- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00539617
Chemotherapy & Erlotinib in Treating Patients w/ Esophageal or Gastroesophageal Cancer That Cannot Be Removed by Surgery
A Single-Arm, Phase II Study of Tarceva Plus FOLFOX6 in Patients With Unresectable or Metastatic Cancer of Esophagus or Gastroesophageal Junction
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Type d'étude
Inscription (Réel)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
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California
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San Francisco, California, États-Unis, 94115
- University of California, San Francisco
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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 confirmed esophageal carcinoma (squamous or adenocarcinoma)
- Surgically unresectable disease and/or metastatic disease; endoscopic accessibility of the primary tumor is preferred but not a prerequisite
- No prior chemotherapy therapy except for neoadjuvant treatment (radiation and/or chemotherapy); prior treatment with EGFR-inhibiting agents is not allowed
- Life expectancy > 12 weeks
- Patients must have the ability to take and retain oral medications or have an appropriate percutaneous feeding tube in place
- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2 (Karnofsky Performance Status (KPS) >= 50%)
- Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) criteria and radiographic imaging performed within 28 days prior to registration
- Absolute neutrophil count (ANC) >= 1500/mL
- Platelet count >= 100,000/mL
- Hemoglobin level >= 10.0 gm/dL
- Serum creatinine =< 1.5 x IULN (institutional upper limits of normal); OR measured creatinine clearance >= 60 mL/min
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase (SGOT)) or alanine aminotransferase (ALT) (serum glutamic pyruvate transaminase (SGPT)) =< 2.5 x IULN (unless the liver is involved by tumor, in which case it must be =< 5.0 x IULN)
- Total bilirubin =< 1.5 x IULN
- Provision of written informed consent
- Women of childbearing potential (WOCBP) must be willing to practice acceptable methods of birth control to prevent pregnancy; WOCBP are any females who have experienced menarche and who have not undergone surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy), who are not postmenopausal (defined as amenorrhea >= 12 consecutive months), or are on hormone replacement therapy; acceptable methods of birth control include oral or hormonal contraceptives and barrier methods (e.g., condom, diaphragm) used in combination with other methods (e.g., spermicide)
- Male patients who are capable of fathering a child must avoid doing so while participating in this study through the use of acceptable methods of birth control; this is a precautionary measure because this study involves chemotherapy agents
Exclusion Criteria:
- Presence of a Kras mutation
- Lack of expression of EGFR (tumors that do not have detectable EGFR staining in at least 10% of tumor cells will not be considered EGFR-positive)
- Prior treatment with EGFR-inhibiting agents, chemotherapy, or radiotherapy for esophagogastric carcinomas (other than neoadjuvant treatment as noted in inclusion criteria)
- Patients must not be receiving any other investigational agents; use of erythropoietin is allowable; secondary prophylaxis with granulocyte colony stimulating factor (G-CSF) (Filgrastim) is allowable
- The patient concomitantly uses phenytoin, carbamazepine, barbiturates, rifampicin, phenobarbital, or St. John's wort
- Uncontrolled brain metastases
- Patients must not have uncontrolled intercurrent illness at the time of registration including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina, pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Patients must not have current New York Heart Association Class III or IV heart disease
- Known human immunodeficiency virus (HIV) infection
- Pregnant or breast-feeding women
- Patients who have had prior malignancies, except non-melanoma skin cancer (basal or squamous cell carcinoma) are not eligible for this study; unless greater than 5 years has passed since the event
- Known severe hypersensitivity to Tarceva
- Treatment with a non-approved or investigational drug within 30 days before day 1 of trial treatment
- Incomplete healing from previous oncologic or other major surgery
- Serum creatinine level greater than Common Toxicity Criteria (CTC) grade 2
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 |
---|---|
Expérimental: Tarceva and FOLFOX
COMBINATION THERAPY PHASE: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1-56. Patients also receive FOLFOX6 therapy comprising oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 46-48 hours on days 1, 15, 29, and 43. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients with stable disease or no evidence of disease after course 2 or subsequent courses continue on to maintenance phase. MAINTENANCE PHASE: Patients receive erlotinib hydrochloride PO QD on days 1-42. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. |
Tarceva single agent therapy: 150 mg/day PO
Autres noms:
5-FU bolus: 400 mg/m2 IV once every 2 weeks for 16 weeks 5-FU infusion: 2400 mg/m2 IV over 46-48 hours, once every 2 weeks for 16 weeks
Autres noms:
400 mg/m2 IV once every 2 weeks for 16 weeks
Autres noms:
85 mg/m2 IV once every 2 weeks for 16 weeks
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Progression Free Survival (PFS)
Délai: Up to 2 years
|
PFS is defined as the duration of time from enrollment into the run-in period of the study to objective tumor progression as determined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
The proportion of patients with PFS will be reported and evaluated using Kaplan-Meier survival curves with median survival and 95% confidence interval.
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Up to 2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Objective Response Rate (RR)
Délai: Up to 2 years
|
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for Progressive Disease (PD) the smallest measurements recorded since the treatment started).
Best response assignment will depend on the achievement of both measurement and confirmation criteria using RECIST for both target and non-target lesions.
For target lesions, response is defined as follows: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >= 30% decrease in sum of the LD, taking as reference the baseline sum LD; PD: >=20% increase in sum of the LD of target lesions, taking as reference smallest sum LD recorded since treatment started or appearance of one or more new lesions , Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
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Up to 2 years
|
Time to Progression (TTP)
Délai: Up to 2 years
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Patient with objective tumor response or stable disease will be treated with single agent Tarceva until tumor progression.
For this study, time to progression will be determined as the number of days following the first day of single agent treatment with Tarceva following the last and completed cycle of Tarcerva/FOLFOX combination therapy.
TTP will be calculated for the entire patient population as well as for patients that objectively responded to the combination therapy versus those that did not.
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Up to 2 years
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: W. Michael Korn, MD, University of California, San Francisco
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
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Tumeurs
- Tumeurs par site
- Tumeurs gastro-intestinales
- Tumeurs du système digestif
- Maladies gastro-intestinales
- Tumeurs de la tête et du cou
- Maladies de l'oesophage
- Tumeurs de l'oesophage
- Effets physiologiques des médicaments
- Mécanismes moléculaires de l'action pharmacologique
- Inhibiteurs d'enzymes
- Antimétabolites, Antinéoplasique
- Antimétabolites
- Agents antinéoplasiques
- Agents immunosuppresseurs
- Facteurs immunologiques
- Agents protecteurs
- Micronutriments
- Inhibiteurs de protéine kinase
- Vitamines
- Antidotes
- Complexe de vitamine B
- Chlorhydrate d'erlotinib
- Fluorouracile
- Oxaliplatine
- Leucovorine
Autres numéros d'identification d'étude
- 064511
- NCI-2011-01276 (Identificateur de registre: NCI Clinical Trial Reporting Program (CTRP))
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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