Study of Bevacizumab in Combination With 5-FU, Oxaliplatin and External Beam Radiation Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
7. august 2009 opdateret af: Massachusetts General Hospital
A Tolerability and Efficacy Study of the Angiogenesis Inhibitor Bevacizumab in Combination With 5-Fluorouracil, Oxaliplatin, and External Beam Radiation Therapy Followed by Gemcitabine and Bevacizumab for Locally Advanced Pancreatic Cancer
The purpose of this study is determine the safety of bevacizumab, oxaliplatin, 5-FU, and gemcitabine in combination with external beam radiation therapy(Phase I portion) as well as to begin to collect information about whether this combination treatment is effective in treating patients with locally advanced pancreatic cancer (Phase II portion).
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
- The combination of all three drugs and radiation treatment has never been given to people before, therefore, we are going to add just one additional drug at a time for safety reasons.
- The first group of participants (3-4) who enroll on the study will receive 5-FU, radiation therapy with the added drug oxaliplatin, this is called Regimen level 1. If these participants have few or easily manageable side effects, then another group of participants will be enrolled and will receive 5-FU, radiation, oxaliplatin with the addition of bevacizumab this is called Regimen level 2.
- The combination of study drugs and radiation will last about 6 weeks, this 6 week period is called a cycle 1.
- Regimen Level 1 will receive the following: oxaliplatin intravenously on days 1, 8, 15, 22, 29, and 36; 5-FU infused by a continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38; radiation therapy Monday-Friday to complete on day 38.
- Regimen Level 2 will receive the following; bevacizumab intravenously on days 1, 15, and 29; oxaliplatin intravenously on days 1, 8, 15, 22, 29 and 36; 5-FU infused by continuous infusion days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-38; radiation therapy Monday-Friday to complete on day day 38.
- The following are tests and procedures that will be performed during cycle 1: physical examination; blood work, urine sample. perfusion CT scan on day 12 (for those participants enrolled at Massachusetts General Hospital).
- At the end of cycle 1, CT scans will be performed to evaluate the participants disease status before they receive combination gemcitabine and bevacizumab. If the scans show the tumor has reduced in size and can be surgically removed, then surgery will be scheduled and the patient will receive gemcitabine and bevacizumab about 4 weeks after the surgery. If the scans show the tumor can not be removed, the patient will receive the gemcitabine/bevacizumab combination about 4 weeks after completing cycle 1.
- Cycles 2-5 consist of: gemcitabine given intravenously on days 1, 8, and 15 every 28 days; bevacizumab given intravenously on days 1 and 15 every 28 days. During cycles 2-5 the following tests and procedures will be performed: physical examination including vital signs on day 1 and 15 of each cycle; blood work on days 1, 8 and 15 of each cycle; a urine sample on day 1 of each cycle; CT scans will be done every 2 cycles.
- It will take about 7 months to complete the study treatment (longer for those who have surgery after Cycle 1).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
52
Fase
- Fase 2
- Fase 1
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:
- Histologically and radiologically confirmed locally advanced pancreatic ductal adenocarcinoma and have not received prior therapy
- Disease is measurable by CT scan
- Age >= to 18 years
- Life expectancy of 4 months or longer
- ANC >/= 1,500mm/cm3
- Hemoglobin >/= 9g/dl
- Platelet count >/= 100,000/cm3
- Total bilirubin </= 2 times control
- SGOT/SGPT </= 2.5 times upper limit of normal
- Serum creatinine < 2mg/dl
- No evidence of metastatic disease by laparoscopy
Exclusion Criteria:
- History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the subject at high risk for complications
- No secondary malignancies other than non-melanoma skin cancers or carcinoma in-situ of the cervix within past 5 years
- Patients with pre-existing peripheral neuropathy of grade 2 or greater
- Pregnant or lactating women
- Current, recent (within 4 weeks of study entry) or planned participation in an experimental drug study
- Blood pressure of >150/100 mmHg
- Unstable angina
- New York Heart Association Grade II or greater congestive heart failure
- History of myocardial infarction or stroke within 6 months
- Clinically significant peripheral vascular disease
- Evidence of bleeding diathesis or coagulopathy
- Presence of central nervous system or brain metastases
- Major surgical procedure, open biopsy,m or significant traumatic injury within 28 days prior to day 0
- Minor surgical procedures, fine needle aspirations or core biopsies within 7 days prior to day 0
- Urine protein creatinine ratio > or = to 1.0 at screening
- History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to day 0
- Serious, non-healing wound, ulcer, or bone fracture
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: Ikke-randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Regimen Level 1
Radiation/Oxaliplatin/5-FU
|
Intravenously on days 1, 15 and 29 of the first cycle.
Intravenously on days 1, 15 of each 28-day cycles for cycles 2-5.
Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
Monday through Friday ending on day 38 of cycle 1
|
|
Eksperimentel: Regimen Level 2
Radiation/Oxaliplatin/Bevacizumab/5-FU
|
Intravenously on days 1, 15 and 29 of the first cycle.
Intravenously on days 1, 15 of each 28-day cycles for cycles 2-5.
Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
Monday through Friday ending on day 38 of cycle 1
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To determine the safety and tolerability of the combination of bevacizumab, 5-FU, oxaliplatin, and EBRT for locally advanced pancreatic cancer
Tidsramme: 2 years
|
2 years
|
|
to determine the survival of patients treated with this regimen.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
To determine the progression free survival
|
|
|
to determine the rate of conversion to resectability after treatment
Tidsramme: 2 years
|
2 years
|
|
to asses the duration of response and response rate of this combination and
|
|
|
to evaluate the toxicities.
Tidsramme: 2 years
|
2 years
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital
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
1. maj 2006
Primær færdiggørelse (Faktiske)
1. august 2007
Studieafslutning (Faktiske)
1. juli 2009
Datoer for studieregistrering
Først indsendt
24. marts 2006
Først indsendt, der opfyldte QC-kriterier
24. marts 2006
Først opslået (Skøn)
28. marts 2006
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
10. august 2009
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
7. august 2009
Sidst verificeret
1. august 2009
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Sygdomme i fordøjelsessystemet
- Neoplasmer
- Neoplasmer efter sted
- Sygdomme i det endokrine system
- Neoplasmer i fordøjelsessystemet
- Neoplasmer i endokrine kirtler
- Pancreassygdomme
- Bugspytkirtel neoplasmer
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-infektionsmidler
- Antivirale midler
- Enzymhæmmere
- Antimetabolitter, Antineoplastisk
- Antimetabolitter
- Antineoplastiske midler
- Immunsuppressive midler
- Immunologiske faktorer
- Antineoplastiske midler, immunologiske
- Angiogenese-hæmmere
- Angiogenesemodulerende midler
- Vækststoffer
- Væksthæmmere
- Gemcitabin
- Fluorouracil
- Oxaliplatin
- Bevacizumab
Andre undersøgelses-id-numre
- 05-233
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