- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00730353
Sutent + Taxol for Advanced Esophageal Cancer
A Phase II Study of Sunitinib Malate (Sutent®) With Paclitaxel (Taxol®) in Patients With Advanced Esophageal Cancer
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
OUTLINE: This is a multi-center study.
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
- Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
- Sunitinib malate 37.5 mg orally, daily.
After 4 cycles, paclitaxel will be discontinued and patients will continue on sunitinib malate until disease progression, unacceptable toxicity, or physician discretion.
Performance Status: ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2
Life expectancy: Not specified
Hematopoietic:
- International Normalized Ratio (INR) < 1.2
- Partial Thromboplastin Time (PTT) < 1.5 x Upper Limit of Normal (ULN)
- Platelets > 100 K/mm3
- Hemoglobin > 8 g/dL
- Absolute Neutrophil Count (ANC) > 1.0 K/mm3
Hepatic:
- Aspartate transaminase (AST) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.
- Alanine transaminase (ALT) ≤ 2.5 x ULN, or ≤ 5.0 x ULN if the transaminase elevation is due to known liver metastases.
- Total bilirubin < 2.0 x ULN
Renal:
- Serum creatinine ≤ 2 x ULN or a calculated creatinine clearance (using Cockcroft-Gault formula) > 50 cc/min
Cardiovascular:
- No history of unstable angina, myocardial infarction, coronary artery bypass grafting surgery within 12 months prior to registration for protocol therapy. Patients may be on anti-anginal medications, but must be stable on those medications for at least 6 months.
- No history of New York Heart Association class II or greater congestive heart failure.
Pulmonary:
- Not specified
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University Feinberg School of Medicine
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Chicago, Illinois, Forenede Stater, 60612
- Rush-Presbyterian St. Luke's Medical Center
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Galesburg, Illinois, Forenede Stater, 61401
- Medical & Surgical Specialists, LLC
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Indiana
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Bloomington, Indiana, Forenede Stater, 47403
- Cancer Care Center of Southern Indiana
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Evansville, Indiana, Forenede Stater, 47714
- Oncology Hematology Associates of SW Indiana
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Fort Wayne, Indiana, Forenede Stater, 46815
- Fort Wayne Oncology & Hematology, Inc
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University Simon Cancer Center
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Indianapolis, Indiana, Forenede Stater, 46202
- IN Onc/Hem Associates
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Lafayette, Indiana, Forenede Stater, 47905
- Horizon Oncology Center
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Lafayette, Indiana, Forenede Stater, 47904
- Arnett Cancer Care
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Muncie, Indiana, Forenede Stater, 47303
- Medical Consultants, P.C.
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Munster, Indiana, Forenede Stater, 46321
- Monroe Medical Associates
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South Bend, Indiana, Forenede Stater, 46601
- Northern Indiana Cancer Research Consortium
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Terre Haute, Indiana, Forenede Stater, 47802
- Providence Medical Group
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Ohio
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Cleveland, Ohio, Forenede Stater, 44106
- Ireland Cancer Center - University Hospitals of Cleveland
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically confirmed recurrent or metastatic esophageal or gastro-esophageal junction squamous cell or adenocarcinoma
- Measurable or evaluable disease per RECIST within 28 days prior to being registered on protocol therapy.
- No more than one prior chemotherapy regimen for locally advanced or metastatic disease is allowed.
- Written informed consent and HIPAA authorization for release of personal health information. NOTE: HIPAA authorization may be included in the informed consent or obtained separately.
- Age > 18 years.
- Females of childbearing potential and males must be willing to use an effective method of contraception (hormonal or barrier method of birth control; abstinence) while on treatment and for 3 month period thereafter.
- Females of childbearing potential must have a negative pregnancy test within 7 days prior to being registered for protocol therapy. Subjects are considered not of child bearing potential if they are surgically sterile (they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
- Females must not be breastfeeding.
- Must be willing to comply with study and follow up procedures.
Exclusion Criteria:
- No history of inadequately controlled hypertension (Systolic Blood Pressure > 150 or Diastolic Blood Pressure > 100) on a standard regimen of antihypertensive therapy.
- No prior treatment with vascular endothelial growth factor (VEGF) inhibitor, epidermal growth factor receptor (EGFR) inhibitor, or other anti-angiogenic agent.
No serious, non-healing wound, ulcer, or bone fracture.
- No history of or current hemoptysis.
- No history of transient ischemic attack (TIA) or stroke within 12 months prior to registration for protocol therapy.
- No evidence of bleeding diathesis, coagulopathy, prolonged INR or PTT.
- No chronic anti-coagulation treatment.
- No history of central nervous system or brain metastases.
- No history of any major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to registration for protocol therapy, or anticipation of need for major surgical procedure during the course of protocol therapy.
- No history of any minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to registration for protocol therapy.
- No history of clinically significant peripheral neuropathy, i.e., Grade > 3 neuromotor or neurosensory toxicity as defined by NCI CTCAE v 3.0.
