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

Ovarian Cancer Clinical Trial

— OVATURE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00382811
• Other study ID #: NV06-0039
• Status: Completed
• Phase: Phase 3
• First received: September 28, 2006
• Last updated: July 13, 2016
• Start date: October 2006
• Est. completion date: April 2011

Study information

• Verified date: July 2016
• Source: MEI Pharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustralia: Department of Health and Ageing Therapeutic Goods Administration
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 142
• Est. completion date: April 2011
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Mater Adult Hospital	Brisbane	Queensland
Australia	Prince of Wales Hospital	Randwick	New South Wales
Australia	Royal North Shore Hospital	Sydney	New South Wales
Australia	Westmead Hospital	Westmead	New South Wales
Belgium	UZ Antwerpen	Edegem
Belgium	UZ Leuven	Leuven
Italy	IEO- Istituto Europeo di Oncologia	Milano
Italy	Istitutio Fisioterapici Ospitaleri	Roma
Poland	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	Warszawa
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Germans Trias i Pujol	Badalona	Barcelona
Spain	Hospital Clinic i Provincial de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital General Vall d'Hebron	Barcelona
Spain	Hospital General Universitario de Valencia	Valencia
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	Cancer Research UK & UCL Cancer Trials Center	London
United Kingdom	Hammersmith Hospital	London
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Royal Marsden NHS Foundation Trust	Sutton
United Kingdom	Clatterbridge Centre for Oncology	Wirral
United Kingdom	Yeovil District Hospital	Yeovil	Somerset
United States	The University of New Mexico Cancer Research and Treatment Center	Albuquerque	New Mexico
United States	Northern Virginia Pelvic Surgery Associates	Annadale	Virginia
United States	Piedmont Hospital	Atlanta	Georgia
United States	Medical College of Georgia Cancer Center	Augusta	Georgia
United States	Greater Baltimore Medical Centre	Baltimore	Maryland
United States	Schwartz Gynecologic Oncology	Brightwaters	New York
United States	Hope Cancer Clinic	Brownsville	Texas
United States	Gabrail Cancer Center	Canton	Ohio
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Chattanooga GYN Oncology	Chattanooga	Tennessee
United States	Chattanooga's Program In Women's Oncology	Chattanooga	Tennessee
United States	The Center for Cancer & Hematological Disease	Cherry Hill	New Jersey
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	OSU James Cancer Hospital & Solove Research Institute	Columbus	Ohio
United States	University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center	Dallas	Texas
United States	Miami Valley Hospital	Dayton	Ohio
United States	Glendale Adventist	Glendale	California
United States	Gynecologic Oncology of West Michigan	Grand Rapids	Michigan
United States	Brody School of Medical at East Carolina University	Greenville	North Carolina
United States	Baylor College of Medicine	Houston	Texas
United States	Hall and Martin MDS, P.C.	Knoxville	Tennessee
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Kaiser Permanente Los Angeles Medical Center	Los Angeles	California
United States	Hematology and Oncology Specialists, LLC	Metairie	Louisiana
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Jersey Shore Medical Center	Neptune	New Jersey
United States	Yale University School of Medicine	New Haven	Connecticut
United States	New York Downtown Hospital	New York	New York
United States	Gynecology Oncology Associates	Newport Beach	California
United States	Gynecologic Oncology Associates	Pembroke Pines	Florida
United States	University of Rochester Gynecologic Oncology Associates	Rochester	New York
United States	Virginia Mason Medical Center Department of Hematology/Oncology	Seattle	Washington
United States	Providence Hospital and Medical Centers	Southfield	Michigan
United States	Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center)	Stamford	Connecticut
United States	Arizona Clinical Research Center, Inc.	Tuscon	Arizona
United States	Associates in Women's Health	Wichita	Kansas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MEI Pharma, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Italy,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death		Progression Free Survival	No
Secondary	The secondary efficacy end-point is overall survival (OS)		Overall survival	No

External Links

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