OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
NCT ID: NCT00382811
Last Updated: 2016-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
142 participants
INTERVENTIONAL
2006-10-31
2011-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Newly Diagnosed Stage III/IV Ovarian Cancer, Neoadjuvant Carbo/taxol/pembro, Maintenance Olaparib/pembro
NCT05952453
A Study of Carboplatin and DOXIL Plus Bevacizumab in Patients With Platinum Sensitive Recurrent Ovarian, Fallopian Tube and Primary Peritoneal Cancers
NCT00698451
Phase II CT-2103/Carboplatin in Ovarian Cancer
NCT00069901
Carboplatin and Paclitaxel With or Without Bevacizumab in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Primary Peritoneal, or Fallopian Tube Cancer
NCT00262847
Bevacizumab and Carboplatin for Patients With Ovarian Cancer
NCT00744718
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
Daily Phenoxodiol + weekly carboplatin
phenoxodiol
400mg phenoxodiol three times daily in 28 day cycles.
carboplatin
AUC=2 weekly in 28 day cycles
2
Daily phenoxodiol placebo + weekly carboplatin
carboplatin
AUC=2 weekly in 28 day cycles
placebo
every 8 hours daily in 28 day cycles
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
phenoxodiol
400mg phenoxodiol three times daily in 28 day cycles.
carboplatin
AUC=2 weekly in 28 day cycles
placebo
every 8 hours daily in 28 day cycles
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MEI Pharma, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Daniel P Gold, PhD
Role: STUDY_DIRECTOR
MEI Pharma, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Arizona Clinical Research Center, Inc.
Tuscon, Arizona, United States
Glendale Adventist
Glendale, California, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Gynecology Oncology Associates
Newport Beach, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center)
Stamford, Connecticut, United States
Gynecologic Oncology Associates
Pembroke Pines, Florida, United States
Piedmont Hospital
Atlanta, Georgia, United States
Medical College of Georgia Cancer Center
Augusta, Georgia, United States
Associates in Women's Health
Wichita, Kansas, United States
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, United States
Greater Baltimore Medical Centre
Baltimore, Maryland, United States
Gynecologic Oncology of West Michigan
Grand Rapids, Michigan, United States
Providence Hospital and Medical Centers
Southfield, Michigan, United States
The Center for Cancer & Hematological Disease
Cherry Hill, New Jersey, United States
Jersey Shore Medical Center
Neptune City, New Jersey, United States
The University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States
Schwartz Gynecologic Oncology
Brightwaters, New York, United States
New York Downtown Hospital
New York, New York, United States
University of Rochester Gynecologic Oncology Associates
Rochester, New York, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
Brody School of Medical at East Carolina University
Greenville, North Carolina, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
Gabrail Cancer Center
Canton, Ohio, United States
MetroHealth Medical Center
Cleveland, Ohio, United States
OSU James Cancer Hospital & Solove Research Institute
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
Chattanooga GYN Oncology
Chattanooga, Tennessee, United States
Chattanooga's Program In Women's Oncology
Chattanooga, Tennessee, United States
Hall and Martin MDS, P.C.
Knoxville, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Hope Cancer Clinic
Brownsville, Texas, United States
University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Northern Virginia Pelvic Surgery Associates
Annadale, Virginia, United States
Virginia Mason Medical Center Department of Hematology/Oncology
Seattle, Washington, United States
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia
Mater Adult Hospital
Brisbane, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
UZ Antwerpen
Edegem, , Belgium
UZ Leuven
Leuven, , Belgium
IEO- Istituto Europeo di Oncologia
Milan, , Italy
Istitutio Fisioterapici Ospitaleri
Roma, , Italy
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie Oddzial Onkologii Ginekologicznej
Bialystok, , Poland
Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku
Gdansk, , Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach
Gliwice, , Poland
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Oddzial w Krakowie Klinika Ginekologii Onkologicznej
Krakow, , Poland
Centrum Onkologii Ziemi
Lublin, , Poland
Ginekologiczno - Polozniczy Szpital Kliniczny AM im. K. Marcinkowskiego w Poznaniu SPZOZ Klinika Onkologii Ginekologicznej
Poznan, , Poland
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Klinika Nowotworow Narzadow Plciowych Kobiecych
Warsaw, , Poland
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital del Mar
Barcelona, Barcelona, Spain
Hospital General Universitario de Alicante
Alicante, , Spain
Hospital General Vall d'Hebron
Barcelona, , Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Yeovil District Hospital
Yeovil, Somerset, United Kingdom
Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building
Birmingham, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Edinburgh Cancer Research Centre Western General Hospital
Edinburgh, , United Kingdom
The Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
St James University Hospital
Leeds, , United Kingdom
Hammersmith Hospital
London, , United Kingdom
Cancer Research UK & UCL Cancer Trials Center
London, , United Kingdom
Clatterbridge Centre for Oncology
Metropolitan Borough of Wirral, , United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, , United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Fotopoulou C, Vergote I, Mainwaring P, Bidzinski M, Vermorken JB, Ghamande SA, Harnett P, Del Prete SA, Green JA, Spaczynski M, Blagden S, Gore M, Ledermann J, Kaye S, Gabra H. Weekly AUC2 carboplatin in acquired platinum-resistant ovarian cancer with or without oral phenoxodiol, a sensitizer of platinum cytotoxicity: the phase III OVATURE multicenter randomized study. Ann Oncol. 2014 Jan;25(1):160-5. doi: 10.1093/annonc/mdt515. Epub 2013 Dec 5.
Related Links
Access external resources that provide additional context or updates about the study.
Click here for more information on the study and sponsor.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NV06-0039
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.