Calcitriol, Mitoxantrone, and Prednisone in Treating Patients With Metastatic Prostate Cancer
Phase II Study of DN-101 (High Dose Pulse Calcitriol), Mitoxantrone, Prednisone in Androgen-Independent Prostate Cancer (AIPC)
RATIONALE: Calcitriol may cause prostate cancer cells to look more like normal cells, and to grow and spread more slowly. Drugs used in chemotherapy, such as mitoxantrone and prednisone, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well giving calcitriol together with mitoxantrone and prednisone works in treating patients with metastatic prostate cancer.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
OBJECTIVES:
Primary
- Determine the prostate-specific antigen (PSA) response rate, defined as the fraction of patients with 50% reduction in PSA level over 3 weeks' time, in patients with androgen-independent metastatic prostate cancer treated with high-dose pulse calcitriol, mitoxantrone, and prednisone.
Secondary
- Determine the safety and tolerability of this regimen in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral high dose pulse calcitriol on day 1, mitoxantrone IV on day 2, and oral prednisone on days 1-21. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 48 patients will be accrued for this study.
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
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Oregon
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Portland, Oregon, États-Unis, 97239-3098
- Cancer Institute at Oregon Health and Science University
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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
DISEASE CHARACTERISTICS:
Histologically confirmed prostate cancer
Androgen-independent disease, defined as disease progression while on standard hormonal management, including antiandrogen withdrawal
- Patients must continue primary hormonal therapy during study treatment
- Regional or distant metastases
- Prostate-specific antigen > 5 ng/mL
- No brain metastases
PATIENT CHARACTERISTICS:
Age
- 18 to 100
Performance status
- ECOG 0-3
Life expectancy
- Not specified
Hematopoietic
- Adequate hematologic function
Hepatic
- Adequate hepatic function
Renal
- Adequate renal function
- No calcium-salt kidney stones within the past 5 years
- No hypercalcemia
Cardiovascular
- Adequate cardiac function
- No significant cardiac disease
- No atrial fibrillation
Other
- Fertile patients must use effective barrier contraception during and for 2 months after completion of study treatment
- No other serious medical illness
- No other active malignancy except nonmelanoma skin cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy
- More than 28 days since prior biologic therapy
Chemotherapy
- No prior chemotherapy
Endocrine therapy
- See Disease Characteristics
Radiotherapy
- No prior strontium chloride Sr 89
- More than 28 days since prior radiotherapy
- More than 56 days since prior samarium Sm 153 lexidronam pentasodium
Surgery
- Prior prostatectomy and/or orchiectomy allowed
Other
- More than 28 days since prior investigational therapy
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- 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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Reduction in serum prostate-specific antigen (PSA) by 50% measured every 21 days
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Mesures de résultats secondaires
Mesure des résultats |
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Toxicity as measured by Common Toxicity Criteria v3.0
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Frozen plasma and serum samples for correlative biomarker analysis collected every 21 days
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Confirmed PSA reduction > 75% measured every 21 days
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PSA normalization (< 4 ng/mL) measured every 21 days
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Response to measurable disease as measured by RECIST criteria every 9 weeks
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Analgesic response as measured by McGill-Melzack Pain Questionnaire every 21 days
|
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Analgesic medication use decreased by ≥ 50% without an increase in pain for 2 consecutive evaluations at least 3 weeks apart
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Palliative response as measured by McGill-Melzack Pain Questionnaire every 21 days
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Quality of life as measured by EORTC core questionnaire Quality of Life-C30 every 21 days
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Time to palliative-progression as measured by McGill-Melzack Pain Questionnaire every 21 days
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Time to PSA progression measured every 21 days
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Time to progression in measurable or evaluable disease as measured by whole body scan and/or CT or MRI scan every 9-12 weeks
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Time to death assessed every 6 months after completion of study treatment
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Christopher W. Ryan, MD, OHSU Knight Cancer Institute
Publications et liens utiles
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 (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Tumeurs
- Tumeurs urogénitales
- Tumeurs par site
- Tumeurs génitales, homme
- Maladies de la prostate
- Tumeurs prostatiques
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Agents du système nerveux périphérique
- Inhibiteurs d'enzymes
- Analgésiques
- Agents du système sensoriel
- Agents anti-inflammatoires
- Agents antinéoplasiques
- Glucocorticoïdes
- Les hormones
- Hormones, substituts hormonaux et antagonistes hormonaux
- Agents antinéoplasiques, hormonaux
- Inhibiteurs de la topoisomérase II
- Inhibiteurs de la topoisomérase
- Micronutriments
- Modulateurs de transport membranaire
- Vitamines
- Agents de conservation de la densité osseuse
- Hormones et agents régulateurs du calcium
- Agents vasoconstricteurs
- Agonistes des canaux calciques
- Prednisone
- Mitoxantrone
- Calcitriol
Autres numéros d'identification d'étude
- CDR0000441172
- OHSU-8451
- OHSU-VA-IRB-9451
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