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

Phase 3

Completed

Conditions: Fallopian Tube Cancer
Peritoneal Neoplasms
Ovarian Cancer

Interventions: Drug: carboplatin
Drug: phenoxodiol
Drug: placebo

Registration Number: NCT00382811

Lead Sponsor: MEI Pharma, Inc.

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 142

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	carboplatin	Daily phenoxodiol placebo + weekly carboplatin
2	placebo	Daily phenoxodiol placebo + weekly carboplatin
1	carboplatin	Daily Phenoxodiol + weekly carboplatin
1	phenoxodiol	Daily Phenoxodiol + weekly carboplatin

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
The secondary efficacy end-point is overall survival (OS)	Overall survival

Trial Locations

Locations (70): Baylor College of Medicine
🇺🇸
Houston, Texas, United States
Associates in Women's Health
🇺🇸
Wichita, Kansas, United States
Sarah Cannon Research Institute
🇺🇸
Nashville, Tennessee, United States
The Center for Cancer & Hematological Disease
🇺🇸
Cherry Hill, New Jersey, United States
Hall and Martin MDS, P.C.
🇺🇸
Knoxville, Tennessee, United States
Hematology and Oncology Specialists, LLC
🇺🇸
Metairie, Louisiana, United States
Cedars-Sinai Medical Center
🇺🇸
Los Angeles, California, United States
Arizona Clinical Research Center, Inc.
🇺🇸
Tuscon, Arizona, United States
OSU James Cancer Hospital & Solove Research Institute
🇺🇸
Columbus, Ohio, United States
Miami Valley Hospital
🇺🇸
Dayton, Ohio, United States
Gynecologic Oncology Associates
🇺🇸
Pembroke Pines, Florida, United States
Gabrail Cancer Center
🇺🇸
Canton, Ohio, United States
Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku
🇵🇱
Gdansk, Poland
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Oddzial w Krakowie Klinika Ginekologii Onkologicznej
🇵🇱
Krakow, Poland
IEO- Istituto Europeo di Oncologia
🇮🇹
Milano, Italy
Chattanooga's Program In Women's Oncology
🇺🇸
Chattanooga, Tennessee, United States
Hospital General Universitario de Alicante
🇪🇸
Alicante, Spain
Gynecologic Oncology of West Michigan
🇺🇸
Grand Rapids, Michigan, United States
Chattanooga GYN Oncology
🇺🇸
Chattanooga, Tennessee, United States
Wake Forest University Health Sciences
🇺🇸
Winston-Salem, North Carolina, United States
UZ Antwerpen
🇧🇪
Edegem, Belgium
UZ Leuven
🇧🇪
Leuven, Belgium
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach
🇵🇱
Gliwice, Poland
Centrum Onkologii Ziemi
🇵🇱
Lublin, Poland
Hospital del Mar
🇪🇸
Barcelona, Spain
Royal Adelaide Hospital
🇦🇺
Adelaide, South Australia, Australia
St James University Hospital
🇬🇧
Leeds, United Kingdom
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie Oddzial Onkologii Ginekologicznej
🇵🇱
Bialystok, Poland
Ginekologiczno - Polozniczy Szpital Kliniczny AM im. K. Marcinkowskiego w Poznaniu SPZOZ Klinika Onkologii Ginekologicznej
🇵🇱
Poznan, Poland
Istitutio Fisioterapici Ospitaleri
🇮🇹
Roma, Italy
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Klinika Nowotworow Narzadow Plciowych Kobiecych
🇵🇱
Warszawa, Poland
Hospital General Vall d'Hebron
🇪🇸
Barcelona, Spain
Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building
🇬🇧
Birmingham, United Kingdom
Royal Marsden NHS Foundation Trust
🇬🇧
Sutton, United Kingdom
Hospital Germans Trias i Pujol
🇪🇸
Badalona, Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
🇪🇸
Barcelona, Spain
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
Cancer Research UK & UCL Cancer Trials Center
🇬🇧
London, United Kingdom
Hammersmith Hospital
🇬🇧
London, United Kingdom
Clatterbridge Centre for Oncology
🇬🇧
Wirral, United Kingdom
Carolinas Medical Center
🇺🇸
Charlotte, North Carolina, United States
MetroHealth Medical Center
🇺🇸
Cleveland, Ohio, United States
Virginia Mason Medical Center Department of Hematology/Oncology
🇺🇸
Seattle, Washington, United States
Hospital General Universitario de Valencia
🇪🇸
Valencia, Spain
Brody School of Medical at East Carolina University
🇺🇸
Greenville, North Carolina, United States
Kaiser Permanente Los Angeles Medical Center
🇺🇸
Los Angeles, California, United States
Yale University School of Medicine
🇺🇸
New Haven, Connecticut, United States
Piedmont Hospital
🇺🇸
Atlanta, Georgia, United States
Gynecology Oncology Associates
🇺🇸
Newport Beach, California, United States
Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center)
🇺🇸
Stamford, Connecticut, United States
Medical College of Georgia Cancer Center
🇺🇸
Augusta, Georgia, United States
Greater Baltimore Medical Centre
🇺🇸
Baltimore, Maryland, United States
Providence Hospital and Medical Centers
🇺🇸
Southfield, Michigan, United States
Jersey Shore Medical Center
🇺🇸
Neptune, New Jersey, United States
The University of New Mexico Cancer Research and Treatment Center
🇺🇸
Albuquerque, New Mexico, United States
New York Downtown Hospital
🇺🇸
New York, New York, United States
Schwartz Gynecologic Oncology
🇺🇸
Brightwaters, New York, United States
University of Rochester Gynecologic Oncology Associates
🇺🇸
Rochester, New York, United States
University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
🇺🇸
Dallas, Texas, United States
Northern Virginia Pelvic Surgery Associates
🇺🇸
Annadale, Virginia, United States
Prince of Wales Hospital
🇦🇺
Randwick, New South Wales, Australia
Hope Cancer Clinic
🇺🇸
Brownsville, Texas, United States
Westmead Hospital
🇦🇺
Westmead, New South Wales, Australia
Royal North Shore Hospital
🇦🇺
Sydney, New South Wales, Australia
Yeovil District Hospital
🇬🇧
Yeovil, Somerset, United Kingdom
Nottingham University Hospitals NHS Trust
🇬🇧
Nottingham, United Kingdom
Glendale Adventist
🇺🇸
Glendale, California, United States
Mater Adult Hospital
🇦🇺
Brisbane, Queensland, Australia