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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 aktualisiert von: 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).

Studienübersicht

Status

Beendet

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

  • 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).

Studientyp

Interventionell

Einschreibung (Tatsächlich)

52

Phase

  • Phase 2
  • Phase 1

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Nicht randomisiert
  • Interventionsmodell: Fakultätszuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Regimen Level 1
Radiation/Oxaliplatin/5-FU
Arzneimittel: bevacizumab
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.
Arzneimittel: 5-Fluorouracil
Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
Arzneimittel: Oxaliplatin
Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
Arzneimittel: gemcitabine
Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
Verfahren: External Beam Radiation Therapy
Monday through Friday ending on day 38 of cycle 1
Experimental: Regimen Level 2
Radiation/Oxaliplatin/Bevacizumab/5-FU
Arzneimittel: bevacizumab
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.
Arzneimittel: 5-Fluorouracil
Continuous infusion on days 1-5, 8-12, 15-19, 22-26, 29-33 and 36-38 of cycle one.
Arzneimittel: Oxaliplatin
Intravenously on dasy 1, 8, 15, 22, 29, 36 of cycle one.
Arzneimittel: gemcitabine
Intravenously on days 1, 8, 25 of every 28-day cycle for cycles 2-5.
Verfahren: External Beam Radiation Therapy
Monday through Friday ending on day 38 of cycle 1

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
To determine the safety and tolerability of the combination of bevacizumab, 5-FU, oxaliplatin, and EBRT for locally advanced pancreatic cancer
Zeitfenster: 2 years
2 years
to determine the survival of patients treated with this regimen.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
To determine the progression free survival
to determine the rate of conversion to resectability after treatment
Zeitfenster: 2 years
2 years
to asses the duration of response and response rate of this combination and
to evaluate the toxicities.
Zeitfenster: 2 years
2 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Massachusetts General Hospital

Mitarbeiter

Sanofi
Dana-Farber Cancer Institute
Beth Israel Deaconess Medical Center
Genentech, Inc.

Ermittler

  • Hauptermittler: Lawrence S. Blaszkowsky, MD, Massachusetts General Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Mai 2006

Primärer Abschluss (Tatsächlich)

1. August 2007

Studienabschluss (Tatsächlich)

1. Juli 2009

Studienanmeldedaten

Zuerst eingereicht

24. März 2006

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

24. März 2006

Zuerst gepostet (Schätzen)

28. März 2006

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

10. August 2009

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

7. August 2009

Zuletzt verifiziert

1. August 2009

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 05-233

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