Back to resultsOVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer (OVATURE)
Primary Purpose
Fallopian Tube Cancer, Peritoneal Neoplasms, Ovarian Cancer
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
phenoxodiol
carboplatin
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring Recurrent Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer, Peritoneal Cavity Cancer, Stage III Ovarian Epithelial Cancer
Eligibility Criteria
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.
Sites / Locations
- Arizona Clinical Research Center, Inc.
- Glendale Adventist
- Kaiser Permanente Los Angeles Medical Center
- Cedars-Sinai Medical Center
- Gynecology Oncology Associates
- Yale University School of Medicine
- Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center)
- Gynecologic Oncology Associates
- Piedmont Hospital
- Medical College of Georgia Cancer Center
- Associates in Women's Health
- Hematology and Oncology Specialists, LLC
- Greater Baltimore Medical Centre
- Gynecologic Oncology of West Michigan
- Providence Hospital and Medical Centers
- The Center for Cancer & Hematological Disease
- Jersey Shore Medical Center
- The University of New Mexico Cancer Research and Treatment Center
- Schwartz Gynecologic Oncology
- New York Downtown Hospital
- University of Rochester Gynecologic Oncology Associates
- Carolinas Medical Center
- Brody School of Medical at East Carolina University
- Wake Forest University Health Sciences
- Gabrail Cancer Center
- MetroHealth Medical Center
- OSU James Cancer Hospital & Solove Research Institute
- Miami Valley Hospital
- Chattanooga GYN Oncology
- Chattanooga's Program In Women's Oncology
- Hall and Martin MDS, P.C.
- Sarah Cannon Research Institute
- Hope Cancer Clinic
- University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
- Baylor College of Medicine
- Northern Virginia Pelvic Surgery Associates
- Virginia Mason Medical Center Department of Hematology/Oncology
- Prince of Wales Hospital
- Royal North Shore Hospital
- Westmead Hospital
- Mater Adult Hospital
- Royal Adelaide Hospital
- UZ Antwerpen
- UZ Leuven
- IEO- Istituto Europeo di Oncologia
- Istitutio Fisioterapici Ospitaleri
- Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie Oddzial Onkologii Ginekologicznej
- Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku
- Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach
- Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Oddzial w Krakowie Klinika Ginekologii Onkologicznej
- Centrum Onkologii Ziemi
- Ginekologiczno - Polozniczy Szpital Kliniczny AM im. K. Marcinkowskiego w Poznaniu SPZOZ Klinika Onkologii Ginekologicznej
- Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Klinika Nowotworow Narzadow Plciowych Kobiecych
- Hospital Germans Trias i Pujol
- Hospital General Universitario de Alicante
- Hospital del Mar
- Hospital General Vall d'Hebron
- Hospital Clinic i Provincial de Barcelona
- Hospital General Universitario de Valencia
- Yeovil District Hospital
- Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building
- Ninewells Hospital
- Edinburgh Cancer Research Centre Western General Hospital
- The Beatson West of Scotland Cancer Centre
- St James University Hospital
- Hammersmith Hospital
- Cancer Research UK & UCL Cancer Trials Center
- Nottingham University Hospitals NHS Trust
- Royal Marsden NHS Foundation Trust
- Clatterbridge Centre for Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Daily Phenoxodiol + weekly carboplatin
Daily phenoxodiol placebo + weekly carboplatin
Outcomes
Primary Outcome Measures
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death
Secondary Outcome Measures
The secondary efficacy end-point is overall survival (OS)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00382811
Brief Title
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
April 2009 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MEI Pharma, Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
142 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Daily Phenoxodiol + weekly carboplatin
Arm Title
2
Arm Type
Active Comparator
Arm Description
Daily phenoxodiol placebo + weekly carboplatin
Intervention Type
Drug
Intervention Name(s)
phenoxodiol
Intervention Description
400mg phenoxodiol three times daily in 28 day cycles.
