon
  49. Philadelphia, Pennsylvania
  50. Pittsburgh, Pennsylvania
  51. Pittsburgh, Pennsylvania
  52. Charleston, South Carolina
  53. Charleston, South Carolina
  54. Charleston, South Carolina
  55. Charleston, South Carolina
  56. Mount Pleasant, South Carolina
  57. Mount Pleasant, South Carolina
  58. Dallas, Texas
  59. Hampton, Virginia
  60. Newport News, Virginia
  61. Norfolk, Virginia
  62. Virginia Beach, Virginia
  63. Seattle, Washington
  64. Seattle, Washington
  65. Madison, Wisconsin
  66. Concord, New South Wales
  67. Kogarah, New South Wales
  68. Lismore, New South Wales
  69. Liverpool, New South Wales
  70. Port Macquarie, New South Wales
  71. Randwick, New South Wales
  72. St Leonards, New South Wales
  73. Sydney, New South Wales
  74. Wahroonga, New South Wales
  75. Wahroonga, New South Wales
  76. Wahroonga, New South Wales
  77. Waratah, New South Wales
  78. Westmead, New South Wales
  79. Auchenflower, Queensland
  80. Auchenflower, Queensland
  81. Auchenflower, Queensland
  82. Chermside, Queensland
  83. Herston, Queensland
  84. Herston, Queensland
  85. South Brisbane, Queensland
  86. South Brisbane, Queensland
  87. South Brisbane, Queensland
  88. Kurralta Park, South Australia
  89. Kurralta Park, South Australia
  90. Kurralta park, South Australia
  91. Kurralta Park, South Australia
  92. Bendigo, Victoria
  93. Bendigo, Victoria
  94. Box Hill, Victoria
  95. Box Hill, Victoria
  96. Box Hill, Victoria
  97. Box Hill, Victoria
  98. Brighton, Victoria
  99. Clayton, Victoria
  100. East Melbourne, Victoria
  101. Geelong, Victoria
  102. Heidelberg, Victoria
  103. Malvern,, Victoria
  104. Malvern, Victoria
  105. Malvern, Victoria
  106. Melbourne, Victoria
  107. St Albans, Victoria
  108. Linz,
  109. Salzburg,
  110. Salzburg,
  111. Wien,
  112. Brussels,
  113. Ghent,
  114. Hasselt,
  115. Kortrijk,
  116. Leuven,
  117. Liege,
  118. Calgary, Alberta
  119. Calgary, Alberta
  120. Edmonton, Alberta
  121. Kelowna, British Columbia
  122. Vancouver, British Columbia
  123. Victoria, British Columbia
  124. Victoria, British Columbia
  125. Winnipeg, Manitoba
  126. Halifax, Nova Scotia
  127. Halifax, Nova Scotia
  128. Halifax, Nova Scotia
  129. Hamilton, Ontario
  130. London, Ontario
  131. Ottawa, Ontario
  132. Ottawa, Ontario
  133. Toronto, Ontario
  134. Toronto, Ontario
  135. Montreal, Quebec
  136. Quebec,
  137. Quebec,
  138. Aalborg,
  139. Aarhus N,
  140. Copenhagen,
  141. Frederiksberg,
  142. Herlev,
  143. Roskilde,
  144. Helsinki,
  145. Helsinki,
  146. Oulu,
  147. Tampere,
  148. Strasbourg, Alsace
  149. Rennes cedex, Bretagne
  150. Bordeaux, Nouvelle Aquitaine
  151. Angers,
  152. Avignon,
  153. Bordeaux,
  154. La Roche sur Yon Cedex,
  155. Le Mans,
  156. Lyon,
  157. Paris Cedex 15,
  158. Paris,
  159. Paris,
