Study Summary
This trial is testing a new cancer treatment combining two drugs, to see what the maximum safe dose is, and what side effects may occur. A total of 18-43 people will take part across four US centers.
Eligible Conditions
- Metastatic Castration Resistant Prostate Cancer
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 8 Secondary · Reporting Duration: Up to 25 years
Year 25
Efficacy, assessed as non-progression/progression rate according to prostate cancer working group (PCWG2) criteria
Response to treatment, as assessed by prostate-specific antigen (PSA) Kinetics and Objective Responses
Satisfaction, as assessed by Quality of Life Questionnaires
Up to 25 years
Overall Survival
Progression Free Survival (PFS)
Time to Treatment Failure (TTTF)
Up to 28 weeks
Proportion of Randomized Subjects to Complete Combination Therapy on Schedule per Protocol
Response to Treatment, as assessed by Bone Bio-marker Outcomes
Up to 29 Days
Incidence of Dose Limiting Toxicities (DLT)
Trial Safety
Safety Progress
Side Effects for
Trastuzumab
59%Leukopenia
56%Neutropenia
34%Hypoaesthesia
31%Agranulocytosis
22%Alopecia
22%Asthenia
19%Pyrexia
16%Nail disorder
16%Oedema peripheral
16%Diarrhoea
16%Hypophagia
13%Alanine aminotransferase increased
13%Neurotoxicity
13%Cough
13%Vomting
9%Aspartate aminotransferase increased
9%Headache
9%Musculoskeletal pain
9%Chest discomfort
9%Rash
9%Pigmentation disorder
9%Nausea
9%Bone marrow failure
9%Anaemia
6%Transaminases increased
6%Insomnia
6%Nasopharyngitis
6%Paronychia
6%Flushing
6%Face oedema
6%Constipation
6%Mouth ulceration
6%Thrombocytopenia
3%Cataract
3%Infection
3%Upper respiratory tract infection
3%Completed suicide
Trial Design
2 Treatment Groups
Dose expansion
1 of 2
Dose escalation
1 of 2
Experimental Treatment
25 Total Participants · 2 Treatment Groups
Primary Treatment: Docetaxel · No Placebo Group · Phase 1
Dose expansionExperimental Group · 2 Interventions: Radium 223, Docetaxel · Intervention Types: Radiation, Drug
Dose escalationExperimental Group · 2 Interventions: Radium 223, Docetaxel · Intervention Types: Radiation, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Radium 223
2014
Completed Phase 2
~20
Docetaxel
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 25 years
Who is running the clinical trial?
Ohio State University Comprehensive Cancer CenterOTHER
290 Previous Clinical Trials
286,114 Total Patients Enrolled
10 Trials studying Prostate Cancer
4,639 Patients Enrolled for Prostate Cancer
Henry Ford HospitalOTHER
23 Previous Clinical Trials
6,076 Total Patients Enrolled
Lahey ClinicOTHER
70 Previous Clinical Trials
245,013 Total Patients Enrolled
2 Trials studying Prostate Cancer
5,052 Patients Enrolled for Prostate Cancer
BayerIndustry Sponsor
2,159 Previous Clinical Trials
23,877,513 Total Patients Enrolled
36 Trials studying Prostate Cancer
25,162 Patients Enrolled for Prostate Cancer
Tufts Medical CenterLead Sponsor
240 Previous Clinical Trials
245,236 Total Patients Enrolled
Paul Mathew, MDPrincipal InvestigatorTufts Medical Center
4 Previous Clinical Trials
74 Total Patients Enrolled
3 Trials studying Prostate Cancer
57 Patients Enrolled for Prostate Cancer
Eligibility Criteria
Age 18+ · All Participants · 16 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Rewritten criterion: You are able to receive docetaxel chemotherapy as a treatment option.
References
- Beer, Tomasz M., Andrew J. Armstrong, Dana E. Rathkopf, Yohann Loriot, Cora N. Sternberg, Celestia S. Higano, Peter Iversen, et al.. 2014. “Enzalutamide in Metastatic Prostate Cancer Before Chemotherapy”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1405095.
- Antonarakis, Emmanuel S., Changxue Lu, Brandon Luber, Hao Wang, Yan Chen, Mary Nakazawa, Rosa Nadal, et al.. 2015. “Androgen Receptor Splice Variant 7 and Efficacy of Taxane Chemotherapy in Patients with Metastatic Castration-resistant Prostate Cancer”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2015.1341.
