A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma (OCEANS)
10. Juli 2017 aktualisiert von: Genentech, Inc.
A Phase III, Multicenter, Randomized, Blinded, Placebo-controlled Trial of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Platinum-sensitive Recurrent Ovary, Primary Peritoneal, or Fallopian Tube Carcinoma
This is a placebo-controlled, randomized, multicenter Phase III study that will evaluate the safety and efficacy of bevacizumab, administered in combination with carboplatin with gemcitabine, in women with platinum-sensitive recurrent epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Tatsächlich)
484
Phase
- Phase 3
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
Weiblich
Beschreibung
Inclusion Criteria:
- Signed Informed Consent Form
- Age ≥ 18 years
- Documented ovarian, primary peritoneal, or fallopian tube carcinoma that has recurred
- No prior chemotherapy in the recurrent setting
- Measurable disease
- Recovered from prior radiation therapy or surgery
Exclusion Criteria:
- Prior chemotherapy treatment for recurrent ovarian, primary peritoneal, or fallopian tube carcinoma
- History of abdominal fistula, gastrointestinal perforation (GIP), or intra-abdominal abscess
- Patients with clinical symptoms or signs of gastrointestinal (GI) obstruction or who require parenteral hydration, parenteral nutrition, or tube feeding
- Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure
- Current, recent, or planned participation in an experimental drug study
- History of systemic bevacizumab (Avastin) or other vascular endothelial growth factor (VEGF) or VEGF receptor-targeted agent use
- Inadequately controlled hypertension
- Prior history of hypertensive crisis or hypertensive encephalopathy
- New York Heart Association Class II or greater congestive heart failure (CHF)
- History of myocardial infarction or unstable angina
- History of stroke or transient ischemic attack (TIA)
- Known central nervous system (CNS) disease except for treated brain metastasis
- Significant vascular disease or recent peripheral arterial thrombosis
- History of hemoptysis
- Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation)
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Doppelt
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Experimental: Carboplatin and gemcitabine + bevacizumab
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles.
The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula.
Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles.
Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles.
The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
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Carboplatin was provided as commercially available drug.
Gemcitabine was provided as commercially available drug.
Bevacizumab was supplied as a clear to slightly opalescent, sterile liquid in glass vials (400 mg in 8 mL [25 mg/mL]) with a vehicle consisting of sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.
Andere Namen:
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Aktiver Komparator: Carboplatin and gemcitabine + placebo
Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles.
The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula.
Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles.
Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
|
Carboplatin was provided as commercially available drug.
Gemcitabine was provided as commercially available drug.
Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Zeitfenster: From randomization through September 17, 2010 (up to 3 years, 5 months)
|
PFS was defined as the time from randomization to disease progression (PD), as determined by the investigator, or death due to any cause.
PD: At least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since treatment started; the appearance of 1 or more new lesions; and/or the unequivocal progression of existing non-target lesions.
Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.
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From randomization through September 17, 2010 (up to 3 years, 5 months)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Zeitfenster: From randomization through September 17, 2010 (up to 3 years, 5 months)
|
An objective response was the occurrence of either a partial response (PR) or complete response (CR).
PR: At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter.
CR: The disappearance of all target and non-target lesions.
Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.
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From randomization through September 17, 2010 (up to 3 years, 5 months)
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Duration of Objective Response (OR) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Zeitfenster: From randomization through September 17, 2010 (up to 3 years, 5 months)
|
Duration of OR was analyzed in the subset of patients who achieved an OR.
The duration of OR was defined as the time from the initial CR or PR until documented PD or death.
Lesions were assessed by computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound every 9 weeks.
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From randomization through September 17, 2010 (up to 3 years, 5 months)
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Overall Survival
Zeitfenster: From randomization through July 19, 2013 (up to 6 years, 3 months)
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Overall survival was defined as the time from randomization to death from any cause.
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From randomization through July 19, 2013 (up to 6 years, 3 months)
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Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)
Zeitfenster: From randomization through September 17, 2010 (up to 3 years, 5 months)
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A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.
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From randomization through September 17, 2010 (up to 3 years, 5 months)
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Percentage of Patients Who Had at Least 1 Adverse Event
Zeitfenster: From randomization through July 19, 2013 (up to 6 years, 3 months)
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From randomization through July 19, 2013 (up to 6 years, 3 months)
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Sponsor
Ermittler
- Studienleiter: Amreen Husain, MD, Genentech, Inc.
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- Vaughan S, Coward JI, Bast RC Jr, Berchuck A, Berek JS, Brenton JD, Coukos G, Crum CC, Drapkin R, Etemadmoghadam D, Friedlander M, Gabra H, Kaye SB, Lord CJ, Lengyel E, Levine DA, McNeish IA, Menon U, Mills GB, Nephew KP, Oza AM, Sood AK, Stronach EA, Walczak H, Bowtell DD, Balkwill FR. Rethinking ovarian cancer: recommendations for improving outcomes. Nat Rev Cancer. 2011 Sep 23;11(10):719-25. doi: 10.1038/nrc3144.
- Aghajanian C, Goff B, Nycum LR, Wang YV, Husain A, Blank SV. Final overall survival and safety analysis of OCEANS, a phase 3 trial of chemotherapy with or without bevacizumab in patients with platinum-sensitive recurrent ovarian cancer. Gynecol Oncol. 2015 Oct;139(1):10-6. doi: 10.1016/j.ygyno.2015.08.004. Epub 2015 Aug 10.
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. April 2007
Primärer Abschluss (Tatsächlich)
1. September 2010
Studienabschluss (Tatsächlich)
1. Juli 2013
Studienanmeldedaten
Zuerst eingereicht
9. Februar 2007
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
9. Februar 2007
Zuerst gepostet (Schätzen)
13. Februar 2007
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
9. August 2017
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
10. Juli 2017
Zuletzt verifiziert
1. Juli 2017
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Neubildungen nach histologischem Typ
- Neubildungen
- Neubildungen, Drüsen und Epithelien
- Karzinom
- Physiologische Wirkungen von Arzneimitteln
- Molekulare Mechanismen der pharmakologischen Wirkung
- Antiinfektiva
- Antivirale Mittel
- Enzym-Inhibitoren
- Antimetaboliten, antineoplastisch
- Antimetaboliten
- Antineoplastische Mittel
- Immunsuppressive Mittel
- Immunologische Faktoren
- Antineoplastische Mittel, immunologische
- Angiogenese-Inhibitoren
- Angiogenese-modulierende Mittel
- Wuchsstoffe
- Wachstumshemmer
- Gemcitabin
- Carboplatin
- Bevacizumab
Andere Studien-ID-Nummern
- AVF4095g
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