A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma (OCEANS)
10. juli 2017 opdateret af: 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
484
Fase
- Fase 3
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
Kvinde
Beskrivelse
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)
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: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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.
Andre navne:
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Aktiv 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.
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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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Tidsramme: From randomization through September 17, 2010 (up to 3 years, 5 months)
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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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Tidsramme: From randomization through September 17, 2010 (up to 3 years, 5 months)
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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)
Tidsramme: From randomization through September 17, 2010 (up to 3 years, 5 months)
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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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studieleder: Amreen Husain, MD, Genentech, Inc.
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
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. april 2007
Primær færdiggørelse (Faktiske)
1. september 2010
Studieafslutning (Faktiske)
1. juli 2013
Datoer for studieregistrering
Først indsendt
9. februar 2007
Først indsendt, der opfyldte QC-kriterier
9. februar 2007
Først opslået (Skøn)
13. februar 2007
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
9. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
10. juli 2017
Sidst verificeret
1. juli 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Neoplasmer efter histologisk type
- Neoplasmer
- Neoplasmer, kirtel og epitel
- Karcinom
- 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
- Carboplatin
- Bevacizumab
Andre undersøgelses-id-numre
- AVF4095g
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 .