Fluorouracil, Oxaliplatin, and Leucovorin in Treating Patients With Metastatic Stomach Cancer or Gastroesophageal Junction Cancer
Pharmacogenomically Selected Treatment for Gastric and Gastroesophageal Junction (GEJ) Tumors: A Phase II Study
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, oxaliplatin, and leucovorin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving fluorouracil together with oxaliplatin and leucovorin works in treating patients with metastatic stomach cancer or gastroesophageal junction cancer.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
Primary
- Compare the response rate in patients with "good risk" genotype (TSER*2/*2 or TSER*2/*3 genotype [low TS expression]) to historical control response rates in non-genotype selected patients.
OUTLINE: This is a multicenter study.
Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Available tumor tissue samples are assessed for expression of TS at the mRNA and protein levels. The results are correlated with germline and tumor TSER genotypes as well as response to the study treatment regimen. Polymorphisms in other genes associated with treatment outcome or toxicity are also assessed.
After completion of study treatment, patients are followed periodically for 4 years.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
Missouri
-
St Louis, Missouri, Forente stater, 63110
- Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
-
-
North Carolina
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Chapel Hill, North Carolina, Forente stater, 27599-7295
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
-
-
Tennessee
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Nashville, Tennessee, Forente stater, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, Forente stater, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville, Tennessee, Forente stater, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
Patients must have histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Metastatic disease
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
No known active brain metastases
- Patients with treated brain metastases are eligible if stable off steroids for at least 30 days
PATIENT CHARACTERISTICS:
- ECOG performance status ≤ 2 (Karnofsky performance status ≥ 60%)
- Life expectancy ≥ 3 months
- WBC ≥ 3,000/μL
- Absolute neutrophil count ≥ 1,500/μL
- Platelets ≥ 100,000/μL
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN)
- AST or ALT ≤ 2.5 x ULN (< 5 x ULN if known liver metastases)
- Creatinine clearance ≤ 1.5 x ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 21 days after completion of study treatment
- No history of allergic reactions to fluorouracil or oxaliplatin
- No concurrent uncontrolled illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
PRIOR CONCURRENT THERAPY:
No prior therapy for metastatic disease
- Prior neoadjuvant or adjuvant therapy is allowed if the disease-free interval has been longer than 6 months
- No other concurrent chemotherapy
- No concurrent combination anti-retroviral therapy for HIV-positive patients
- No concurrent routine prophylaxis with filgrastim (G-CSF)
- No other concurrent antineoplastic agents, including chemotherapy, radiation therapy, or biologic agents
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Behandling
|
Blodsamling
Given through a vein over 5 minutes and then continuously over 46 hours on days 1 and 15.
through a vein over 2 hours on days 1 and 15.
500 ml D5W through a vein over 2 hours on days 1 and 15.
Blood collection
Blood collection
Blood collection
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number of Patients With Each Response in "Good Risk" Genotype (Thymidylate Synthase Promoter Enhancer Region [TSER]*2/*2 or TSER*2/*3 Genotype [Low TS Expression])
Tidsramme: every 8 weeks to progression
|
Per RECIST criteria v. 1.0: measurable lesions: complete response (CR) disappearance of target lesions, partial response (PR) > 30% decrease in the sum of the longest diameter (LD) of target lesions, progressive disease (PD) > 20% increase in the sum of the LD of target lesions or appearance of new lesions, stable disease (SD) neither sufficient decrease nor increase of the sum of smallest sum of the LD of target lesions.
This is a one-time assessment.
|
every 8 weeks to progression
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center
Publikasjoner og nyttige lenker
Hjelpsomme linker
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
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer
- Neoplasmer etter nettsted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Magesykdommer
- Neoplasmer i magen
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Antimetabolitter, antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Beskyttende agenter
- Mikronæringsstoffer
- Vitaminer
- Kalsiumregulerende hormoner og midler
- Motgift
- Vitamin B kompleks
- Fluorouracil
- Oksaliplatin
- Leucovorin
- Kalsium
- Levoleucovorin
Andre studie-ID-numre
- VICC GI 0716
- P30CA068485 (U.S. NIH-stipend/kontrakt)
- VU-VICC-GI-0716
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