Intervention Type
Drug
Intervention Name(s)
carboplatin
Intervention Description
AUC=2 weekly in 28 day cycles
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
every 8 hours daily in 28 day cycles
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
The secondary efficacy end-point is overall survival (OS)
Time Frame
Overall survival
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel P Gold, PhD
Organizational Affiliation
MEI Pharma, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Clinical Research Center, Inc.
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Glendale Adventist
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Gynecology Oncology Associates
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center)
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Gynecologic Oncology Associates
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Associates in Women's Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Hematology and Oncology Specialists, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Greater Baltimore Medical Centre
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Gynecologic Oncology of West Michigan
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49546
Country
United States
Facility Name
Providence Hospital and Medical Centers
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48075
Country
United States
Facility Name
The Center for Cancer & Hematological Disease
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08003
Country
United States
Facility Name
Jersey Shore Medical Center
City
Neptune
State/Province
New Jersey
ZIP/Postal Code
07754
Country
United States
Facility Name
The University of New Mexico Cancer Research and Treatment Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
Schwartz Gynecologic Oncology
City
Brightwaters
State/Province
New York
ZIP/Postal Code
11718
Country
United States
Facility Name
New York Downtown Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10038
Country
United States
Facility Name
University of Rochester Gynecologic Oncology Associates
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Brody School of Medical at East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Gabrail Cancer Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
OSU James Cancer Hospital & Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
Country
United States
Facility Name
Chattanooga GYN Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Chattanooga's Program In Women's Oncology
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Hall and Martin MDS, P.C.
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Hope Cancer Clinic
City
Brownsville
State/Province
Texas
ZIP/Postal Code
78526
Country
United States
Facility Name
University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Northern Virginia Pelvic Surgery Associates
City
Annadale
State/Province
Virginia
ZIP/Postal Code
22003
Country
United States
Facility Name
Virginia Mason Medical Center Department of Hematology/Oncology
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
Country
Australia
Facility Name
Royal North Shore Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
Country
Australia
Facility Name
Mater Adult Hospital
City
Brisbane
State/Province
Queensland
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
Country
Australia
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
IEO- Istituto Europeo di Oncologia
City
Milano
ZIP/Postal Code
20141
Country
Italy
Facility Name
Istitutio Fisioterapici Ospitaleri
City
Roma
ZIP/Postal Code
00144
Country
Italy
Facility Name
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie Oddzial Onkologii Ginekologicznej
City
Bialystok
ZIP/Postal Code
15-027
Country
Poland
Facility Name
Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku
City
Gdansk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach
City
Gliwice
ZIP/Postal Code
44-101
Country
Poland
Facility Name
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Oddzial w Krakowie Klinika Ginekologii Onkologicznej
City
Krakow
ZIP/Postal Code
31-115
Country
Poland
Facility Name
Centrum Onkologii Ziemi
City
Lublin
ZIP/Postal Code
20-090
Country
Poland
Facility Name
Ginekologiczno - Polozniczy Szpital Kliniczny AM im. K. Marcinkowskiego w Poznaniu SPZOZ Klinika Onkologii Ginekologicznej
City
Poznan
ZIP/Postal Code
60-535
Country
Poland
Facility Name
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Klinika Nowotworow Narzadow Plciowych Kobiecych
City
Warszawa
ZIP/Postal Code
02-781
Country
Poland
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital General Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic i Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital General Universitario de Valencia
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Yeovil District Hospital
City
Yeovil
State/Province
Somerset
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building
City
Birmingham
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Ninewells Hospital
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Facility Name
Edinburgh Cancer Research Centre Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XR
Country
United Kingdom
Facility Name
The Beatson West of Scotland Cancer Centre
City
Glasgow
ZIP/Postal Code
G12 0YH
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0HS
Country
United Kingdom
Facility Name
Cancer Research UK & UCL Cancer Trials Center
City
London
ZIP/Postal Code
W1T 4TJ
Country
United Kingdom
Facility Name
Nottingham University Hospitals NHS Trust
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust
City
Sutton
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Clatterbridge Centre for Oncology
City
Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
24318743
Citation
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.
Results Reference
derived
Learn more about this trial
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
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