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- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Inschrijving
Fase
- Fase 2
- Fase 1
Contacten en locaties
Studie Locaties
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California
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Los Angeles, California, Verenigde Staten, 90025
- Rosen, Lee
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Los Angeles, California, Verenigde Staten, 90089
- University of Southern California Norris Comprehensive Cancer Center
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Hawaii
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Honolulu, Hawaii, Verenigde Staten, 96817
- Chong, Clayton
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Honolulu, Hawaii, Verenigde Staten, 96817
- Straub Clinic and Hospital
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Illinois
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Chicago, Illinois, Verenigde Staten, 60637
- University of Chicago
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern University Robert H Lurie Comprehensive Cancer Center
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New Mexico
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Albuquerque, New Mexico, Verenigde Staten, 87108
- New Mexico VA Health Care System
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Albuquerque, New Mexico, Verenigde Staten, 87108
- Lovelace Sandia Health System
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Albuquerque, New Mexico, Verenigde Staten, 87131
- University of New Mexico - Albuquerque
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Pennsylvania
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Philadelphia, Pennsylvania, Verenigde Staten, 19104
- Abramson Cancer Center at the University of Pennsylvania
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Texas
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Houston, Texas, Verenigde Staten, 77030
- MD Anderson 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
- 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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie 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
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- TPU-S1101; ID02-694
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
Klinische onderzoeken op Maagkanker
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RSP Systems A/SVoltooid
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Medtronic - MITGVoltooid
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State University of New York - Upstate Medical...BeëindigdGastric Bypass-statusVerenigde Staten
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Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)IngetrokkenGastric Bypass-operatie
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Olympus Corporation of the AmericasUnity Health TorontoVoltooid
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidRoux en Y Gastric BypassVerenigde Staten
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North Dakota State UniversityNational Institutes of Health (NIH)VoltooidRoux en Y Gastric Bypass ChirurgieVerenigde Staten
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaVoltooidSleeve gastrectomie | Roux en Y Gastric BypassVerenigde Staten
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Medical University of South CarolinaVoltooidGastric Bypass Chirurgie PijnbestrijdingVerenigde Staten
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Rijnstate HospitalVoltooid
Klinische onderzoeken op cisplatine
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Centre Oscar LambretNational Cancer Institute, FranceBeëindigdPlaveiselcelcarcinoom van de slokdarmFrankrijk
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Third Military Medical UniversityOnbekendBehandeling | Diagnose stellen van ziekten | Longadenocarcinoom, stadium I | Circulerende tumorcellenChina