- Kellokumpu-Lehtinen, Pirkko-Liisa, Ulrika Harmenberg, Timo Joensuu, Ray McDermott, Petteri Hervonen, Claes Ginman, Marjaana Luukkaa, et al.. 2013. “2-weekly Versus 3-weekly Docetaxel to Treat Castration-resistant Advanced Prostate Cancer: A Randomised, Phase 3 Trial”. The Lancet Oncology. Elsevier BV. doi:10.1016/s1470-2045(12)70537-5.
- Oudard, Stéphane, Eugeniu Banu, Philippe Beuzeboc, Eric Voog, Louis Marie Dourthe, Anne Claire Hardy-Bessard, Claude Linassier, et al.. 2005. “Multicenter Randomized Phase II Study of Two Schedules of Docetaxel, Estramustine, and Prednisone Versus Mitoxantrone Plus Prednisone in Patients with Metastatic Hormone-refractory Prostate Cancer”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2005.12.187.
- Kantoff, Philip W., Celestia S. Higano, Neal D. Shore, E. Roy Berger, Eric J. Small, David F. Penson, Charles H. Redfern, et al.. 2010. “Sipuleucel-t Immunotherapy for Castration-resistant Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1001294.
- Petrylak, Daniel P., Catherine M. Tangen, Maha H.A. Hussain, Primo N. Lara Jr., Jeffrey A. Jones, Mary Ellen Taplin, Patrick A. Burch, et al.. 2004. “Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone for Advanced Refractory Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa041318.
- Ryan, Charles J., Matthew R. Smith, Johann S. de Bono, Arturo Molina, Christopher J. Logothetis, Paul de Souza, Karim Fizazi, et al.. 2013. “Abiraterone in Metastatic Prostate Cancer Without Previous Chemotherapy”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1209096.
- Scher, Howard I., Susan Halabi, Ian Tannock, Michael Morris, Cora N. Sternberg, Michael A. Carducci, Mario A. Eisenberger, et al.. 2008. “Design and End Points of Clinical Trials for Patients with Progressive Prostate Cancer and Castrate Levels of Testosterone: Recommendations of the Prostate Cancer Clinical Trials Working Group”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.2007.12.4487.
- Antonarakis, Emmanuel S., Changxue Lu, Hao Wang, Brandon Luber, Mary Nakazawa, Jeffrey C. Roeser, Yan Chen, et al.. 2014. “AR-V7 and Resistance to Enzalutamide and Abiraterone in Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1315815.
- Parker, C., S. Nilsson, D. Heinrich, S.I. Helle, J.M. O'Sullivan, S.D. Fosså, A. Chodacki, et al.. 2013. “Alpha Emitter Radium-223 and Survival in Metastatic Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1213755.
- Zimmerman, B. E., D. E. Bergeron, J. T. Cessna, R. Fitzgerald, and L. Pibida. 2015. “Revision of the NIST Standard for 223 Ra: New Measurements and Review of 2008 Data”. Journal of Research of the National Institute of Standards and Technology. National Institute of Standards and Technology (NIST). doi:10.6028/jres.120.004.
- Cessna, J.T., and B.E. Zimmerman. 2010. “Standardization of Radium-223 by Liquid Scintillation Counting”. Applied Radiation and Isotopes. Elsevier BV. doi:10.1016/j.apradiso.2009.11.068.
- Petrylak, Daniel P., Catherine M. Tangen, Maha H.A. Hussain, Primo N. Lara Jr., Jeffrey A. Jones, Mary Ellen Taplin, Patrick A. Burch, et al.. 2004. “Docetaxel and Estramustine Compared with Mitoxantrone and Prednisone for Advanced Refractory Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa041318.
- Antonarakis, Emmanuel S., Changxue Lu, Hao Wang, Brandon Luber, Mary Nakazawa, Jeffrey C. Roeser, Yan Chen, et al.. 2014. “AR-V7 and Resistance to Enzalutamide and Abiraterone in Prostate Cancer”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1315815.
- Antonarakis, Emmanuel S., Changxue Lu, Brandon Luber, Hao Wang, Yan Chen, Mary Nakazawa, Rosa Nadal, et al.. 2015. “Androgen Receptor Splice Variant 7 and Efficacy of Taxane Chemotherapy in Patients with Metastatic Castration-resistant Prostate Cancer”. JAMA Oncology. American Medical Association (AMA). doi:10.1001/jamaoncol.2015.1341.