  160. Saint Herblain Cedex,
  161. Saint-Mande,
  162. Saint-Priest en Jarez,
  163. Toulouse,
  164. Villejuif,
  165. Hannover, Niedersachsen
  166. Berlin,
  167. Braunschweig,
  168. Dresden,
  169. Hamburg,
  170. Hamburg,
  171. Heidelberg,
  172. Homburg/Saar,
  173. Mannheim,
  174. Muenster,
  175. Tuebingen,
  176. Ulm,
  177. Weiden In Der Oberpfalz,
  178. Beer Sheva,
  179. Beer Yaakov,
  180. Haifa,
  181. Petach Tikva,
  182. Ramat Gan,
  183. Cremona, CR
  184. Meldola, FC
  185. Orbassano, TO
  186. Arezzo,
  187. Forli,
  188. Rome,
  189. Fukuoka-shi, Fukuoka
  190. Yokohama-shi, Kanagawa-ken
  191. Sendai-Shi, Miyagi
  192. Nagasaki-shi, Nagasaki
  193. Osaka-sayama, Osaka
  194. Osaka-shi, Osaka
  195. Suita-shi, Osaka
  196. Tokushima-shi, Tokushima
  197. Bunkyo-ku, Tokyo
  198. Itabashi-ku, Tokyo
  199. Koutou-ku, Tokyo
  200. Mitaka-shi, Tokyo
  201. Shinagawa-ku, Tokyo
  202. Shinjyuku-ku, Tokyo
  203. Ube-shi, Yamaguchi
  204. Chiba,
  205. Kyoto,
  206. Niigata,
  207. Osaka,
  208. Tokyo,
  209. Yamagata,
  210. Goyang, Gyeonggi-do
  211. Seongnam-si, Gyeonggi-do
  212. Hwasun-eup, Hwasun-gun, Jeonnam
  213. Gangnam-gu, Seoul
  214. Songpa-gu, Seoul
  215. Seoul,
  216. Seoul,
  217. Klaipeda,
  218. Vilnius,
  219. Amsterdam,
  220. Eindhoven,
  221. Groningen,
  222. Nijmegen,
  223. Wroclaw, Dolnoslaskie
  224. Lodz, Lodzkie
  225. Gdansk, Pomorskie
  226. Gdansk, Pomorskie
  227. Myslowice, Slaskie
  228. Poznan, Wielkopolskie
  229. Moscow,
  230. St-Petersburg,
  231. St-Petersburg,
  232. St.-Petersburg,
  233. Singapore,
  234. Singapore,
  235. Banska Bystrica,
  236. Bratislava,
  237. Martin,
  238. Nitra,
  239. Presov,
  240. Presov,
  241. Badalona, Barcelona
  242. Manresa, Barcelona
  243. Palma de Mallorca, Islas Baleares
  244. Pamplona, Navarra
  245. A Coruna,
  246. Barcelona,
  247. Barcelona,
  248. Barcelona,
  249. Madrid,
  250. Madrid,
  251. Sabadell(Barcelona),
  252. Gothenburg,
  253. Malmo,
  254. Orebro,
  255. Stockholm,
  256. Umea,
  257. Northwood, Middlesex
  258. Northwood, Middlesex
  259. Oxford, Oxfordshire
  260. Sutton, Surrey
  261. Newcastle Upon Tyne, Tyne and Wear
  262. Cardiff, Wales
  263. Bebington, Wirral, Merseyside
  264. Brighton, East Sussex,
  265. Bristol,
  266. Edinburgh,
  267. London,
  268. London,
  269. London,
Male
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Mitoxantrone and Prednisone With or Without Leflunomide in Treating Patients With Stage IV Prostate Cancer
Official Title  ICMJE A Randomized, Open-Label Phase II/III Study of SU101 Plus Mitoxantrone/Prednisone Compared to Mitoxantrone/Prednisone Alone in Patients With Hormone-Refractory Prostate Cancer
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known if mitoxantrone and prednisone are more effective with or without leflunomide for treating prostate cancer.