- No known history of adrenal insufficiency documented by adrenocorticotropic hormone (ACTH) stimulation testing.
- No prolonged corrected QT (QTc) interval on pre-entry electrocardiogram (> 450 msec), obtained within 28 days prior to being registered for protocol therapy.
- No other active cancers
- No clinically significant infections as judged by the treating investigator.
- No history of a seizure disorder.
- No known history of hypersensitivity to paclitaxel.
- No CYP3A4 inducers and inhibitors allowed within 14 days prior to registration on protocol therapy and while receiving the protocol therapy.
Studieplan
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: 1
Treatment will be administered on an outpatient basis. Chemotherapy will be administered in a 28-day treatment cycle. The 28 days of treatment with paclitaxel and sunitinib malate (plus the time required to recover if toxicity is encountered) is defined as a cycle.
|
Sunitinib malate 37.5 mg orally, daily
Paclitaxel 90 mg/m2 IV on days 1, 8 and 15.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression Free Survival Rate at 24 Weeks
Tidsramme: 24 weeks
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To determine the rate of non-progressive disease at 24 weeks from the first dose of the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma, where progression is defined as at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions
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24 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Response Rate
Tidsramme: 6 months
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To determine the response rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
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6 months
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Overall Survival
Tidsramme: 12 months
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To determine the one year overall survival rate for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma
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12 months
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Progression-Free Survival
Tidsramme: 12 months
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To determine the time to progression for the combination of sunitinib malate and paclitaxel in advanced esophageal carcinoma per RECIST criteria.
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12 months
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Toxicity Profile
Tidsramme: 16 months
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Determine the most frequent toxicities associated with the treatment regimen, per the CTCAE version 3 (Common Toxicity Criteria for Adverse Events) criteria.
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16 months
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Gastrointestinale neoplasmer
- Neoplasmer i fordøjelsessystemet
- Gastrointestinale sygdomme
- Neoplasmer i hoved og hals
- Esophageale sygdomme
- Esophageale neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitose modulatorer
- Antineoplastiske midler, fytogene
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Proteinkinasehæmmere
- Paclitaxel
- Sunitinib
Andre undersøgelses-id-numre
- HOG GI06-112
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Spiserørskræft
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Mayo ClinicAfsluttetEsophageal Dilatation | Refraktær benign esophageal forsnævringForenede Stater
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Case Comprehensive Cancer CenterNational Cancer Institute (NCI)AfsluttetStadium IIIA Esophageal Adenocarcinom | Stadium IIIB Esophageal Adenocarcinom | Stadie IIIC Esophageal Adenocarcinom | Stadium IIB Esophageal Adenocarcinom | Stadium IB Esophageal Adenocarcinom | Stadie IIA Esophageal AdenocarcinomForenede Stater
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University Medical Center GroningenAfsluttet
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The Cleveland ClinicMedtronic - MITGAfsluttetEsophageal læsionForenede Stater
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NYU Langone HealthTrukket tilbage
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Mayo ClinicAfsluttetAchalasia | Esophageal Achalasia | Achalasia, esophagealForenede Stater
Kliniske forsøg med Sunitinib malate
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PfizerAfsluttetGastrointestinale stromale tumorerKorea, Republikken
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PfizerAfsluttetGastrointestinale stromale tumorerForenede Stater, Tjekkiet, Frankrig
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Icahn School of Medicine at Mount SinaiPfizerAfsluttet
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California Pacific Medical Center Research InstitutePfizer; University of California, San FranciscoAfsluttet
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National Cancer Institute (NCI)AfsluttetStadie I Myelom | Stadie II Myelom | Stadium III Myelom | Refraktær MyelomForenede Stater
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National Cancer Institute (NCI)AfsluttetTilbagevendende malignt mesotheliom | Avanceret malignt mesotheliomCanada
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National Cancer Institute (NCI)AfsluttetStadie IV Ovarieepitelkræft | Tilbagevendende ovarieepitelkræft | Tilbagevendende primær peritonealhulekræft | Fase IV Primær peritonealhulekræft | Tilbagevendende æggelederkræft | Stadie IIIA Æggelederkræft | Stadie IIIB Æggelederkræft | Stadie IIIC Æggelederkræft | Stadie IV Æggelederkræft | Stadie IIIA... og andre forholdCanada
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National Cancer Institute (NCI)AfsluttetMyelodysplastiske syndromer | Kronisk myelomonocytisk leukæmi | Sekundære myelodysplastiske syndromer | de Novo Myelodysplastiske SyndromerCanada, Forenede Stater
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National Cancer Institute (NCI)Gynecologic Oncology GroupAfsluttetTilbagevendende uterin sarkom | Uterin leiomyosarkomForenede Stater
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Case Comprehensive Cancer CenterAfsluttetKlarcellet nyrecellekarcinom | Stadie IV nyrecellekræftForenede Stater