- Beer, Tomasz M., Andrew J. Armstrong, Dana E. Rathkopf, Yohann Loriot, Cora N. Sternberg, Celestia S. Higano, Peter Iversen, et al.. 2014. “Enzalutamide in Metastatic Prostate Cancer Before Chemotherapy”. New England Journal of Medicine. Massachusetts Medical Society. doi:10.1056/nejmoa1405095.
- Oudard S, Banu E, Beuzeboc P, Voog E, Dourthe LM, Hardy-Bessard AC, Linassier C, Scotte F, Banu A, Coscas Y, Guinet F, Poupon MF, Andrieu JM. Multicenter randomized phase II study of two schedules of docetaxel, estramustine, and prednisone versus mitoxantrone plus prednisone in patients with metastatic hormone-refractory prostate cancer. J Clin Oncol. 2005 May 20;23(15):3343-51. doi: 10.1200/JCO.2005.12.187. Epub 2005 Feb 28.
- Petrylak DP, Tangen CM, Hussain MH, Lara PN Jr, Jones JA, Taplin ME, Burch PA, Berry D, Moinpour C, Kohli M, Benson MC, Small EJ, Raghavan D, Crawford ED. Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer. N Engl J Med. 2004 Oct 7;351(15):1513-20. doi: 10.1056/NEJMoa041318.
- Ryan CJ, Smith MR, de Bono JS, Molina A, Logothetis CJ, de Souza P, Fizazi K, Mainwaring P, Piulats JM, Ng S, Carles J, Mulders PF, Basch E, Small EJ, Saad F, Schrijvers D, Van Poppel H, Mukherjee SD, Suttmann H, Gerritsen WR, Flaig TW, George DJ, Yu EY, Efstathiou E, Pantuck A, Winquist E, Higano CS, Taplin ME, Park Y, Kheoh T, Griffin T, Scher HI, Rathkopf DE; COU-AA-302 Investigators. Abiraterone in metastatic prostate cancer without previous chemotherapy. N Engl J Med. 2013 Jan 10;368(2):138-48. doi: 10.1056/NEJMoa1209096. Epub 2012 Dec 10. Erratum In: N Engl J Med. 2013 Feb 7;368(6):584.
- Parker C, Nilsson S, Heinrich D, Helle SI, O'Sullivan JM, Fossa SD, Chodacki A, Wiechno P, Logue J, Seke M, Widmark A, Johannessen DC, Hoskin P, Bottomley D, James ND, Solberg A, Syndikus I, Kliment J, Wedel S, Boehmer S, Dall'Oglio M, Franzen L, Coleman R, Vogelzang NJ, O'Bryan-Tear CG, Staudacher K, Garcia-Vargas J, Shan M, Bruland OS, Sartor O; ALSYMPCA Investigators. Alpha emitter radium-223 and survival in metastatic prostate cancer. N Engl J Med. 2013 Jul 18;369(3):213-23. doi: 10.1056/NEJMoa1213755.
- 2018. "Fractionated Docetaxel and Radium 223 in Metastatic Castration-Resistant Prostate Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03737370.
Frequently Asked Questions
What other experimental examinations have been conducted utilizing Docetaxel?
"Currently, there are 320 publicly listed Docetaxel trials with 126 at phase 3. Most of these studies originate from Fuzhou in Fujian province; however, clinicaltrials.gov lists 22389 sites across the world offering treatment with this drug." - Anonymous Online Contributor
Unverified Answer
What health risks has Docetaxel been linked to in patients?
"Due to limited clinical data, Docetaxel is rated a 1 on the safety scale created by our team at Power; this rating reflects that it is currently in the first phase of evaluation." - Anonymous Online Contributor
Unverified Answer
How many individuals have been recruited to participate in this experiment?
"Affirmative. Clinicaltrials.gov indicates that this trial, which was first published on January 30th 2018, is actively searching for participants. 25 individuals from 4 different sites need to be recruited." - Anonymous Online Contributor
Unverified Answer
Are people being accepted for participation in this experiment at the present time?
"Affirmative, according to clinicaltrials.gov's records this experiment is currently enrolling volunteers. It was first announced on the 30th of January 2018 and revised most recently in February 2022. The project requires 25 individuals signing up at four distinct locations." - Anonymous Online Contributor
Unverified Answer
For what maladies is Docetaxel regularly prescribed?
"Docetaxel can be utilized to combat malignant neoplasms, advance directives, and sarcoma." - Anonymous Online Contributor
Unverified Answer