- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT01561014
Oxaliplatin, Fluorouracil, Erlotinib Hydrochloride, and Radiation Therapy Before Surgery and Erlotinib Hydrochloride After Surgery in Treating Patients With Locally Advanced Cancer of the Esophagus or Gastroesophageal Junction
A Phase I Study of Preoperative Chemoradiation With Oxaliplatin, 5-Fluorouracil, Erlotinib and Radiation Followed by Resection and Consolidative Erlotinib for Patients With Locally Advanced Cancer of the Esophagus and Gastroesophageal Junction
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
- Médicament: oxaliplatine
- Médicament: fluorouracile
- Radiation: radiothérapie
- Médicament: chlorhydrate d'erlotinib
- Procédure: laboratoire d'analyse de biomarqueurs
- Autre: méthode de coloration immunohistochimique
- Procédure: conventional surgery
- Procédure: positron emission tomography
- Procédure: computed tomography
- Génétique: gene expression analysis
- Radiation: fludeoxyglucose F 18
Description détaillée
OBJECTIVES:
I. The primary aim of this phase I study is to evaluate the safety of multi-drug chemotherapy (with the addition of an anti-epidermal growth factor receptor [EGFR] agent erlotinib [erlotinib hydrochloride]) and concomitant radiotherapy followed by resection and consolidative erlotinib for the treatment of locally advanced esophageal cancer as judged by the dose limiting toxicities. Correlative endpoints include an analysis of pre-treatment tumor cyclin D1 expression and EGFR expression/amplification.
III. Correlate pathologic complete response with changes in fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)-computed tomography (CT) - pre and post-chemoradiation.
OUTLINE: This is a dose escalation study of erlotinib hydrochloride
CHEMORADIOTHERAPY: Patients undergo radiation therapy once daily (QD), 5 days a week and receive fluorouracil intravenously (IV) continuously and erlotinib hydrochloride orally (PO) QD on days 1-38. Patients also receive oxaliplatin IV over 2 hours on days 1, 15, and 29.
SURGERY: Within 4-8 weeks after completion of chemoradiotherapy, patients with potentially resectable disease (i.e., complete response, partial response, or stable disease) undergo surgery to remove the tumor.
CONSOLIDATION CHEMOTHERAPY: Within 2-4 weeks after surgery, patients with tumors that demonstrate positive immunohistochemistry for EGFR and/or cyclin D1 (in the pretreatment biopsy or in the residual tumor in the esophagectomy specimen) receive consolidation chemotherapy comprising erlotinib hydrochloride PO QD for 12 weeks.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 2 years, and then annually thereafter.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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North Carolina
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Winston-Salem, North Carolina, États-Unis, 27157
- Wake Forest University Health 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:
- Newly diagnosed patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology; patients should have evidence of extension of disease into or through the wall of the esophagus (T2-4) and/or regional nodal metastasis (N1)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Non-pregnant; patients of childbearing potential and their partners must agree to use an effective form of contraception during the study and for 90 days following the last dose of study medication (an effective form of contraception is an oral contraceptive or a double barrier method); nursing mothers are also ineligible
- Prior treatment: Greater than one week shall have elapsed since any major surgery; no prior chemotherapy or radiotherapy is allowed
- Adequate whole blood cell (WBC) and platelets (Plt) as determined by medical oncology
- Serum creatinine =< 1.5 mg/dl
- Creatinine clearance >= 60 ml/min
- Hemoglobin (Hgb) >= 9.0 gm/dl
- Absolute neutrophil count >= 1,500/uL
- Serum total bilirubin =< 1.5 mg/dL
- Alkaline phosphatase =< 3X the upper limit of normal (ULN) for the reference lab
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) less than 2X ULN for the reference laboratory
- Patients must be told of the investigational nature of the study and must sign a written informed consent
- No serious medical or psychiatric illnesses which would prevent informed consent or otherwise limit survival to less than two years; no history of refractory congestive heart failure or cardiomyopathy
- Patients should be evaluated by medical oncology, radiation oncology, and surgery, and felt to by all to be suitable for trimodality therapy
Exclusion Criteria:
Patients with an active infection or with a fever >= 38.5 degrees Celsius (C) within 3 days of the first scheduled day of protocol treatment
- History of prior malignancy within the past 5 years except for curatively treated basal cell carcinoma of the skin, cervical intra-epithelial neoplasia, or localized prostate cancer with a current prostate surface antigen (PSA) of < 1.0 mg/dL on 2 successive evaluations, at least 3 months apart, with the most recent evaluation no more than 4 weeks prior to entry
