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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Daily Phenoxodiol + weekly carboplatin |
|
| 2 | Active Comparator | Daily phenoxodiol placebo + weekly carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| phenoxodiol | Drug | 400mg phenoxodiol three times daily in 28 day cycles. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death | Progression Free Survival |
| Measure | Description | Time Frame |
|---|---|---|
| The secondary efficacy end-point is overall survival (OS) | Overall survival |
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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:
Have adequate hematological function defined by:
Aged > 18
Be able to understand the risks and benefits of the study and give written informed consent to participation.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daniel P Gold, PhD | MEI Pharma, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Clinical Research Center, Inc. | Tuscon | Arizona | 85715 | United States | ||
| Glendale Adventist |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24318743 | Derived | 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. |
| Label | URL |
|---|---|
| Click here for more information on the study and sponsor. | View source |
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| carboplatin |
| Drug |
AUC=2 weekly in 28 day cycles |
|
| placebo | Drug | every 8 hours daily in 28 day cycles |
|
| Glendale |
| California |
| 91206 |
| United States |
| Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | United States |
| Cedars-Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Gynecology Oncology Associates | Newport Beach | California | 92663 | United States |
| Yale University School of Medicine | New Haven | Connecticut | 06520 | United States |
| Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center) | Stamford | Connecticut | 06902 | United States |
| Gynecologic Oncology Associates | Pembroke Pines | Florida | 33028 | United States |
| Piedmont Hospital | Atlanta | Georgia | 30309 | United States |
| Medical College of Georgia Cancer Center | Augusta | Georgia | 30912 | United States |
| Associates in Women's Health | Wichita | Kansas | 67214 | United States |
| Hematology and Oncology Specialists, LLC | Metairie | Louisiana | 70006 | United States |
| Greater Baltimore Medical Centre | Baltimore | Maryland | 21204 | United States |
| Gynecologic Oncology of West Michigan | Grand Rapids | Michigan | 49546 | United States |
| Providence Hospital and Medical Centers | Southfield | Michigan | 48075 | United States |
| The Center for Cancer & Hematological Disease | Cherry Hill | New Jersey | 08003 | United States |
| Jersey Shore Medical Center | Neptune City | New Jersey | 07754 | United States |
| The University of New Mexico Cancer Research and Treatment Center | Albuquerque | New Mexico | 87131-0001 | United States |
| Schwartz Gynecologic Oncology | Brightwaters | New York | 11718 | United States |
| New York Downtown Hospital | New York | New York | 10038 | United States |
| University of Rochester Gynecologic Oncology Associates | Rochester | New York | 14620 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | United States |
| Brody School of Medical at East Carolina University | Greenville | North Carolina | 27834 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| Gabrail Cancer Center | Canton | Ohio | 44718 | United States |
| MetroHealth Medical Center | Cleveland | Ohio | 44109 | United States |
| OSU James Cancer Hospital & Solove Research Institute | Columbus | Ohio | 43210 | United States |
| Miami Valley Hospital | Dayton | Ohio | United States |
| Chattanooga GYN Oncology | Chattanooga | Tennessee | 37403 | United States |
| Chattanooga's Program In Women's Oncology | Chattanooga | Tennessee | 37403 | United States |
| Hall and Martin MDS, P.C. | Knoxville | Tennessee | 37920 | United States |
| Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Hope Cancer Clinic | Brownsville | Texas | 78526 | United States |
| University of Texas Southwestern Medical Center Simmons Comprehensive Cancer Center | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| Northern Virginia Pelvic Surgery Associates | Annadale | Virginia | 22003 | United States |
| Virginia Mason Medical Center Department of Hematology/Oncology | Seattle | Washington | 98101 | United States |
| Prince of Wales Hospital | Randwick | New South Wales | Australia |
| Royal North Shore Hospital | Sydney | New South Wales | 2065 | Australia |
| Westmead Hospital | Westmead | New South Wales | Australia |
| Mater Adult Hospital | Brisbane | Queensland | Australia |
| Royal Adelaide Hospital | Adelaide | South Australia | Australia |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| UZ Leuven | Leuven | 3000 | Belgium |
| IEO- Istituto Europeo di Oncologia | Milan | 20141 | Italy |
| Istitutio Fisioterapici Ospitaleri | Roma | 00144 | Italy |
| Bialostockie Centrum Onkologii im. Marii Sklodowskiej-Curie Oddzial Onkologii Ginekologicznej | Bialystok | 15-027 | Poland |
| Ackademickie Centrum Kliniczne-Szpital, Akademii Medycznej w Gdansku | Gdansk | 80-402 | Poland |
| Centrum Onkologii-Instytut im. M. Sklodowskiej-Curie, Oddzial w Gliwicach | Gliwice | 44-101 | Poland |
| Centrum Onkologii - Instytut im. M. Sklodowskiej-Curie Oddzial w Krakowie Klinika Ginekologii Onkologicznej | Krakow | 31-115 | Poland |
| Centrum Onkologii Ziemi | Lublin | 20-090 | Poland |
| Ginekologiczno - Polozniczy Szpital Kliniczny AM im. K. Marcinkowskiego w Poznaniu SPZOZ Klinika Onkologii Ginekologicznej | Poznan | 60-535 | Poland |
| Centrum Onkologii-Instytut im. M. Sklodowskiej Curie Klinika Nowotworow Narzadow Plciowych Kobiecych | Warsaw | 02-781 | Poland |
| Hospital Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital del Mar | Barcelona | Barcelona | 08003 | Spain |
| Hospital General Universitario de Alicante | Alicante | 03010 | Spain |
| Hospital General Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic i Provincial de Barcelona | Barcelona | 08036 | Spain |
| Hospital General Universitario de Valencia | Valencia | 46014 | Spain |
| Yeovil District Hospital | Yeovil | Somerset | BA21 4AT | United Kingdom |
| Cancer Research UK Clinical Trials Unit Old Clinical Investigations Building | Birmingham | B18 7QH | United Kingdom |
| Ninewells Hospital | Dundee | DD1 9SY | United Kingdom |
| Edinburgh Cancer Research Centre Western General Hospital | Edinburgh | EH4 2XR | United Kingdom |
| The Beatson West of Scotland Cancer Centre | Glasgow | G12 0YH | United Kingdom |
| St James University Hospital | Leeds | LS9 7TF | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| Cancer Research UK & UCL Cancer Trials Center | London | W1T 4TJ | United Kingdom |
| Clatterbridge Centre for Oncology | Metropolitan Borough of Wirral | CH63 4JY | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| Royal Marsden NHS Foundation Trust | Sutton | SM2 5PT | United Kingdom |
| ID | Term |
|---|---|
| D005185 | Fallopian Tube Neoplasms |
| D010534 | Peritoneal Neoplasms |
| D010051 | Ovarian Neoplasms |
| D000077216 | Carcinoma, Ovarian Epithelial |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005184 | Fallopian Tube Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D000008 | Abdominal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D010532 | Peritoneal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C471183 | phenoxodiol |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
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