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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 uppdaterad 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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

484

Fas

  • Fas 3

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Behandling
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Dubbel

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: 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.
Läkemedel: Carboplatin
Carboplatin was provided as commercially available drug.
Läkemedel: Gemcitabine
Gemcitabine was provided as commercially available drug.
Läkemedel: 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.
Andra namn:
  • 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.
Läkemedel: Carboplatin
Carboplatin was provided as commercially available drug.
Läkemedel: Gemcitabine
Gemcitabine was provided as commercially available drug.
Läkemedel: Placebo
Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Progression Free Survival (PFS) as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)
Tidsram: 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)
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: From randomization through July 19, 2013 (up to 6 years, 3 months)
From randomization through July 19, 2013 (up to 6 years, 3 months)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Genentech, Inc.

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart

1 april 2007

Primärt slutförande (Faktisk)

1 september 2010

Avslutad studie (Faktisk)

1 juli 2013

Studieregistreringsdatum

Först inskickad

9 februari 2007

Först inskickad som uppfyllde QC-kriterierna

9 februari 2007

Första postat (Uppskatta)

13 februari 2007

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 augusti 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

10 juli 2017

Senast verifierad

1 juli 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • AVF4095g

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