NCT00434642

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P50-P75 for phase_3 ovarian-cancer

Timeline
Completed

Started Apr 2007

Typical duration for phase_3 ovarian-cancer

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 13, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

November 3, 2011

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
Last Updated

August 9, 2017

Status Verified

July 1, 2017

Enrollment Period

3.4 years

First QC Date

February 9, 2007

Results QC Date

September 26, 2011

Last Update Submit

July 10, 2017

Conditions

Ovarian Cancer

Keywords

AvastinOvarian carcinomaPeritoneal carcinomaPeritoneal cancerFallopian tube cancerFallopian tube carcinomaOCEANS

Outcome Measures

Primary Outcomes (1)

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

    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)

Secondary Outcomes (5)

  • Percentage of Patients With an Objective Response as Determined by the Investigator, Per Response Evaluation Criteria for Solid Tumors (RECIST)

    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)

    From randomization through September 17, 2010 (up to 3 years, 5 months)

  • Overall Survival

    From randomization through July 19, 2013 (up to 6 years, 3 months)

  • Percentage of Patients Who Had a Gastrointestinal Perforation (GIP)

    From randomization through September 17, 2010 (up to 3 years, 5 months)

  • Percentage of Patients Who Had at Least 1 Adverse Event

    From randomization through July 19, 2013 (up to 6 years, 3 months)

Study Arms (2)

Carboplatin and gemcitabine + bevacizumab

EXPERIMENTAL

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.

Drug: CarboplatinDrug: GemcitabineDrug: Bevacizumab

Carboplatin and gemcitabine + placebo

ACTIVE COMPARATOR

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.

Drug: CarboplatinDrug: GemcitabineDrug: Placebo

Interventions

CarboplatinDRUG

Carboplatin was provided as commercially available drug.

Carboplatin and gemcitabine + bevacizumabCarboplatin and gemcitabine + placebo
GemcitabineDRUG

Gemcitabine was provided as commercially available drug.

Carboplatin and gemcitabine + bevacizumabCarboplatin and gemcitabine + placebo
BevacizumabDRUG

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.

Also known as: Avastin
Carboplatin and gemcitabine + bevacizumab
PlaceboDRUG

Placebo consisted of the vehicle for bevacizumab without the antibody and contained sodium phosphate, trehalose, polysorbate 20, and Sterile Water for Injection, USP.

Carboplatin and gemcitabine + placebo

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PMID: 37185961DERIVED

  • 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.

    PMID: 26271155DERIVED

  • 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.

    PMID: 21941283DERIVED

MeSH Terms

Conditions

Ovarian NeoplasmsFallopian Tube Neoplasms

Interventions

CarboplatinGemcitabineBevacizumab

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersFallopian Tube Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsHeterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Results Point of Contact

Title
Medical Communications
Organization
Hoffman-LaRoche
800-821-8590

Study Officials

  • Amreen Husain, MD

    Genentech, Inc.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2007

First Posted

February 13, 2007

Study Start

April 1, 2007

Primary Completion

September 1, 2010

Study Completion

July 1, 2013

Last Updated

August 9, 2017

Results First Posted

November 3, 2011

Record last verified: 2017-07