Clinical trial NCT00382811: OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
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
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: MEI Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2006-10-02
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

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