- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00405405
Phase I of Biologics and Chemoradiation Therapy for Advanced Head and Neck Cancer
A Phase I Study of the Combination of Chemoradiotherapy With Biologic Therapy for Advanced Head and Neck Cancer
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Locally advanced non-operative, Stage IV head and neck cancer has at best a guarded prognosis. Improvements in outcome have been achieved via the combination of chemotherapy and radiotherapy. Concurrent chemoradiotherapy is needed to optimize results, although recent data suggest a benefit from induction therapy as well. Nonetheless, despite high remission rates, most of these patients will suffer local-regional and/or distant recurrence from their disease.
The proposed study will build upon the framework of chemoradiotherapy (induction plus concurrent) via the addition of a double biologic therapy. Specifically, the combination of bevacizumab and erlotinib will be used, as has been studied in other types of cancer.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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Pennsylvania
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Philadelphia, Pennsylvania, États-Unis, 19107
- Thomas Jefferson 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
Inclusion Criteria:
- Locally advanced Carcinoma (epithelial malignancy) of the head and neck. This may include non-squamous carcinomas (e.g. parotid, thyroid, melanoma) in which a large portion of mucosa of the oral cavity and/or laryngopharynx is expected to be irradiated.
- Stage IV disease (T4Nany or TanyN2-3).
- "Oligometastatic" disease is allowable if it is asymptomatic.
- Measurable disease is not required; patients who have had surgical resection are eligible provided that it is felt that the likelihood of cure with conventional postoperative therapy is <40% and provided that there will be at least 28 days from the date of surgery to the start of study therapy.
- Performance status 0-1.
- Creatinine < or = 1.5 mg/dl.
- ANC > or = 1,800 cells/mm3.
- Platelets > or = 150,000 cells/mm3.
- Hemoglobin > or = 10 g/dl (transfusion is acceptable if needed).
- SGOT and/or SGPT < or = 2.5 times the upper institutional limit of normal.
- INR < or = 2.0.
- Age > or = 18 (informed consent).
Exclusion Criteria:
- Current, recent (within 4 weeks of the Day 1, the first infusion of drug in this study) or planned participation in an experimental drug study other than this one.
- Poorly controlled blood pressure, defined as systolic bp > 150 and/or diastolic bp > 100 despite medication.
- Unstable angina.
- NY Heart Association (NYHA) Grade II or greater congestive heart failure.
- History of myocardial infarction or stroke within 6 months.
- Clinically significant peripheral vascular disease.
- Evidence of bleeding diathesis or coagulopathy.
- Presence of brain or spinal cord metastases.
- Major surgical procedure(s), open biopsy or significant traumatic injury within 28 days prior to Day 1 (1st day of study treatment) and/or anticipation of need for major surgical procedure during the course of the study.
- Urine protein: Creatinine ratio > or = 1.0 at screening.*
- Carotid artery exposure or other signs of impending carotid artery hemorrhage.
- History of abdominal fistula and/or gastrointestinal abdominal abscess within 6 months prior to enrollment.
- Serious, non-healing wound, ulcer, or bone fracture.
- Prior irradiation that would result in radiotherapy field "overlap."
- Requirement for high dose oral anticoagulation (i.e., goal INR > 2.0). "Mini-dose" anticoagulation as may be used to assist in patency of central venous lines is acceptable. Subcutaneous Low-molecular weight heparin is allowable.
- No known allergies to any of the drug therapies being used in this protocol.
- No pregnancy, lactation or inability to use medically acceptable birth control if of childbearing potential.
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)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Treatment
A combination of Cisplatin, Docetaxel, Bevacizumab, Erlotinib, and Radiotherapy
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Autres noms:
Autres noms:
Autres noms:
Autres noms:
Radiotherapy begins as soon as possible following neoadjuvant chemotherapy, and continues for 7 weeks
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Bevacizumab and Erlotinib Combined with Chemoradiotherapy for the Treatment of Advanced Head and Neck Cancer
Délai: Day 36
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To determine if bevacizumab and erlotinib can be safely combined with chemoradiotherapy for advanced head and neck cancer.
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Day 36
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Determination of Dose Limiting Toxicity (DTL)
Délai: 30 days
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To determine the appropriate dosing strategy for bevacizumab/erlotinib when combined with chemoradiotherapy for advanced head and neck cancer.
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30 days
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Complete Remission Rate
Délai: 6 months
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To obtain preliminary data on the complete remission rate for this treatment combination.
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6 months
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Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Pramila Rani Anne, MD, Thomas Jefferson University
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 (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
- Tumeurs par type histologique
- Tumeurs
- Tumeurs par site
- Maladies du système endocrinien
- Tumeurs des glandes endocrines
- Maladies thyroïdiennes
- Tumeurs neuroectodermiques
- Tumeurs, cellules germinales et embryonnaires
- Tumeurs, tissu nerveux
- Tumeurs neuroendocrines
- Nevi et mélanomes
- Tumeurs de la tête et du cou
- Mélanome
- Tumeurs thyroïdiennes
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Agents antinéoplasiques
- Modulateurs de tubuline
- Agents antimitotiques
- Modulateurs de mitose
- Agents antinéoplasiques immunologiques
- Inhibiteurs de l'angiogenèse
- Agents modulateurs de l'angiogenèse
- Substances de croissance
- Inhibiteurs de croissance
- Inhibiteurs de protéine kinase
- Docétaxel
- Chlorhydrate d'erlotinib
- Cisplatine
- Bévacizumab
Autres numéros d'identification d'étude
- 06C.46
- 2005-58 (Autre identifiant: CCRRC)
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