- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Voraussichtlich)
Phase
- Phase 2
Kontakte und Standorte
Studienorte
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-
Illinois
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Chicago, Illinois, Vereinigte Staaten, 60637-1470
- University of Chicago Comprehensive Cancer Center
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: N / A
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: 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.
|
Gegeben IV
Gegeben IV
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Complete response rate
Zeitfenster: 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
|
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Objective response rate (CR + PR)
Zeitfenster: Up to 2 years
|
Will be calculated together with 95% confidence intervals based on the binomial distribution.
|
Up to 2 years
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Gesamtüberleben
Zeitfenster: Bis zu 2 Jahre
|
Kaplan-Meier-Schätzungen werden ermittelt.
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Bis zu 2 Jahre
|
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Progression-free survival
Zeitfenster: From the start of treatment to progression or death, assessed up to 2 years
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Kaplan-Meier estimates will be determined.
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From the start of treatment to progression or death, assessed up to 2 years
|
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Duration of response
Zeitfenster: 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
|
|
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Number of patients with various treatment-related toxicities assessed using NCI CTCAE version 3.0
Zeitfenster: Up to 2 years
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Up to 2 years
|
|
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Number of patients with improvement of dysphagia
Zeitfenster: Up to 2 years
|
Up to 2 years
|
|
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Duration of improvement of dysphagia
Zeitfenster: Up to 2 years
|
Up to 2 years
|
Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Ann Mauer, University of Chicago Comprehensive Cancer Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
- Erkrankungen des Verdauungssystems
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen nach Standort
- Karzinom
- Neubildungen, Drüsen und Epithelien
- Gastrointestinale Neubildungen
- Neoplasmen des Verdauungssystems
- Magen-Darm-Erkrankungen
- Kopf-Hals-Neubildungen
- Erkrankungen der Speiseröhre
- Adenokarzinom
- Ösophagusneoplasmen
- Antineoplastische Mittel
- Cisplatin
Andere Studien-ID-Nummern
- NCI-2012-02576 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))
- N01CM62201 (US NIH Stipendium/Vertrag)
- CDR0000352307
- UCCRC-12765A
- NCI-6285
- 12765A (Andere Kennung: University of Chicago Comprehensive Cancer Center)
- 6285 (Andere Kennung: CTEP)
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