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Fallopian Tube CancerPhase 3OVATURENCT00382811

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

A Phase 3 study testing phenoxodiol and carboplatin in people with Fallopian Tube Cancer and Peritoneal Neoplasms, run by MEI Pharma, Inc. at 70 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
phenoxodiol and carboplatin
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
70 sitesin 7 countries
Study dates
Oct 2006to Apr 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 19Show fewer
  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • 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.

Trial locations and contacts

70 sites in 7 countries.

70 sites in 7 countries

United States37 sites

  • The University of New Mexico Cancer Research and Treatment Center

    Albuquerque, New Mexico, 87131-0001

  • Northern Virginia Pelvic Surgery Associates

    Annadale, Virginia, 22003

  • Piedmont Hospital

    Atlanta, Georgia, 30309

  • Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Greater Baltimore Medical Centre

    Baltimore, Maryland, 21204

  • Schwartz Gynecologic Oncology

    Brightwaters, New York, 11718

  • Hope Cancer Clinic

    Brownsville, Texas, 78526

  • Gabrail Cancer Center

    Canton, Ohio, 44718

  • Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Chattanooga GYN Oncology

    Chattanooga, Tennessee, 37403

  • Chattanooga's Program In Women's Oncology

    Chattanooga, Tennessee, 37403

  • The Center for Cancer & Hematological Disease

    Cherry Hill, New Jersey, 08003

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • OSU James Cancer Hospital & Solove Research Institute

    Columbus, Ohio, 43210

  • University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center

    Dallas, Texas, 75390

  • Miami Valley Hospital

    Dayton, Ohio

  • Glendale Adventist

    Glendale, California, 91206

  • Gynecologic Oncology of West Michigan

    Grand Rapids, Michigan, 49546

  • Brody School of Medical at East Carolina University

    Greenville, North Carolina, 27834

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Hall and Martin MDS, P.C.

    Knoxville, Tennessee, 37920

  • Kaiser Permanente Los Angeles Medical Center

    Los Angeles, California, 90027

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Hematology and Oncology Specialists, LLC

    Metairie, Louisiana, 70006

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07754

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • New York Downtown Hospital

    New York, New York, 10038

  • Gynecology Oncology Associates

    Newport Beach, California, 92663

  • Gynecologic Oncology Associates

    Pembroke Pines, Florida, 33028

  • University of Rochester Gynecologic Oncology Associates

    Rochester, New York, 14620

  • Virginia Mason Medical Center Department of Hematology/Oncology

    Seattle, Washington, 98101

  • Providence Hospital and Medical Centers

    Southfield, Michigan, 48075

  • Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center)

    Stamford, Connecticut, 06902

  • Arizona Clinical Research Center, Inc.

    Tuscon, Arizona, 85715

  • Associates in Women's Health

    Wichita, Kansas, 67214

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

Other trials in United States

United Kingdom11 sites

  • Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building

    Birmingham, B18 7QH

  • Ninewells Hospital

    Dundee, DD1 9SY

  • Edinburgh Cancer Research Centre Western General Hospital

    Edinburgh, EH4 2XR

  • The Beatson West of Scotland Cancer Centre

    Glasgow, G12 0YH

  • St James University Hospital

    Leeds, LS9 7TF

  • Hammersmith Hospital

    London, W12 0HS

  • Cancer Research UK & UCL Cancer Trials Center

    London, W1T 4TJ

  • Clatterbridge Centre for Oncology

    Metropolitan Borough of Wirral, CH63 4JY

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

  • Royal Marsden NHS Foundation Trust

    Sutton, SM2 5PT

  • Yeovil District Hospital

    Yeovil, Somerset, BA21 4AT

Other trials in United Kingdom

Poland7 sites

  • Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie Oddzial Onkologii Ginekologicznej

    Bialystok, 15-027

  • Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku

    Gdansk, 80-402

  • Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach

    Gliwice, 44-101

  • Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Oddzial w Krakowie Klinika Ginekologii Onkologicznej

    Krakow, 31-115

  • Centrum Onkologii Ziemi

    Lublin, 20-090

  • Ginekologiczno - Polozniczy Szpital Kliniczny AM im. K. Marcinkowskiego w Poznaniu SPZOZ Klinika Onkologii Ginekologicznej

    Poznan, 60-535

  • Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Klinika Nowotworow Narzadow Plciowych Kobiecych

    Warsaw, 02-781

Other trials in Poland

Spain6 sites

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, Barcelona, 08003

  • Hospital General Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia

  • Mater Adult Hospital

    Brisbane, Queensland

  • Prince of Wales Hospital

    Randwick, New South Wales

  • Royal North Shore Hospital

    Sydney, New South Wales, 2065

  • Westmead Hospital

    Westmead, New South Wales

Other trials in Australia

Belgium2 sites

  • UZ Antwerpen

    Edegem, 2650

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Italy2 sites

  • IEO- Istituto Europeo di Oncologia

    Milan, 20141

  • Istitutio Fisioterapici Ospitaleri

    Roma, 00144

Other trials in Italy

About this study

Official title: 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.

Being tested
phenoxodiol, carboplatin, placebo
Keywords
Recurrent Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer, Peritoneal Cavity Cancer, Stage III Ovarian Epithelial Cancer
Medical subject headings
Fallopian Tube Neoplasms, Peritoneal Neoplasms, Ovarian Neoplasms, Carcinoma, Ovarian Epithelial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • phenoxodiolDrug

    400mg phenoxodiol three times daily in 28 day cycles.

  • carboplatinDrug

    AUC=2 weekly in 28 day cycles

  • placeboDrug

    every 8 hours daily in 28 day cycles

Study groups in NCT00382811
Study groupRoleWhat they receive
1ExperimentalDaily Phenoxodiol + weekly carboplatin
Receives: Drug: phenoxodiol; Drug: carboplatin
2Active comparatorDaily phenoxodiol placebo + weekly carboplatin
Receives: Drug: carboplatin; Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death

    Measured: Progression Free Survival

Secondary outcomes (1)

  1. The secondary efficacy end-point is overall survival (OS)

    Measured: Overall survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2006 (estimated)
  2. Study startOct 2006
  3. Primary completionApr 2009
  4. Study completionApr 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00382811
Sponsor's protocol ID
NV06-0039
Acronym
OVATURE
Status last verified
Jul 2016
First submitted
28 Sep 2006
Last updated
18 Jul 2016
Results posted
No

Publications

  • 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.

    PubMed 24318743

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing phenoxodiol and carboplatin in people with Fallopian Tube Cancer and Peritoneal Neoplasms, run by MEI Pharma, Inc. at 70 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 70 sites in United States, United Kingdom, Poland, Spain, Australia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00382811, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2016.

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