- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00183872
Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
21. januar 2018 oppdatert av: University of Southern California
Phase II Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
This study is for people with advanced gastric or gastroesophageal cancer.
This study is being done to find out how long it takes tumors to grow after receiving treatment with the drugs irinotecan (also known as CPT-11) and docetaxel (also known as Taxotere).
Irinotecan is a drug that has been approved by the Food and Drug Administration (FDA).
Irinotecan has been approved for treatment of cancer of the colon and rectum.
Docetaxel is another drug approved by the FDA.
Docetaxel is approved for treatment of breast, prostate and lung cancer.
However, the FDA has authorized the use of irinotecan and docetaxel in this study.
This study will evaluate the effects of these drugs on participant's tumors.
The side effects of the combination of irinotecan and docetaxel will also be evaluated.
This study will also measure the levels of certain substances in participant's tumors.
These substances, called genes (which are the cell's blueprint), affect how people's bodies react to the cancer drugs.
Genes will also be measured in participant's blood.
The researchers want to see if these substances can predict response to the study drugs.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
40
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
California
-
Los Angeles, California, Forente stater, 90033
- University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Patients must have clinically documented unresectable or metastatic gastric cancer or gastroesophageal adenocarcinoma and histologic confirmation of the diagnosis with tumor.
- Patients must have received one prior chemotherapeutic regimen for metastatic or unresectable disease. Patients may not have received prior therapy with irinotecan or a taxane.
- Tissue from tumor must be available. This may be paraffin embedded tissue from previous biopsy/resection or if it is not available, a repeat biopsy must be performed.
- Patients must agree to have a 20 cc blood sample drawn in addition to routine labs with each cycle of chemotherapy.
- Patients must have measurable disease by clinical exam or radiologic studies, that is at least one lesion measurable in at least one dimension, measuring 10 mm or more on a spiral CT scan, or at least 20 mm by an exam or a non-spiral scan. If prior radiation therapy was administered, measurable disease must be outside the radiation field.
- Patients must have a Zubrod performance status of 0-2.
- Patients must have a predicted life expectancy of at least 12 weeks.
Patients must have:
- a pre-treatment granulocyte count (i.e., segmented neutrophils + bands) of >1,500/mm3,
- a hemoglobin level of greater than or equal to 9.0 gm/dl, and
- a platelet count of >100,000/mm3.
- Patients must have adequate renal function as documented by a calculated creatinine clearance > 60.
- Patients must have adequate hepatic function as documented by a serum bilirubin less than or equal to the institutional upper limit of normal, regardless of whether patients have liver involvement secondary to tumor.
- No major surgery within 1 month of starting study drug.
- Women of childbearing potential must have a negative pregnancy test.
- Peripheral neuropathy: must be < grade 1
Exclusion Criteria:
- Patients may not have a history of an allergy to irinotecan.
- Patients with any active or uncontrolled infection, including known HIV infection.
- Patients with psychiatric disorders that would interfere with consent or follow-up.
- Patients with a history of myocardial infarction within the previous six months or congestive heart failure requiring therapy.
- Pregnant or lactating women. Men and women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method while on treatment and for at least 3 months thereafter.
- Presence of clinically apparent central nervous system metastases or carcinomatous meningitis.
- Patients with a history of seizures are ineligible. Patients receiving phenytoin, phenobarbital, or other anti-epileptic prophylaxis are ineligible.
- Patients with any other severe concurrent disease, which in the judgment of the investigator would make the patient inappropriate for entry into this study.
- Patients with a history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
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: Arm 1 - Irinotecan and Docetaxel
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
|
docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Objective Response (Complete, Partial, Stable and Progression)
Tidsramme: every 2 cycles
|
Objective response was defined using standard RECIST criteria.
CR (complete response) = disappearance of all target lesions; PR (partial response) = 30% decrease in the sum of the longest diameter or target lesions; PD (progressive disease) = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet criteria of CR, PR, and PD.
|
every 2 cycles
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Progression Free Survival
Tidsramme: every 2 cycles
|
Progression free survival is measured from the start of treatment until the time the participant is first recorded as having disease progression, or death due to any cause.
If a participant has not progressed or died, progression free survival is censored at the time of the last follow up.
|
every 2 cycles
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Syma Iqbal, M.D., University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
14. april 2005
Primær fullføring (Faktiske)
20. oktober 2014
Studiet fullført (Faktiske)
20. oktober 2015
Datoer for studieregistrering
Først innsendt
9. september 2005
Først innsendt som oppfylte QC-kriteriene
9. september 2005
Først lagt ut (Anslag)
16. september 2005
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
19. februar 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. januar 2018
Sist bekreftet
1. desember 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i fordøyelsessystemet
- Neoplasmer etter histologisk type
- Neoplasmer
- Neoplasmer etter nettsted
- Karsinom
- Neoplasmer, kjertel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Neoplasmer i hode og nakke
- Esophageal sykdommer
- Adenokarsinom
- Neoplasmer i spiserøret
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Topoisomerasehemmere
- Topoisomerase I-hemmere
- Docetaxel
- Irinotekan
Andre studie-ID-numre
- 3G-03-5
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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
-
Wageningen UniversityRijnstate HospitalUkjentRoux-en-Y Gastric BypassNederland
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaFullførtRoux en Y Gastric BypassForente stater
-
DuomedAktiv, ikke rekrutterendeOvervekt | Gastrectomi | Roux-en-Y Gastric Bypass | Mini Gastric BypassBelgia
-
North Dakota State UniversityNational Institutes of Health (NIH)FullførtRoux en Y Gastric Bypass kirurgiForente stater
-
Olympus Corporation of the AmericasUnity Health TorontoFullført
-
North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaFullførtSleeve Gastrectomy | Roux en Y Gastric BypassForente stater
-
Rijnstate HospitalFullførtRoux-en-Y Gastric Bypass | Magetømming | Bariatrisk kirurgiNederland
-
Rijnstate HospitalFullførtBariatrisk kirurgi | Jern absorpsjon | Roux- en -y Gastric BypassNederland
Kliniske studier på irinotecan, docetaxel
-
National Taiwan University HospitalFar Eastern Memorial HospitalFullført
-
Shanghai JMT-Bio Inc.Rekruttering
-
Jiangsu HengRui Medicine Co., Ltd.RekrutteringHER2-positiv avansert gastrisk kreft eller gastroøsofageal Junction AdenocarcinomaKina
-
Shanghai Zhangjiang Biotechnology Limited CompanyShanghai Biomabs Pharmaceutical Co., Ltd.FullførtMetastatisk tykktarmskreft
-
Centre Oscar LambretSFCEFullført
-
Tongji UniversityUkjentIkke-småcellet lungekreftKina
-
Arbeitsgemeinschaft medikamentoese TumortherapieSanofi; Pfizer; Roche Pharma AGFullført
-
Georgetown UniversityAvsluttetMagekreft | Kreft i spiserøretForente stater
-
Fudan UniversityHar ikke rekruttert ennåSmåcellet lungekreft TilbakevendendeKina
-
Boston Scientific CorporationBiocompatibles UK LtdFullførtMetastatisk tykktarmskreftStorbritannia, Østerrike, Frankrike