- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00881504
A Study of FOLFOX6 With Bevacizumab for Biliary System Carcinoma
A Single-Center, Open-Labeled, Phase II Trial of Modified FOLFOX6 With Bevacizumab in Patients With Advanced Biliary System Carcinoma
This study is for patients with biliary tract cancer that has spread and who are not candidates for surgical resection.
The purpose of this research is to determine if bevacizumab can be safely administered with Modified FOLFOX 6 and find out what effects, good and/or bad, this type of treatment has on biliary cancer.
In this study, a combination of chemotherapy, Modified FOLFOX6 and a biologic agent, bevacizumab will be tested.
Subjects on this study will receive chemotherapy and bevacizumab every 2 weeks until their disease gets worse or they are unable to tolerate treatment.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 2
Kontakter og lokationer
Studiesteder
-
-
District of Columbia
-
Washington, District of Columbia, Forenede Stater, 20007
- Georgetown University Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Histologically or cytologically confirmed diagnosis of non-resectable adenocarcinoma of the biliary tract, including carcinomas of the gallbladder, the intrahepatic or extrahepatic biliary tract, and ampullary cancer
- Measurable or evaluable disease
- Locally advanced disease that is inoperable ot patients who have had disease recurrence after curative surgical attempt
- Ambulatory with an ECOG performance status of 0-1
- Adequate organ and marrow function
- Must agree to avoid pregnancy prior to study entry and throughout the duration of study participation
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Any prior chemotherapy
- Patients who are receiving other investigational agents
- Patients who have received radiotherapy to more than 25% of their bone marrow for any reason
- Peripheral neuropathy >/= 2
- Known brain metastases, uncontrolled seizure disorder, encephalitis
- Prior history of hypertensive crisis or hypertensive encephalopathy, uncontrolled hypertension,unstable angina, congestive heart failure of New York Heart Association (NYHA) class 2 or greater, left ventricular ejection fraction less than 50%, clinically significant vascular disease, serious cardiac arrhythmia requiring medication, cardiomyopathy
- History of myocardial infarction, unstable angina or stroke/transient ischemic attack (TIA) within 6 months
- History of allergy to oxaliplatin, 5-fluoruracil (5-FU), Leucovorin, or Bevacizumab
- History of intra-abdominal abscess within 4 weeks of study entry, abdominal fistula, gastrointestinal perforation, active peptic ulcer disease, or inflammatory bowel disease
- Evidence of bleeding diathesis or coagulopathy
- Serious non-healing wound, ulcer, or bone fracture
- Major surgical procedure, open biopsy, or significant traumatic injury within 4 weeks of study entry or anticipation of need for major surgery during the course of the study
- Minor surgical procedures such as core biopsies within 7 days before enrollment, chemotherapy port placement within 24 hours
- Patients on full-dose anticoagulants who have out of range international normalized ratio (INR) or active bleeding
- Concurrent malignancy unless the subject has been curatively treated and disease free for >/= 2 years or the cancer was non-melanoma skin cancer or early cervical cancer
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
- Known HIV or Hepatitis B or C
- Life expectancy less than 12 weeks
- Pregnant or nursing women
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: "FOLFOX6" and "Bevacizumab"
Intervention = "bevacizumab" in combination with chemotherapy Treatment of biliary system carcinoma using "Bevacizumab" in combination with "modified FOLFOX6". |
Oxaliplatin 85 mg/m2 IV on Day 1 5-FU: 400 mg/m2 IV bolus on Day 1, followed by 2400 mg/M2 over 46 hours Leucovorin: 400 mg IV Day 1 Bevacizumab: 10 mg/kg IV on Day 1 Repeat cycles every 2 weeks until death, disease progression, unacceptable toxicity, patient refusal, or treatment delay > 4 weeks
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Progression-free Survival
Tidsramme: 2 years
|
Progression-free Survival is defined as the time from randomization (or study initiation) until objective tumor progression or death.
|
2 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Safety and Toxicity
Tidsramme: 8 weeks
|
The number of patients who underwent FOLFOX dose reductions as a result of Grade 3 toxicity.
|
8 weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
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 (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Neoplasmer i fordøjelsessystemet
- Galdevejssygdomme
- Galdevejsneoplasmer
- Lægemidlers fysiologiske virkninger
- Antineoplastiske midler
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Bevacizumab
Andre undersøgelses-id-numre
- OX-07-006
- 2007-411 (Anden identifikator: IRB)
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 Galdevejskræft
-
Federal University of Rio Grande do SulRekruttering
-
Maastricht University Medical CenterWingate Institute of NeurogastroenterologyRekrutteringfMRI | Transkutan Vagal Nerve Stimulation (tVNS) | Nucleus of the Solitary Tract (NTS)Holland, Det Forenede Kongerige
-
Majmaah UniversityIkke rekrutterer endnuSinus Tract | Singler besøg | Multibesøg | Enkel kegle obturationsteknik | Biokeramisk forsegler
-
Hadassah Medical OrganizationUkendtØvre Tract UreterolithiasisIsrael
-
Second Affiliated Hospital of Wenzhou Medical UniversityRekrutteringVentrikulær udstrømning Tract Ventrikulære arytmier | RadiofrekvenskateterablationKina