- Patients with known hypersensitivity to any of the components of oxaliplatin
- Patients who are receiving concurrent investigational therapy or who have received investigational therapy within 30 days of the first scheduled day of protocol treatment (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication)
- Peripheral neuropathy >= Grade 2
- History of allogeneic transplant
- Known human immunodeficiency virus (HIV) or Hepatitis B or C (active, previously treated or both)
- Pregnancy
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 (chemotherapy, enzyme inhibitor therapy)
CHEMORADIOTHERAPY: Patients undergo radiation therapy QD, 5 days a week and receive fluorouracil IV continuously and erlotinib hydrochloride PO QD on days 1-38. Patients also receive oxaliplatin IV over 2 hours on days 1, 15, and 29. SURGERY: Within 4-8 weeks after completion of chemoradiotherapy, patients with potentially resectable disease (i.e., complete response, partial response, or stable disease) undergo surgery to remove the tumor. CONSOLIDATION CHEMOTHERAPY: Within 2-4 weeks after surgery, patients with tumors that demonstrate positive immunohistochemistry for EGFR and/or cyclin D1 (in the pretreatment biopsy or in the residual tumor in the esophagectomy specimen) receive consolidation chemotherapy comprising erlotinib hydrochloride PO QD for 12 weeks. |
Étant donné IV
Autres noms:
Étant donné IV
Autres noms:
Subir une radiothérapie
Autres noms:
Bon de commande donné
Autres noms:
Étude corrélative
Étude corrélative
Autres noms:
Undergo surgical resection
Autres noms:
Correlative study
Autres noms:
Correlative study
Autres noms:
Correlative study
Undergo F18 PET and CT scan
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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Toxicity rate of combination chemotherapy followed by surgery and erlotinib hydrochloride
Délai: Approximately 6 months
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Toxicity will be determined using the revised National Cancer Institute (NCI) Common Toxicity Criteria (CTC) version 3.0 for Toxicity and Adverse Event Reporting (CTCAE v3.0).
The dose limiting toxicity will be defined as any of the following that can be attributal to therapy: Any grade 4 neutropenia and or any grade 4 thrombocytopenia, or any >= grade 3 non-hematologic toxicity that results in a greater than 3 day interruption of therapy.
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Approximately 6 months
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Mesures de résultats secondaires
Mesure des résultats |
Délai |
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Time to progression
Délai: Approximately 4 years
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Approximately 4 years
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Survival
Délai: Approximately 4 years
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Approximately 4 years
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Specific characteristics that predict complete response rate (e.g., EGFR status, EGFR amplification, and cyclin D1 expression)
Délai: Over 4 years
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Over 4 years
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Specific characteristics that predict complete response rate (e.g., EGFR status, EGFR amplification, and cyclin D1 expression)
Délai: Approximately 1 year
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Approximately 1 year
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Test the predictive value of FDG-PET-CT imaging in identifying patients who will have a complete response
Délai: Approximately 1 year
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Approximately 1 year
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
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
- Maladies du système digestif
- Tumeurs par type histologique
- Tumeurs
- Tumeurs par site
- Carcinome
- Tumeurs, glandulaires et épithéliales
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Maladies de l'estomac
- Tumeurs de la tête et du cou
- Maladies de l'oesophage
- Tumeurs à cellules squameuses
- Carcinome épidermoïde
- Tumeurs de l'estomac
- Adénocarcinome
- Tumeurs de l'oesophage
- Carcinome épidermoïde de l'œsophage
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Radiopharmaceutiques
- Inhibiteurs de protéine kinase
- Fluorodésoxyglucose F18
- Chlorhydrate d'erlotinib
- Fluorouracile
- Oxaliplatine
Autres numéros d'identification d'étude
- IRB00007063
- NCI-2009-01447 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- CCCWFU 60106 (Autre identifiant: Wake Forest University Health Sciences)
Informations sur les médicaments et les dispositifs, documents d'étude
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