- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00148772
Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising Prostate Specific Antigen (PSA) on Hormone Therapy
Phase II Study of Erlotinib in Patients With Non-Metastatic Prostate Cancer With a Rising PSA on Hormone Therapy
The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy.
The secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with various epidermal growth factor receptor (EGFR)-related proteins using baseline immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Patients with prostate cancer who are treated with surgery or radiation often develop recurrence of their cancer which is manifest only by a rising PSA (Prostate Specific Antigen) level. Many of these patients are treated with hormone therapy. After a fall in the PSA, these patients eventually display evidence of tumor progression clearly demonstrated by another rise in PSA level while receiving hormone therapy. Evaluation for evidence of tumor spread is usually negative. There is currently no effective therapy approved for use in these patients.
The drug erlotinib works by blocking the activity of a protein called Epidermal Growth Factor Receptor (EGFR), which is located on the surface of many prostate cancer cells. Blockage of this protein has been shown to inhibit the growth of prostate tumor cells in a laboratory setting and in animal experiments. Erlotinib has been given to patients with other types of cancers. A recently completed study showed that erlotinib improved the survival of patients with advanced lung cancer who failed standard chemotherapy.
There is currently no effective therapy approved for use in patients with this condition. The purpose of this study is to evaluate the effectiveness and side effects of the drug erlotinib in patients with this condition. Erlotinib is an investigational drug that has not yet been approved by the Federal Drug Administration (FDA) for use in prostate cancer, but has been approved for use in lung cancer.
As previously stated: The primary objective of this study is to evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy.
Secondary objectives are to evaluate the effect of erlotinib on the duration of PSA response, to evaluate the effect on the time to PSA progression, to evaluate the toxicity of erlotinib in this patient population, and lastly, to correlate the effect of erlotinib with various EGFR-related proteins using baseline immunohistochemical (IHC) studies on tissue blocks and peripheral blood mononuclear cells.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University
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Evanston, Illinois, États-Unis, 60201
- Evanston Northwestern Healthcare
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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:
- Patients must have documented adenocarcinoma of the prostate, treated with androgen suppression, and now present with a rising PSA .
- Prior therapy with hydrocortisone is allowed (must have discontinued > 4 weeks prior to study treatment). Prior use of ketoconazole for prostate cancer treatment is allowed (must have discontinued > 4 weeks prior to study treatment).
- Prior therapy with chemotherapy is allowed if it was administered as neoadjuvant or adjuvant therapy related to primary treatment and was completed > 6 months prior to starting study treatment.
- Testosterone level < 50 ng/dl within 4 weeks prior to study treatment. Patients who have not undergone surgical castration must continue primary androgen suppression therapy (luteinizing hormone-releasing hormone [LHRH] agonist) while on protocol therapy.
- Patients may be receiving oral bisphosphonate therapy prior to study treatment and continue while receiving treatment, but must not begin treatment with bisphosphonate while receiving study treatment. Patients on oral bisphosphonates must have completed at least 4 weeks of bisphosphonate therapy prior to study treatment.
Patients must have adequate major organ function. All values must be obtained within 4 weeks prior to study treatment.
- Creatinine < 1.7 mg/dL or a creatinine clearance > 50 mL/min,
- SGOT (AST), SGPT (ALT) < 2X the institution's upper limit of normal,
- Bilirubin < 1.5 mg/dL,
- ANC > 1500/mm3,
- Platelet (PLT) > 100,000/mm3
- Patients must have Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
- Patients must be > 18.
- Patients taking warfarin are eligible.
- Patients taking CYP3A4 inducers or inhibitors are eligible.
- Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for the specific cancer.
Exclusion Criteria:
- No previous palliative radiation. Prior radiation to the primary site is allowed.
- HIV positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with erlotinib.
- Patients with gastrointestinal tract disease resulting in an inability to take oral medication are ineligible.
- Patients must not have ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, symptomatic cardiac arrhythmia, or psychiatric illness that would limit compliance with study requirements.
- Patients must not have received prior targeted therapy, including no prior EGFR inhibitor.
- Patients must not have evidence of metastatic disease.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: La prévention
- Répartition: Non randomisé
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
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To evaluate the effect of erlotinib on the PSA response rate in patients with non-metastatic prostate cancer and a rising PSA on androgen deprivation therapy
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Mesures de résultats secondaires
Mesure des résultats |
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To evaluate the effect of erlotinib on the duration of PSA response
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To evaluate the effect of erlotinib on the time to PSA progression
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To evaluate the toxicity of erlotinib in this patient population
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To correlate the effect of erlotinib with various EGFR downstream proteins and androgen receptor, using baseline IHC studies on tissue blocks and analysis of protein phosphorylation in peripheral blood mononuclear cells
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Daniel Shevrin, MD, Northshore University Healthsystem
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- OSI3316s
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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