- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Iowa
-
Sioux City, Iowa, Forente stater, 51101
- Siouxland Hematology-Oncology Associates, LLP
-
Sioux City, Iowa, Forente stater, 51104
- St. Luke's Regional Medical Center
-
Sioux City, Iowa, Forente stater, 51104
- Mercy Medical Center - Sioux City
-
-
South Dakota
-
Sioux Falls, South Dakota, Forente stater, 57105
- Avera Cancer Institute
-
Sioux Falls, South Dakota, Forente stater, 57105
- Medical X-Ray Center, PC
-
Sioux Falls, South Dakota, Forente stater, 57117-5039
- Sanford Cancer Center at Sanford USD Medical Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Objective tumor response rate
Tidsramme: Up to 3 years
|
Up to 3 years
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Total overlevelse
Tidsramme: Inntil 3 år
|
Inntil 3 år
|
|
Tid til progresjon
Tidsramme: Inntil 3 år
|
Inntil 3 år
|
|
Livskvalitet
Tidsramme: Inntil 3 år
|
Inntil 3 år
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Neoplasmer i hode og nakke
- Esophageal sykdommer
- Neoplasmer i magen
- Neoplasmer i spiserøret
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Capecitabin
- Oksaliplatin
Andre studie-ID-numre
- NCCTG-N0149
- NCI-2012-02471 (Registeridentifikator: CTRP (Clinical Trials Reporting System))
- CDR0000069413 (Registeridentifikator: PDQ (Physician Data Query))
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