- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00448734
A Study of Picoplatin and Docetaxel in Subjects With Prostate Cancer
A Phase 1/2 Study of Picoplatin and Docetaxel (With Prednisone) in Subjects With Chemotherapy-Naive Metastatic Hormone-Refractory Prostate Cancer
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Oczekiwany)
Faza
- Faza 2
- Faza 1
Kontakty i lokalizacje
Lokalizacje studiów
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Chelyabinsk, Federacja Rosyjska, 454087
- Chelyabinsk Regional Oncology Center
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Moscow, Federacja Rosyjska, 105229
- Burdenko Central Military Clinical Hospital
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Moscow, Federacja Rosyjska, 117997
- Russian Research Center of Radiology
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Moscow, Federacja Rosyjska
- Research Institute of Urology - Ministry of Health
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St. Petersburg, Federacja Rosyjska, 188663
- Leningrad Regional Oncology Center
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St. Petersburg, Federacja Rosyjska, 194291
- Central Medical Unit #122
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St. Petersburg, Federacja Rosyjska, 194354
- Therapeutic and Research Medical Center
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St. Petersburg, Federacja Rosyjska, 196247
- St. Petersburg City Hospital #26
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St. Petersburg, Federacja Rosyjska, 198255
- St. Petersburg City Oncology Center
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Yaroslavl, Federacja Rosyjska, 150054
- State Medical Institution of Yaroslavl Region / Regional Clinical Oncology Hospital
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Kaluga Region
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Obninsk, Kaluga Region, Federacja Rosyjska, 249036
- Medical Radiology Research Center under the Russian Academy of Medical Sciences
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Histologically or cytologically confirmed adenocarcinoma of the prostate.
- 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:
- Prior treatment with cytotoxic agents (except estramustine), radioisotopes, or biological therapies other than hormones.
- 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.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Nielosowe
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: 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. |
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. |
Aktywny komparator: 2
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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
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In Part 1, the Maximum Tolerated Dose (MTD) will be determined
Ramy czasowe: MTD
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MTD
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In Part 2, PSA response will be measured (reduction of at least 50% of PSA from baseline, with reduction maintained for at least 4 weeks)
Ramy czasowe: response
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response
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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Progression free survival
Ramy czasowe: progression
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progression
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Współpracownicy i badacze
Sponsor
Śledczy
- Dyrektor Studium: Robert Earhart, MD, Poniard Pharmaceuticals
Publikacje i pomocne linki
Publikacje ogólne
- 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.
- 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.
- 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.
- 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.
Przydatne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 0502
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