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A Study of Carboplatin and Gemcitabine Plus Bevacizumab in Patients With Ovary, Peritoneal, or Fallopian Tube Carcinoma (OCEANS)

10. juli 2017 oppdatert av: 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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

484

Fase

  • Fase 3

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Hunn

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Carboplatin
Carboplatin was provided as commercially available drug.
Legemiddel: Gemcitabine
Gemcitabine was provided as commercially available drug.
Legemiddel: Bevacizumab
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 navn:
  • Avastin
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.
Legemiddel: Carboplatin
Carboplatin was provided as commercially available drug.
Legemiddel: Gemcitabine
Gemcitabine was provided as commercially available drug.
Legemiddel: Placebo
Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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)
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.
From randomization through September 17, 2010 (up to 3 years, 5 months)

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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)
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.
From randomization through September 17, 2010 (up to 3 years, 5 months)
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)
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.
From randomization through September 17, 2010 (up to 3 years, 5 months)
Overall Survival
Tidsramme: From randomization through July 19, 2013 (up to 6 years, 3 months)
Overall survival was defined as the time from randomization to death from any cause.
From randomization through July 19, 2013 (up to 6 years, 3 months)
Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)
Tidsramme: From randomization through September 17, 2010 (up to 3 years, 5 months)
A gastrointestinal perforation is a hole that develops through the entire wall of the stomach, small intestine, large bowel, or gallbladder.
From randomization through September 17, 2010 (up to 3 years, 5 months)
Percentage of Patients Who Had at Least 1 Adverse Event
Tidsramme: From randomization through July 19, 2013 (up to 6 years, 3 months)
From randomization through July 19, 2013 (up to 6 years, 3 months)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Genentech, Inc.

Etterforskere

  • Studieleder: Amreen Husain, MD, Genentech, Inc.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. april 2007

Primær fullføring (Faktiske)

1. september 2010

Studiet fullført (Faktiske)

1. juli 2013

Datoer for studieregistrering

Først innsendt

9. februar 2007

Først innsendt som oppfylte QC-kriteriene

9. februar 2007

Først lagt ut (Anslag)

13. februar 2007

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. august 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. juli 2017

Sist bekreftet

1. juli 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • AVF4095g

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