- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00072787
Phase 1/2 Study of S-1 and Cisplatin in Advanced Gastric Cancer
A Phase I/II, Open-Label, Nonrandomized, Dose-Finding Safety, Tolerance, Pharmacokinetic, and Efficacy Study of Orally Administered S-1 in Combination With Cisplatin in Patients With Advanced Gastric Cancer
The purpose of the phase 1 portion of the study is to determine the safe dose of S-1 and cisplatin that can be administered in gastric cancer patients.
The purpose of the phase 2 portion of the study is to determine the antitumor activity of the S-1 and cisplatin regimen established from phase 1 in patients with advanced gastric cancer.
Studieoversikt
Detaljert beskrivelse
S-1 is an oral fluoropyrimidine which combines tegafur (a 5-FU prodrug) with two classes of modulators which:
- inhibit dihydropyrimidine dehydrogenase (DPD) and
- block phosphorylation of 5-FU in gastrointestinal tissues.
S-1 is designed to enhance the the clinical utility of an oral fluoropyrimidine while ameliorating the disadvantage of gastrointestinal toxicity.
5-Fu and cisplatin have been used as a standard treatment in gastric cancer and preliminary data indicate that S-1 plus cisplatin may result in superior tolerability and efficacy in advanced gastric cancer.
S-1 is currently approved in Japan for treatment of gastric cancer and head and neck cancer.
Studietype
Registrering
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90025
- Rosen, Lee
-
Los Angeles, California, Forente stater, 90089
- University of Southern California Norris Comprehensive Cancer Center
-
-
Hawaii
-
Honolulu, Hawaii, Forente stater, 96817
- Chong, Clayton
-
Honolulu, Hawaii, Forente stater, 96817
- Straub Clinic and Hospital
-
-
Illinois
-
Chicago, Illinois, Forente stater, 60637
- University of Chicago
-
Chicago, Illinois, Forente stater, 60611
- Northwestern University Robert H Lurie Comprehensive Cancer Center
-
-
New Mexico
-
Albuquerque, New Mexico, Forente stater, 87108
- New Mexico VA Health Care System
-
Albuquerque, New Mexico, Forente stater, 87108
- Lovelace Sandia Health System
-
Albuquerque, New Mexico, Forente stater, 87131
- University of New Mexico - Albuquerque
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Abramson Cancer Center at the University of Pennsylvania
-
-
Texas
-
Houston, Texas, Forente stater, 77030
- MD Anderson Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria
- Has histologically or cytologically confirmed adenocarcinoma of the stomach or gastroesophageal junction
- Has advanced, unresectable cancer at the time of study entry
- Has measurable disease as defined by RECIST criteria, i.e., lesions that can be accurately measured in at least one dimension with the longest diameter ≥20 mm using conventional techniques or ≥10 mm using spiral CT scan
- Is at least 3 weeks post-gastrectomy surgery
- Has not received prior chemotherapy for their cancer (adjuvant therapy is permitted and does not count as prior chemotherapy).
- Has performance status of ≥ 70% on the Karnofsky scale (Appendix B)
- Has a predicted life expectancy of ≥ 12 weeks
- Has an absolute granulocyte count of ≥ 1,500/mm3
- Has a platelet count ≥ 100,000/mm3
- Has a hemoglobin of ≥ 9.0 g/dL
- Has a bilirubin of ≤ 1.5 times the ULN
- Has transaminases ≤ 2.5 times the ULN except for patients with liver metastasis who may have transaminases ≤ 5 times the ULN
- Has a creatinine ≤ ULN and calculated creatinine ≥ 60 mL/min
- According to the judgment of the Investigator, the patient has recovered from all previous anti-cancer treatment-related toxicities to at least Grade 1 (see exceptions above)
- Has stopped all previous investigational drugs at least 4 weeks prior to treatment with S-1 and cisplatin.
- Is able to take medications orally
- Female patients of childbearing potential who are not pregnant and who use acceptable means of contraception while on study and for an additional 30 days after the last dose of study medication. Male patients must use adequate contraception.
Exclusion Criteria
- Has relapsed within 6 months from the end of adjuvant therapy
- Has known brain or leptomeningeal metastases.
Has any other serious illness or medical condition(s) including, but not limited to, the following:
- uncontrolled congestive heart failure, angina pectoris, arrhythmias, or hypertension ; or any significant medical condition that is a contraindication for chemotherapy
- concurrent malignancy other than gastric cancer except adequately treated carcinoma-in-situ of the cervix or non-melanoma skin cancer
- active infection
- gastrointestinal disorder, including malabsorption, chronic nausea and vomiting, chronic diarrhea
- unstable diabetes mellitus
- psychiatric disorder that may interfere with consent and/or protocol compliance
- known neuropathy (including hearing loss) at baseline of Grade 2 or higher (as per NCI CTC v2.0 see Appendix A)
- Has known hypersensitivity to any of the constituents of the study medication
- Is receiving a concomitant treatment with drugs interacting with S-1.
- Is a pregnant or lactating female or who refuses to use an acceptable means of contraception. Is a male and refuses to use an acceptable means of contraception.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Samarbeidspartnere og etterforskere
Sponsor
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
Andre studie-ID-numre
- TPU-S1101; ID02-694
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
Kliniske studier på Magekreft
-
Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)FullførtRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertical Sleeve Gastrectomy | Magebånd | Bypass, GastricForente stater
-
Medtronic - MITGFullført
-
North Dakota State UniversityNational Institutes of Health (NIH)FullførtRoux en Y Gastric Bypass kirurgiForente stater
-
DuomedAktiv, ikke rekrutterendeOvervekt | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgia
-
Olympus Corporation of the AmericasUnity Health TorontoFullført
-
Wageningen UniversityRijnstate HospitalUkjentRoux-en-Y Gastric BypassNederland
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaFullførtRoux en Y Gastric BypassForente stater
-
Rijnstate HospitalFullførtRoux-en-Y Gastric Bypass | Magetømming | Bariatrisk kirurgiNederland
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaFullførtSleeve Gastrectomy | Roux en Y Gastric BypassForente stater
-
Rijnstate HospitalFullførtBariatrisk kirurgi | Jern absorpsjon | Roux- en -y Gastric BypassNederland
Kliniske studier på cisplatin
-
West China Second University HospitalRekrutteringNeoadjuvant kjemoterapi | Epitelkarsinom, ovarieKina
-
Insmed IncorporatedFullførtOsteosarkom MetastatiskForente stater
-
Cedars-Sinai Medical CenterRekrutteringHPV-positivt orofaryngealt plateepitelkarsinomForente stater
-
Privo TechnologiesNational Cancer Institute (NCI)FullførtOral plateepitelkarsinomForente stater
-
Lawson Health Research InstituteRekrutteringLokalt avansert hode- og nakkeplateepitelkarsinomCanada
-
Sun Yat-sen UniversityAktiv, ikke rekrutterendeNasofaryngealt karsinomKina
-
Taiho Oncology, Inc.Quintiles, Inc.Fullført
-
Fujian Cancer HospitalHar ikke rekruttert ennå
-
Sun Yat-sen UniversityFirst Affiliated Hospital, Sun Yat-Sen University; Guangdong Provincial... og andre samarbeidspartnereAktiv, ikke rekrutterendeNasofaryngealt karsinom | Nasofaryngeale neoplasmer | Nasofaryngeale sykdommer | Neoplasma i hode og nakkeKina
-
University of VermontJohnson & JohnsonRekruttering