- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
- La phase 1
Contacts et emplacements
Lieux d'étude
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Chelyabinsk, Fédération Russe, 454087
- Chelyabinsk Regional Oncology Center
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Moscow, Fédération Russe, 105229
- Burdenko Central Military Clinical Hospital
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Moscow, Fédération Russe, 117997
- Russian Research Center of Radiology
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Moscow, Fédération Russe
- Research Institute of Urology - Ministry of Health
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St. Petersburg, Fédération Russe, 188663
- Leningrad Regional Oncology Center
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St. Petersburg, Fédération Russe, 194291
- Central Medical Unit #122
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St. Petersburg, Fédération Russe, 194354
- Therapeutic and Research Medical Center
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St. Petersburg, Fédération Russe, 196247
- St. Petersburg City Hospital #26
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St. Petersburg, Fédération Russe, 198255
- St. Petersburg City Oncology Center
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Yaroslavl, Fédération Russe, 150054
- State Medical Institution of Yaroslavl Region / Regional Clinical Oncology Hospital
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Kaluga Region
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Obninsk, Kaluga Region, Fédération Russe, 249036
- Medical Radiology Research Center under the Russian Academy of Medical Sciences
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Non randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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. |
Comparateur actif: 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. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
---|---|
In Part 1, the Maximum Tolerated Dose (MTD) will be determined
Délai: 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)
Délai: response
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response
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
---|---|
Progression free survival
Délai: progression
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progression
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Robert Earhart, MD, Poniard Pharmaceuticals
Publications et liens utiles
Publications générales
- 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.
Liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 0502
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