- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00183872
Study of Irinotecan and Docetaxel in Patients With Metastatic or Unresectable Gastric or Gastroesophageal Junction Adenocarcinoma
21. januar 2018 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
40
Fase
- Fase 2
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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California
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Los Angeles, California, Forenede Stater, 90033
- University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
-
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Arm 1 - Irinotecan and Docetaxel
Irinotecan given day 1 and 8 every 21 days Docetaxel given day 1 and 8 every 21 days
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docetaxel 30 mg/m2 IV infusion days 1 and 8, with irinotecan 65 mg/m2 IV infusion on days 1 and 8.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
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every 2 cycles
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
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every 2 cycles
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Syma Iqbal, M.D., University of Southern California (U.S.C.)/ Norris Comprehensive Cancer Center
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
14. april 2005
Primær færdiggørelse (Faktiske)
20. oktober 2014
Studieafslutning (Faktiske)
20. oktober 2015
Datoer for studieregistrering
Først indsendt
9. september 2005
Først indsendt, der opfyldte QC-kriterier
9. september 2005
Først opslået (Skøn)
16. september 2005
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
19. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. januar 2018
Sidst verificeret
1. december 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer efter sted
- Karcinom
- Neoplasmer, kirtel og epitel
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Adenocarcinom
- Esophageale neoplasmer
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Topoisomerasehæmmere
- Topoisomerase I-hæmmere
- Docetaxel
- Irinotecan
Andre undersøgelses-id-numre
- 3G-03-5
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Mavekræft
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Washington University School of MedicineNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)AfsluttetRoux-en-Y Gastric Bypass | Bariatrisk kirurgi | Vertikal ærmegatrektomi | Mavebånd | Bypass, GastricForenede Stater
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North Dakota State UniversityNeuropsychiatric Research Institute, Fargo, North DakotaAfsluttetRoux en Y Gastric BypassForenede Stater
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Rijnstate HospitalAfsluttetRoux-en-Y Gastric Bypass | Mavetømning | Bariatrisk kirurgiHolland
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Rijnstate HospitalAfsluttet
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Kliniske forsøg med irinotecan, docetaxel
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National Taiwan University HospitalFar Eastern Memorial HospitalAfsluttet
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)AfsluttetMavekræft | SpiserørskræftForenede Stater, Canada
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Eastern Cooperative Oncology GroupNational Cancer Institute (NCI)AfsluttetHoved- og halskræftForenede Stater
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Alliance for Clinical Trials in OncologyNational Cancer Institute (NCI)AfsluttetBrystkræftForenede Stater
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Memorial Sloan Kettering Cancer CenterNational Cancer Institute (NCI)Afsluttet
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Shanghai JMT-Bio Inc.Rekruttering
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Eastern Cooperative Oncology GroupNational Cancer Institute (NCI)Afsluttet
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Jiangsu HengRui Medicine Co., Ltd.RekrutteringHER2-positiv avanceret gastrisk cancer eller gastroøsofageal Junction AdenocarcinomaKina