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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MEI Pharma, Inc.
ClinicalTrials.gov Identifier:
NCT00382811
First received: September 28, 2006
Last updated: February 23, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention Phase
Fallopian Tube Cancer
Peritoneal Neoplasms
Ovarian Cancer
Drug: phenoxodiol
Drug: carboplatin
Phase 3

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

Resource links provided by NLM:


Further study details as provided by MEI Pharma, Inc.:

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)

Enrollment: 142
Study Start Date: October 2006
Study Completion Date: April 2011
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Daily Phenoxodiol + weekly carboplatin
Drug: phenoxodiol
400mg phenoxodiol three times daily in 28 day cycles.
Drug: carboplatin
AUC=2 weekly in 28 day cycles
Active Comparator: 2
Daily phenoxodiol placebo + weekly carboplatin
Drug: carboplatin
AUC=2 weekly in 28 day cycles

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00382811

  Hide Study Locations
Locations
United States, Arizona
Arizona Clinical Research Center, Inc.
Tuscon, Arizona, United States, 85715
United States, California
Glendale Adventist
Glendale, California, United States, 91206
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, United States, 90027
Gynecology Oncology Associates
Newport Beach, California, United States, 92663
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center)
Stamford, Connecticut, United States, 06902
United States, Florida
Gynecologic Oncology Associates
Pembroke Pines, Florida, United States, 33028
United States, Georgia
Piedmont Hospital
Atlanta, Georgia, United States, 30309
Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
United States, Kansas
Associates in Women's Health
Wichita, Kansas, United States, 67214
United States, Louisiana
Hematology and Oncology Specialists, LLC
Metairie, Louisiana, United States, 70006
United States, Maryland
Greater Baltimore Medical Centre
Baltimore, Maryland, United States, 21204
United States, Michigan
Gynecologic Oncology of West Michigan
Grand Rapids, Michigan, United States, 49546
Providence Hospital and Medical Centers
Southfield, Michigan, United States, 48075
United States, New Jersey
The Center for Cancer & Hematological Disease
Cherry Hill, New Jersey, United States, 08003
Jersey Shore Medical Center
Neptune, New Jersey, United States, 07754
United States, New Mexico
The University of New Mexico Cancer Research and Treatment Center
Albuquerque, New Mexico, United States, 87131-0001
United States, New York
Schwartz Gynecologic Oncology
Brightwaters, New York, United States, 11718
New York Downtown Hospital
New York, New York, United States, 10038
University of Rochester Gynecologic Oncology Associates
Rochester, New York, United States, 14620
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28204
Brody School of Medical at East Carolina University
Greenville, North Carolina, United States, 27834
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Gabrail Cancer Center
Canton, Ohio, United States, 44718
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
OSU James Cancer Hospital & Solove Research Institute
Columbus, Ohio, United States, 43210
Miami Valley Hospital
Dayton, Ohio, United States
United States, Tennessee
Chattanooga GYN Oncology
Chattanooga, Tennessee, United States, 37403
Chattanooga's Program In Women's Oncology
Chattanooga, Tennessee, United States, 37403
Hall and Martin MDS, P.C.
Knoxville, Tennessee, United States, 37920
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Hope Cancer Clinic
Brownsville, Texas, United States, 78526
University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center
Dallas, Texas, United States, 75390
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Virginia
Northern Virginia Pelvic Surgery Associates
Annadale, Virginia, United States, 22003
United States, Washington
Virginia Mason Medical Center Department of Hematology/Oncology
Seattle, Washington, United States, 98101
Australia, New South Wales
Prince of Wales Hospital
Randwick, New South Wales, Australia
Royal North Shore Hospital
Sydney, New South Wales, Australia, 2065
Westmead Hospital
Westmead, New South Wales, Australia
Australia, Queensland
Mater Adult Hospital
Brisbane, Queensland, Australia
Australia, South Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Belgium
UZ Antwerpen
Edegem, Belgium, 2650
UZ Leuven
Leuven, Belgium, 3000
Italy
IEO- Istituto Europeo di Oncologia
Milano, Italy, 20141
Istitutio Fisioterapici Ospitaleri
Roma, Italy, 00144
Poland
Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie Oddzial Onkologii Ginekologicznej
Bialystok, Poland, 15-027
Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku
Gdansk, Poland, 80-402
Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach
Gliwice, Poland, 44-101
Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Oddzial w Krakowie Klinika Ginekologii Onkologicznej
Krakow, Poland, 31-115
Centrum Onkologii Ziemi
Lublin, Poland, 20-090
Ginekologiczno - Polozniczy Szpital Kliniczny AM im. K. Marcinkowskiego w Poznaniu SPZOZ Klinika Onkologii Ginekologicznej
Poznan, Poland, 60-535
Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Klinika Nowotworow Narzadow Plciowych Kobiecych
Warszawa, Poland, 02-781
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital General Universitario de Alicante
Alicante, Spain, 03010
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain, 08036
Hospital del Mar
Barcelona, Spain, 08003
Hospital General Vall d'Hebron
Barcelona, Spain, 08035
Hospital General Universitario de Valencia
Valencia, Spain, 46014
United Kingdom
Yeovil District Hospital
Yeovil, Somerset, United Kingdom, BA21 4AT
Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building
Birmingham, United Kingdom, B18 7QH
Ninewells Hospital
Dundee, United Kingdom, DD1 9SY
Edinburgh Cancer Research Centre Western General Hospital
Edinburgh, United Kingdom, EH4 2XR
The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom, G12 0YH
St James University Hospital
Leeds, United Kingdom, LS9 7TF
Cancer Research UK & UCL Cancer Trials Center
London, United Kingdom, W1T 4TJ
Hammersmith Hospital
London, United Kingdom, W12 0HS
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom, SM2 5PT
Clatterbridge Centre for Oncology
Wirral, United Kingdom, CH63 4JY
Sponsors and Collaborators
MEI Pharma, Inc.
Investigators
Study Director: Daniel P Gold, PhD MEI Pharma, Inc.
  More Information

Additional Information:
No publications provided by MEI Pharma, Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: MEI Pharma, Inc.
ClinicalTrials.gov Identifier: NCT00382811     History of Changes
Other Study ID Numbers: NV06-0039
Study First Received: September 28, 2006
Last Updated: February 23, 2012
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by MEI Pharma, Inc.:
Recurrent Ovarian Epithelial Cancer
Stage IV Ovarian Epithelial Cancer
Peritoneal Cavity Cancer
Stage III Ovarian Epithelial Cancer

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014