A Study of Picoplatin and Docetaxel in Subjects With Prostate Cancer
NCT ID: NCT00448734
Last Updated: 2009-01-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE1/PHASE2
95 participants
INTERVENTIONAL
2006-06-30
2010-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors
NCT00084734
Safety and Clinical Pharmacology of GDC-0068 in Combination With Docetaxel, Fluoropyrimidine Plus Oxaliplatin, Paclitaxel, or Enzalutamide in Participants With Advanced Solid Tumors
NCT01362374
Paclitaxel, Ifosfamide, and Cisplatin in Treating Patients With Metastatic Testicular Cancer
NCT00004077
Oxaliplatin and Capecitabine in the Treatment of Relapsed/Refractory Carcinoma of Unknown Primary Site
NCT00193609
Palbociclib With Cisplatin or Carboplatin in Advanced Solid Tumors
NCT02897375
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.
Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.
Picoplatin
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.
Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.
2
Docetaxel
docetaxel
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.
Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Picoplatin
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.
Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.
docetaxel
The treatment regimen will be the assigned dose of picoplatin plus docetaxel, 60 mg/m2 or 75 mg/m2, once every three weeks, plus prednisone (or prednisolone, if prednisone is not available), 5 mg orally twice daily beginning on day 1 and continuing daily until therapy is discontinued.
Docetaxel will be given intravenously over 60 minutes, followed 30 minutes later by picoplatin as a 1-2 hour intravenous infusion.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Radiologic evidence of metastatic disease (Jewett-Whitmore Stages D1-D2 or TNM Stage N1-3 or M1).
* Disease progression or recurrence documented by either: increasing serum PSA on three consecutive measurements each obtained at least one week apart, or findings on radiographic imaging studies.
* Non-surgically castrate subjects must be receiving androgen ablation therapy as maintenance therapy.
* Adequate hormonal therapy as documented by a castrate level of serum testosterone (all subjects without surgical castration must have a serum testosterone less than 50 ng/ml).
* At least 4 weeks must have elapsed after the withdrawal of antiandrogens (6 weeks in the case of bicalutamide).
* Age 18 years and over. Subjects older than 80 years should be entered on study only if considered "physiologically appropriate" for combination chemotherapy.
* ECOG performance score (PS) of 0 or 1.
* Stable levels of pain for at least 7 days before study entry.
* Life expectancy more than 3 months.
* At least 28 days must have elapsed since prior radiotherapy.
* At least 28 days must have elapsed since any prior investigational agent.
* Absolute neutrophil count (ANC) at least 1.5 x 10\^9th/L.
* Platelet count at least 100 x 10\^9th/L.
* Hemoglobin at least 10 g/dL.
* Serum AST and ALT levels ≥ 1.5 times upper limit of normal (ULN).
* Serum bilirubin ≤ ULN.
* Serum creatinine ≤ ULN.
* All subjects must agree to use appropriate birth control methods while on study and until 1 month after completion of study chemotherapy.
Exclusion Criteria
* Clinical evidence of brain or leptomeningeal metastases.
* Symptomatic peripheral neuropathy of Grade 2 or higher.
* History of another cancer within the preceding 5 years, except for superficial skin cancers.
* Known hypersensitivity to drugs formulated with Polysorbate 80.
* Prior radiotherapy that included ≥ 30% of the bone marrow (e.g., the whole of the pelvis or half of the spine).
* Uncontrolled intercurrent illness (e.g., active infection).
* Serious medical or psychiatric illness that could potentially interfere with the completion of the study treatment according to this protocol.
* History of serious cardiac disease, defined as myocardial infarction within six months of enrollment, congestive heart failure classified by the New York Heart Association as Class III or IV, uncontrolled cardiac arrhythmias, poorly controlled or unstable angina, or electrocardiographic evidence of acute ischemia.
18 Years
MALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Poniard Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Poniard Pharmaceuticals
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Robert Earhart, MD
Role: STUDY_DIRECTOR
Poniard Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical Radiology Research Center under the Russian Academy of Medical Sciences
Obninsk, Kaluga Oblast, Russia
Chelyabinsk Regional Oncology Center
Chelyabinsk, , Russia
Burdenko Central Military Clinical Hospital
Moscow, , Russia
Russian Research Center of Radiology
Moscow, , Russia
Research Institute of Urology - Ministry of Health
Moscow, , Russia
Leningrad Regional Oncology Center
Saint Petersburg, , Russia
Central Medical Unit #122
Saint Petersburg, , Russia
Therapeutic and Research Medical Center
Saint Petersburg, , Russia
St. Petersburg City Hospital #26
Saint Petersburg, , Russia
St. Petersburg City Oncology Center
Saint Petersburg, , Russia
State Medical Institution of Yaroslavl Region / Regional Clinical Oncology Hospital
Yaroslavl, , Russia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Beale P, Judson I, O'Donnell A, Trigo J, Rees C, Raynaud F, Turner A, Simmons L, Etterley L. A Phase I clinical and pharmacological study of cis-diamminedichloro(2-methylpyridine) platinum II (AMD473). Br J Cancer. 2003 Apr 7;88(7):1128-34. doi: 10.1038/sj.bjc.6600854.
Canobbio L, Guarneri D, Miglietta L, Decensi A, Oneto F, Boccardo F. Carboplatin in advanced hormone refractory prostatic cancer patients. Eur J Cancer. 1993;29A(15):2094-6. doi: 10.1016/0959-8049(93)90040-m.
Douillard JY, Schiller J. ZD0473 combined with other chemotherapeutic agents for the treatment of solid malignancies. Eur J Cancer. 2002 Dec;38 Suppl 8:S25-31. doi: 10.1016/s0959-8049(02)80020-x.
Gelmon KA, Stewart D, Chi KN, Chia S, Cripps C, Huan S, Janke S, Ayers D, Fry D, Shabbits JA, Walsh W, McIntosh L, Seymour LK. A phase I study of AMD473 and docetaxel given once every 3 weeks in patients with advanced refractory cancer: a National Cancer Institute of Canada-Clinical Trials Group trial, IND 131. Ann Oncol. 2004 Jul;15(7):1115-22. doi: 10.1093/annonc/mdh278.
Holford J, Raynaud F, Murrer BA, Grimaldi K, Hartley JA, Abrams M, Kelland LR. Chemical, biochemical and pharmacological activity of the novel sterically hindered platinum co-ordination complex, cis-[amminedichloro(2-methylpyridine)] platinum(II) (AMD473). Anticancer Drug Des. 1998 Jan;13(1):1-18.
Holford J, Sharp SY, Murrer BA, Abrams M, Kelland LR. In vitro circumvention of cisplatin resistance by the novel sterically hindered platinum complex AMD473. Br J Cancer. 1998;77(3):366-73. doi: 10.1038/bjc.1998.59.
Rogers P, Boxall FE, Allott CP, Stephens TC, Kelland LR. Sequence-dependent synergism between the new generation platinum agent ZD0473 and paclitaxel in cisplatin-sensitive and -resistant human ovarian carcinoma cell lines. Eur J Cancer. 2002 Aug;38(12):1653-60. doi: 10.1016/s0959-8049(02)00107-7.
Related Links
Access external resources that provide additional context or updates about the study.
Poniard Pharmaceuticals, Inc.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
0502
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.