- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00040859
Oxaliplatin and Capecitabine in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
A Phase II Study of Oxaliplatin and Capecitabine in Patients With Measurable Metastatic Adenocarcinoma of the Esophagus, Gastroesophageal Junction, and Gastric Cardia
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining oxaliplatin with capecitabine in treating patients who have advanced esophageal cancer or stomach cancer.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OBJECTIVES:
Primary
- Determine the objective tumor response rate of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia treated with oxaliplatin and capecitabine.
Secondary
- Determine the time to progression and overall survival of patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Assess the quality of life of patients treated with this regimen.
OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR.
Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy).
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Iowa
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Sioux City, Iowa, Forenede Stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
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Sioux City, Iowa, Forenede Stater, 51104
- St. Luke's Regional Medical Center
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Sioux City, Iowa, Forenede Stater, 51104
- Mercy Medical Center - Sioux City
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Avera Cancer Institute
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Sioux Falls, South Dakota, Forenede Stater, 57105
- Medical X-Ray Center, PC
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Sioux Falls, South Dakota, Forenede Stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed adenocarcinoma of the esophagus, gastroesophageal junction, or gastric cardia for which no potentially curative or significant palliative therapy exists
- Unresectable disease
- Gastric cardia is defined as no more than 5 cm from the gastroesophageal junction into the stomach
- Measurable disease
- No known CNS metastases
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than upper limit of normal (ULN)
- AST no greater than 3 times ULN
- Alkaline phosphatase no greater than 2 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
- Creatinine clearance at least 60 mL/min
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Other:
- Able to swallow capecitabine
- No unresolved gastrointestinal bleeding
- No uncontrolled infection
- No chronic debilitating disease
- No peripheral neuropathy grade 2 or greater
- No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinoma
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No prior immunotherapy or biological therapy for recurrent or metastatic disease
- No concurrent biologic agents
Chemotherapy:
- No prior chemotherapy for recurrent or metastatic disease
- Prior adjuvant or neoadjuvant chemotherapy (including combination chemotherapy and radiotherapy) allowed
- No other concurrent chemotherapy
Endocrine therapy:
- Not specified
Radiotherapy:
- See Chemotherapy
- No prior radiotherapy for recurrent or metastatic disease
- No prior radiotherapy to more than 25% of the bone marrow
- Prior adjuvant or neoadjuvant radiotherapy allowed
- More than 4 weeks since prior radiotherapy
- No concurrent radiotherapy
Surgery:
- More than 4 weeks since prior abdominal exploration with surgical resection
- More than 3 weeks since prior abdominal exploration without surgical resection
Other:
- No concurrent oral cryotherapy during oxaliplatin administration
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: oxaliplatin + capecitabine
Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on days 1-14. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with complete response (CR) receive 2 additional courses after CR. Quality of life is assessed at baseline and then every 3 weeks (prior to each course of chemotherapy). Patients are followed every 3 months for 1 year and then every 6 months for 2 years. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Objective tumor response rate
Tidsramme: Up to 3 years
|
Up to 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
---|---|
Samlet overlevelse
Tidsramme: Op til 3 år
|
Op til 3 år
|
Tid til progression
Tidsramme: Op til 3 år
|
Op til 3 år
|
Livskvalitet
Tidsramme: Op til 3 år
|
Op til 3 år
|
Samarbejdspartnere og efterforskere
Samarbejdspartnere
Publikationer og nyttige links
Generelle publikationer
- Jatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. doi: 10.3892/ijo_00000535.
- Jatoi A, Murphy BR, Foster NR, Nikcevich DA, Alberts SR, Knost JA, Fitch TR, Rowland KM Jr; North Central Cancer Treatment Group. Oxaliplatin and capecitabine in patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction and gastric cardia: a phase II study from the North Central Cancer Treatment Group. Ann Oncol. 2006 Jan;17(1):29-34. doi: 10.1093/annonc/mdj063. Epub 2005 Nov 22.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Mavesygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Neoplasmer i maven
- Esophageale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Capecitabin
- Oxaliplatin
Andre undersøgelses-id-numre
- NCCTG-N0149
- NCI-2012-02471 (Registry Identifier: CTRP (Clinical Trials Reporting System))
- CDR0000069413 (Registry Identifier: PDQ (Physician Data Query))
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Mavekræft
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Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal ærmegatrektomi | Mavebånd | Bypass, GastricForenede Stater
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Medtronic - MITGAfsluttet
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DuomedAktiv, ikke rekrutterendeFedme | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgien
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Olympus Corporation of the AmericasUnity Health TorontoAfsluttet
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North Dakota State UniversityNational Institutes of Health (NIH)AfsluttetRoux en Y Gastric Bypass OperationForenede Stater
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Rijnstate HospitalAfsluttetRoux-en-Y Gastric Bypass | Mavetømning | Bariatrisk kirurgiHolland
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Wageningen UniversityRijnstate HospitalUkendtRoux-en-Y Gastric BypassHolland
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetRoux en Y Gastric BypassForenede Stater
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Rijnstate HospitalAfsluttet
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetSleeve Gastrectomy | Roux en Y Gastric BypassForenede Stater
Kliniske forsøg med oxaliplatin
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Xijing HospitalUkendt
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Lin ChenUkendtGastrisk AdenocarcinomKina
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University of California, DavisNational Cancer Institute (NCI)AfsluttetStadie IV brystkræftForenede Stater
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University of ChicagoNational Cancer Institute (NCI)AfsluttetBlærekræft | Overgangscellekræft i nyrebækkenet og urinlederenForenede Stater, Canada
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Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetEndometriecancerForenede Stater
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European Organisation for Research and Treatment...AfsluttetBrystkræftFrankrig, Belgien, Slovenien, Israel, Det Forenede Kongerige, Tyskland, Østrig
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Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetLivmoderhalskræft | Primær peritoneal kræftForenede Stater, Canada
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Gynecologic Oncology GroupNational Cancer Institute (NCI)AfsluttetLivmoderhalskræftForenede Stater, Canada
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Ohio State University Comprehensive Cancer CenterNational Cancer Institute (NCI)AfsluttetHoved- og halskræftForenede Stater
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St. Jude Children's Research HospitalNational Cancer Institute (NCI)AfsluttetUspecificeret fast tumor i barndommen, protokolspecifikForenede Stater