PURPOSE: Randomized phase II/III trial to compare the effectiveness of mitoxantrone and prednisone with or without leflunomide in treating patients who have stage IV prostate cancer that has not responded to hormone therapy.

Detailed Description

OBJECTIVES: I. Compare the percentage one year survival rate in hormone refractory prostate cancer patients treated with leflunomide (SU101), mitoxantrone, and prednisone versus mitoxantrone and prednisone alone. II. Compare the palliative pain response, time to treatment failure, time to progression, median survival, investigator global response assessment, objective response, time to palliative pain response, duration of palliation, and effect on PSA between these two regimens. III. Assess the safety and tolerability of mitoxantrone in combination with SU101 in these patients. IV. Assess the health related quality of life of these patients on these regimens.

OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified by performance status (70-80% vs 90-100%), baseline present pain intensity score (2.0 vs greater than 2.0), and hemoglobin level (less than 12.0 g/dL vs at least 12.0 g/dL). Patients enter one of two treatment arms: Arm I: Patients are premedicated with an IV 5-HT3 reuptake inhibitor (i.e., odansetron) then receive mitoxantrone IV on day 1. Twice daily oral prednisone therapy begins on day 1 and continues throughout study treatment. Treatment repeats every 21 days for 4 courses. Arm II: Patients are premedicated with an IV 5-HT3 reuptake inhibitor as in arm I. Patients receive mitoxantrone and prednisone therapy as in arm I. Additionally, beginning on day 1 patients receive leflunomide (SU101) IV over 4-5 hours weekly for 12 weeks. The SU101 infusions shall precede mitoxantrone infusions. Patients receive a maximum of one year therapy with SU101; mitoxantrone therapy may be administered up to a maximum dose of 140/m2. Quality of life is assessed at baseline, day 8, day 21, and then every 3 weeks thereafter until study completion. Patients are followed at least every 2 months.

PROJECTED ACCRUAL: Up to 370 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Primary Purpose: Treatment
Condition  ICMJE Prostate Cancer
Intervention  ICMJE
  • Drug: leflunomide
  • Drug: mitoxantrone hydrochloride
  • Drug: prednisone
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE September 2007
Actual Primary Completion Date September 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS: Histologically proven hormone refractory stage IV prostate cancer Hormone refractory disease is defined as: Progressive measurable disease OR Progressive disease by bone scan OR Increase in PSA by 50% over nadir level confirmed twice and measured at least two weeks apart Prior treatment with primary androgen ablative therapy with castrate levels of testosterone Minimum score of 2 on the McGill 6 point pain scale secondary to metastatic bony pain with an analgesic score of at least 4 No CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Greater than 16 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 8.0 g/dL (without blood transfusion(s) within 2 weeks prior to study) Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) AST no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: No cardiac failure No myocardial infarction within the past 6 months No uncontrolled hypertension LVEF greater than 50% Other: Fertile patients must use effective barrier contraception during and for 3 months after study No known hypersensitivity to polysorbate or polyethylene glycol No other malignancies within past 5 years, except basal cell skin cancer No other acute or chronic medical, psychiatric, or lab abnormality that would prevent compliance No uncontrolled peptic ulcer No active infection No contraindication to mitoxantrone therapy No contraindication to prednisone therapy

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic response modifiers At least 4 weeks since prior immunotherapy No concurrent immunotherapy Chemotherapy: No prior SU101 or mitoxantrone No prior cytotoxic chemotherapy for prostate cancer No other concurrent chemotherapy Endocrine therapy: See Disease Characteristics At least 4 weeks since prior antiandrogen therapy and recovered Concurrent primary androgen ablation therapy (orchidectomy, luteinizing hormone releasing hormone (LHRH) agonist (if stable dose), estrogen, or cyproterone acetate) allowed No concurrent antiandrogen therapy (except LHRH) No concurrent cholestyramine Radiotherapy: At least 4 weeks since prior radiotherapy (8 weeks since strontium 89 and samarium 153) Prior palliative radiotherapy to metastatic sites allowed No prior radiotherapy to greater than 50% of bone marrow No concurrent radiotherapy except for palliation of bone pain Surgery: At least 2 weeks since prior major surgery No concurrent surgery for prostate cancer Other: At least 4 weeks since prior investigational therapy At least 4 weeks since prior antiangiogenesis therapy At least 6 weeks since prior bicalutamide No other concurrent investigational therapy

Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00004071
Other Study ID Numbers  ICMJE SUGEN-SU101.035
CDR0000067275
SUGEN-990711
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair:Mack H. Mabry, MDSUGEN
PRS Account Pfizer
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP