OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer (OVATURE)

July 13, 2016 updated by: MEI Pharma, Inc.

Multi-Center, Randomized, Double-Blind, Phase III Efficacy Study Comparing Phenoxodiol in Combination With Carboplatin Versus Carboplatin With Placebo in Patients With Platinum-Resistant or Platinum-Refractory Late-Stage Epithelial Ovarian, Fallopian or Primary Peritoneal Cancer Following at Least Second Line Platinum Therapy

The purpose of this project is to see if weekly carboplatin compared with phenoxodiol in combination with weekly carboplatin, is effective against late stage ovarian cancer and to see what, if any, side-effects of treatment may result.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia
        • Prince of Wales Hospital
      • Sydney, New South Wales, Australia, 2065
        • Royal North Shore Hospital
      • Westmead, New South Wales, Australia
        • Westmead Hospital
    • Queensland
      • Brisbane, Queensland, Australia
        • Mater Adult Hospital
    • South Australia
      • Adelaide, South Australia, Australia
        • Royal Adelaide Hospital
  • Belgium
      • Edegem, Belgium, 2650
        • UZ Antwerpen
      • Leuven, Belgium, 3000
        • UZ Leuven
  • Italy
      • Milano, Italy, 20141
        • IEO- Istituto Europeo di Oncologia
      • Roma, Italy, 00144
        • Istitutio Fisioterapici Ospitaleri
  • Poland
      • Bialystok, Poland, 15-027
        • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie Oddzial Onkologii Ginekologicznej
      • Gdansk, Poland, 80-402
        • Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku
      • Gliwice, Poland, 44-101
        • Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach
      • Krakow, Poland, 31-115
        • Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Oddzial w Krakowie Klinika Ginekologii Onkologicznej
      • Lublin, Poland, 20-090
        • Centrum Onkologii Ziemi
      • Poznan, Poland, 60-535
        • Ginekologiczno - Polozniczy Szpital Kliniczny AM im. K. Marcinkowskiego w Poznaniu SPZOZ Klinika Onkologii Ginekologicznej
      • Warszawa, Poland, 02-781
        • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Klinika Nowotworow Narzadow Plciowych Kobiecych
  • Spain
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08003
        • Hospital Del Mar
      • Barcelona, Spain, 08036
        • Hospital Clinic i Provincial de Barcelona
      • Barcelona, Spain, 08035
        • Hospital General Vall D'Hebron
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
  • United Kingdom
      • Birmingham, United Kingdom, B18 7QH
        • Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building
      • Dundee, United Kingdom, DD1 9SY
        • Ninewells Hospital
      • Edinburgh, United Kingdom, EH4 2XR
        • Edinburgh Cancer Research Centre Western General Hospital
      • Glasgow, United Kingdom, G12 0YH
        • The Beatson West of Scotland Cancer Centre
      • Leeds, United Kingdom, LS9 7TF
        • St James University Hospital
      • London, United Kingdom, W12 0HS
        • Hammersmith Hospital
      • London, United Kingdom, W1T 4TJ
        • Cancer Research UK & UCL Cancer Trials Center
      • Nottingham, United Kingdom, NG5 1PB
        • Nottingham University Hospitals NHS Trust
      • Sutton, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust
      • Wirral, United Kingdom, CH63 4JY
        • Clatterbridge Centre for Oncology
    • Somerset
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Yeovil District Hospital
  • United States
    • Arizona
      • Tuscon, Arizona, United States, 85715
        • Arizona Clinical Research Center, Inc.
    • California
      • Glendale, California, United States, 91206
        • Glendale Adventist
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Newport Beach, California, United States, 92663
        • Gynecology Oncology Associates
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Yale University School Of Medicine
      • Stamford, Connecticut, United States, 06902
        • Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center)
    • Florida
      • Pembroke Pines, Florida, United States, 33028
        • Gynecologic Oncology Associates
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Piedmont Hospital
      • Augusta, Georgia, United States, 30912
        • Medical College of Georgia Cancer Center
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Associates in Women's Health
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Hematology And Oncology Specialists, Llc
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Greater Baltimore Medical Centre
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Gynecologic Oncology of West Michigan
      • Southfield, Michigan, United States, 48075
        • Providence Hospital and Medical Centers
    • New Jersey
      • Cherry Hill, New Jersey, United States, 08003
        • The Center for Cancer & Hematological Disease
      • Neptune, New Jersey, United States, 07754
        • Jersey Shore Medical Center
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131-0001
        • The University of New Mexico Cancer Research and Treatment Center
    • New York
      • Brightwaters, New York, United States, 11718
        • Schwartz Gynecologic Oncology
      • New York, New York, United States, 10038
        • New York Downtown Hospital
      • Rochester, New York, United States, 14620
        • University of Rochester Gynecologic Oncology Associates
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Carolinas Medical Center
      • Greenville, North Carolina, United States, 27834
        • Brody School of Medical at East Carolina University
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gabrail Cancer Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43210
        • OSU James Cancer Hospital & Solove Research Institute
      • Dayton, Ohio, United States
        • Miami Valley Hospital
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga GYN Oncology
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga's Program in Women's Oncology
      • Knoxville, Tennessee, United States, 37920
        • Hall and Martin MDS, P.C.
      • Nashville, Tennessee, United States, 37203
        • Sarah Cannon Research Institute
    • Texas
      • Brownsville, Texas, United States, 78526
        • Hope Cancer Clinic
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
    • Virginia
      • Annadale, Virginia, United States, 22003
        • Northern Virginia Pelvic Surgery Associates
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center Department of Hematology/Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically-confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin
  • Recurrent or persistent advanced disease
  • Have measurable disease
  • Undergone at least two courses of therapy with a platinum drug (cisplatin or carboplatin) and have responded to the first of those courses of therapy as determined by either Response Evaluation Criteria in Solid Tumors (RECIST) or Gynecologic Cancer Intergroup (GCIG) criteria
  • Disease relapse as determined by either RECIST or GCIG criteria within 6 months of completion of the second or greater course of platinum therapy using a 2-, 3- or 4-weekly regimen and platinum-free interval of no greater than 6 months at the time of enrollment, being the time taken from the last day of platinum therapy
  • Any number of previous courses of platinum therapy or non-platinum therapy
  • Likely to survive at least 3 months
  • Karnofsky performance score of at least 60%

  • Have adequate physiological function without evidence of major organ dysfunction as evidenced by:

    • serum creatinine < 1.5 mg/dl
    • serum transaminase levels ≤ 3 x the upper limit of normal (ULN) for the reference laboratory and
    • bilirubin level < ULN

  • Have adequate hematological function defined by:

    • platelets > 100,000/mm3
    • white cell counts (WCC) > 3,000/mm3
    • neutrophils > 1,500/mm3
    • hemoglobin > 8.0 g/dl
  • Aged > 18
  • Be able to understand the risks and benefits of the study and give written informed consent to participation.

Exclusion Criteria:

  • Patients with mucinous histological type of ovarian cancer
  • Patients who have failed to show a clinical response (RECIST or GCIG criteria) to at least one prior course of platinum therapy
  • Patients with active infection
  • Patients with concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.)
  • Patients with a history of chronic active hepatitis or cirrhosis
  • Patients with HIV
  • Patients with active central nervous system (CNS) metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks.
  • Patients who have not recovered from the acute effects of any prior anti-neoplastic therapy
  • Patients with known hypersensitivity to platinum drugs that cannot be managed with concomitant medication.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Daily Phenoxodiol + weekly carboplatin
Drug: phenoxodiol
400mg phenoxodiol three times daily in 28 day cycles.
Drug: carboplatin
AUC=2 weekly in 28 day cycles
Active Comparator: 2
Daily phenoxodiol placebo + weekly carboplatin
Drug: carboplatin
AUC=2 weekly in 28 day cycles
Drug: placebo
every 8 hours daily in 28 day cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death
Time Frame: Progression Free Survival
Progression Free Survival

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary efficacy end-point is overall survival (OS)
Time Frame: Overall survival
Overall survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MEI Pharma, Inc.

Investigators

  • Study Director: Daniel P Gold, PhD, MEI Pharma, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Primary Completion (Actual)

April 1, 2009

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

September 28, 2006

First Submitted That Met QC Criteria

September 28, 2006

First Posted (Estimate)

October 2, 2006

Study Record Updates

Last Update Posted (Estimate)

July 18, 2016

Last Update Submitted That Met QC Criteria

July 13, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NV06-0039

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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