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- Klinische proef 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
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60637-1470
- University of Chicago Comprehensive Cancer Center
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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IV gegeven
IV gegeven
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Complete response rate
Tijdsspanne: Up to 2 years
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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)
Tijdsspanne: Up to 2 years
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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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Algemeen overleven
Tijdsspanne: Tot 2 jaar
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Kaplan-Meier-schattingen zullen worden bepaald.
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Tot 2 jaar
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Progression-free survival
Tijdsspanne: 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
Tijdsspanne: 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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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
Tijdsspanne: Up to 2 years
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Up to 2 years
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Number of patients with improvement of dysphagia
Tijdsspanne: Up to 2 years
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Up to 2 years
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Duration of improvement of dysphagia
Tijdsspanne: Up to 2 years
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Up to 2 years
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Ann Mauer, University of Chicago Comprehensive Cancer Center
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het spijsverteringsstelsel
- Neoplasmata per histologisch type
- Neoplasmata
- Neoplasmata per site
- Carcinoom
- Neoplasmata, glandulair en epitheel
- Gastro-intestinale neoplasmata
- Neoplasmata van het spijsverteringsstelsel
- Gastro-intestinale aandoeningen
- Hoofd- en nekneoplasmata
- Slokdarmaandoeningen
- Adenocarcinoom
- Slokdarmneoplasmata
- Antineoplastische middelen
- Cisplatine
Andere studie-ID-nummers
- NCI-2012-02576 (Register-ID: CTRP (Clinical Trial Reporting Program))
- N01CM62201 (Subsidie/contract van de Amerikaanse NIH)
- CDR0000352307
- UCCRC-12765A
- NCI-6285
- 12765A (Andere identificatie: University of Chicago Comprehensive Cancer Center)
- 6285 (Andere identificatie: CTEP)
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