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

NCT00382811 | Completed Phase 3

• 1 other identifier: NV06-0039
• Study Type: interventional
• Target: 142
• Locations: 7 countries
• Sites: 70

Brief 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.

Conditions

Fallopian Tube Cancer; Peritoneal Neoplasms; Ovarian Cancer

Keywords

Recurrent Ovarian Epithelial Cancer; Stage IV Ovarian Epithelial Cancer; Peritoneal Cavity Cancer; Stage III Ovarian Epithelial Cancer

Outcome Measures

Primary Outcomes (1)

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

  Progression Free Survival

Secondary Outcomes (1)

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

  Overall survival

Study Arms (2)

1

EXPERIMENTAL

Daily Phenoxodiol + weekly carboplatin

Drug: phenoxodiol; Drug: carboplatin

2

ACTIVE COMPARATOR

Daily phenoxodiol placebo + weekly carboplatin

Drug: carboplatin; Drug: placebo

Interventions

phenoxodiol DRUG

400mg phenoxodiol three times daily in 28 day cycles.

1

carboplatin DRUG

AUC=2 weekly in 28 day cycles

1; 2

placebo DRUG

every 8 hours daily in 28 day cycles

2

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MEI Pharma, Inc.: lead

Study Sites (70)

Arizona Clinical Research Center, Inc.

Tuscon, Arizona, 85715, United States

Location

Glendale Adventist

Glendale, California, 91206, United States

Location

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, 90027, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Gynecology Oncology Associates

Newport Beach, California, 92663, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

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

Stamford, Connecticut, 06902, United States

Location

Gynecologic Oncology Associates

Pembroke Pines, Florida, 33028, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Medical College of Georgia Cancer Center

Augusta, Georgia, 30912, United States

Location

Associates in Women's Health

Wichita, Kansas, 67214, United States

Location

Hematology and Oncology Specialists, LLC

Metairie, Louisiana, 70006, United States

Location

Greater Baltimore Medical Centre

Baltimore, Maryland, 21204, United States

Location

Gynecologic Oncology of West Michigan

Grand Rapids, Michigan, 49546, United States

Location

Providence Hospital and Medical Centers

Southfield, Michigan, 48075, United States

Location

The Center for Cancer & Hematological Disease

Cherry Hill, New Jersey, 08003, United States

Location

Jersey Shore Medical Center

Neptune City, New Jersey, 07754, United States

Location

The University of New Mexico Cancer Research and Treatment Center

Albuquerque, New Mexico, 87131-0001, United States

Location

Schwartz Gynecologic Oncology

Brightwaters, New York, 11718, United States

Location

New York Downtown Hospital

New York, New York, 10038, United States

Location

University of Rochester Gynecologic Oncology Associates

Rochester, New York, 14620, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28204, United States

Location

Brody School of Medical at East Carolina University

Greenville, North Carolina, 27834, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

Location

Gabrail Cancer Center

Canton, Ohio, 44718, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

OSU James Cancer Hospital & Solove Research Institute

Columbus, Ohio, 43210, United States

Location

Miami Valley Hospital

Dayton, Ohio, United States

Location

Chattanooga GYN Oncology

Chattanooga, Tennessee, 37403, United States

Location

Chattanooga's Program In Women's Oncology

Chattanooga, Tennessee, 37403, United States

Location

Hall and Martin MDS, P.C.

Knoxville, Tennessee, 37920, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Hope Cancer Clinic

Brownsville, Texas, 78526, United States

Location

University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center

Dallas, Texas, 75390, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Northern Virginia Pelvic Surgery Associates

Annadale, Virginia, 22003, United States

Location

Virginia Mason Medical Center Department of Hematology/Oncology

Seattle, Washington, 98101, United States

Location

Prince of Wales Hospital

Randwick, New South Wales, Australia

Location

Royal North Shore Hospital

Sydney, New South Wales, 2065, Australia

Location

Westmead Hospital

Westmead, New South Wales, Australia

Location

Mater Adult Hospital

Brisbane, Queensland, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

IEO- Istituto Europeo di Oncologia

Milan, 20141, Italy

Location

Istitutio Fisioterapici Ospitaleri

Roma, 00144, Italy

Location

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

Bialystok, 15-027, Poland

Location

Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku

Gdansk, 80-402, Poland

Location

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

Gliwice, 44-101, Poland

Location

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

Krakow, 31-115, Poland

Location

Centrum Onkologii Ziemi

Lublin, 20-090, Poland

Location

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

Poznan, 60-535, Poland

Location

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

Warsaw, 02-781, Poland

Location

Hospital Germans Trias i Pujol

Badalona, Barcelona, 08916, Spain

Location

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital General Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic i Provincial de Barcelona

Barcelona, 08036, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Yeovil District Hospital

Yeovil, Somerset, BA21 4AT, United Kingdom

Location

Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building

Birmingham, B18 7QH, United Kingdom

Location

Ninewells Hospital

Dundee, DD1 9SY, United Kingdom

Location

Edinburgh Cancer Research Centre Western General Hospital

Edinburgh, EH4 2XR, United Kingdom

Location

The Beatson West of Scotland Cancer Centre

Glasgow, G12 0YH, United Kingdom

Location

St James University Hospital

Leeds, LS9 7TF, United Kingdom

Location

Hammersmith Hospital

London, W12 0HS, United Kingdom

Location

Cancer Research UK & UCL Cancer Trials Center

London, W1T 4TJ, United Kingdom

Location

Clatterbridge Centre for Oncology

Metropolitan Borough of Wirral, CH63 4JY, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

Location

Royal Marsden NHS Foundation Trust

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24318743 DERIVED

Related Links

• Click here for more information on the study and sponsor.

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Peritoneal Neoplasms; Ovarian Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

phenoxodiol; Carboplatin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Daniel P Gold, PhD

  MEI Pharma, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2006
• First Posted: October 2, 2006
• Study Start: October 1, 2006
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2011
• Last Updated: July 18, 2016

Record last verified: 2016-07

Locations

AU (5); IT (2); GB (11); US (37); PL (7); ES (6); BE (2)