- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00077545
3-AP Plus Cisplatin in Treating Patients With Recurrent or Metastatic Adenocarcinoma of the Esophagus or Gastroesophageal Junction
A Phase II Study Of Triapine In Combination With Cisplatin Esophageal Carcinoma
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with recurrent or metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with 3-AP (Triapine) and cisplatin.
SECONDARY OBJECTIVES:
I. Determine the toxicity of this regimen in these patients. II. Determine the duration of response and overall survival of patients treated with this regimen.
III. Determine the palliative benefits with regard to dysphagia in patients treated with this regimen.
OUTLINE: This is a multicenter study.
Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4. Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed for up to 2 years.
PROJECTED ACCRUAL: A total of 19-39 patients will be accrued for this study within 20 months.
Type d'étude
Inscription (Anticipé)
Phase
- Phase 2
Contacts et emplacements
Lieux d'étude
-
-
Illinois
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Chicago, Illinois, États-Unis, 60637-1470
- University of Chicago Comprehensive Cancer Center
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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 or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
- Metastatic or recurrent disease
Measurable disease
- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
- Outside prior irradiation port
- No known brain metastases
- Performance status - ECOG 0-2
- Performance status - Karnofsky 50-100%
- More than 6 months
- Absolute neutrophil count ≥ 1,500/mm^3
- WBC ≥ 3,000/mm ^3
- Platelet count ≥ 100,000/mm^3
- AST and ALT ≤ 2.5 times upper limit of normal
- Bilirubin normal
- Creatine normal
- Creatinine clearance ≥ 50 mL/min
- No prior myocardial infarction
- No unstable angina
- No cardiac arrhythmia
- No uncontrolled congestive heart failure
- No pulmonary disease requiring supplemental oxygen
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study participation
- No glucose-6-phosphate dehydrogenase (G6PD) deficiency (for patients of African, Asian, or Mediterranean origin)
- No other concurrent uncontrolled illness
- No active or ongoing infection
- No active second malignancy
- No prior allergic reaction to compounds of similar chemical or biological composition to 3-AP or other study agents
- No psychiatric illness or social situation that would preclude study compliance
- At least 1 year since prior platinum-derivative agents
- No prior chemotherapy for metastatic or recurrent esophageal cancer
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy and recovered
- No other concurrent anticancer therapy
- No other concurrent investigational agents
- No concurrent combination antiretroviral therapy for HIV-positive patients
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: Treatment (triapine and cisplatin)
Patients receive 3-AP (Triapine) IV over 2 hours on days 1-4.
Patients also receive cisplatin IV over 60 minutes on days 2 and 3 before 3-AP infusion.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
|
Étant donné IV
Étant donné IV
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Complete response rate
Délai: Up to 2 years
|
Will be calculated together with 95% confidence intervals based on the binomial distribution.
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Up to 2 years
|
|
Objective response rate (CR + PR)
Délai: Up to 2 years
|
Will be calculated together with 95% confidence intervals based on the binomial distribution.
|
Up to 2 years
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
La survie globale
Délai: Jusqu'à 2 ans
|
Les estimations de Kaplan-Meier seront déterminées.
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Jusqu'à 2 ans
|
|
Progression-free survival
Délai: From the start of treatment to progression or death, assessed up to 2 years
|
Kaplan-Meier estimates will be determined.
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From the start of treatment to progression or death, assessed up to 2 years
|
|
Duration of response
Délai: From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
|
From the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, assessed up to 2 years
|
|
|
Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0
Délai: Up to 2 years
|
Up to 2 years
|
|
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Number of patients with improvement of dysphagia
Délai: Up to 2 years
|
Up to 2 years
|
|
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Duration of improvement of dysphagia
Délai: Up to 2 years
|
Up to 2 years
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Ann Mauer, University of Chicago Comprehensive Cancer Center
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (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
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
- Tumeurs de la tête et du cou
- Maladies de l'oesophage
- Adénocarcinome
- Tumeurs de l'oesophage
- Agents antinéoplasiques
- Cisplatine
Autres numéros d'identification d'étude
- NCI-2012-02576 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
- N01CM62201 (Subvention/contrat des NIH des États-Unis)
- CDR0000352307
- UCCRC-12765A
- NCI-6285
- 12765A (Autre identifiant: University of Chicago Comprehensive Cancer Center)
- 6285 (Autre identifiant: CTEP)
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