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

Completed · Phase 3 · Has a placebo group

Conditions studied: Fallopian Tube Cancer, Peritoneal Neoplasms, Ovarian Cancer

In brief

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.

Key facts

Study ID

NCT00382811

Run by

MEI Pharma, Inc.

People needed

142

Starts

2006-10-01

Expected to finish

2011-04-01

Last updated by the study team

2016-07-18

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Glendale Adventist — Glendale, California, United States
• Kaiser Permanente Los Angeles Medical Center — Los Angeles, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Gynecology Oncology Associates — Newport Beach, California, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Hematology Oncology, PC (Carl and Dorothy Bennett Cancer Center) — Stamford, Connecticut, United States
• Gynecologic Oncology Associates — Pembroke Pines, Florida, United States
• Piedmont Hospital — Atlanta, Georgia, United States
• Medical College of Georgia Cancer Center — Augusta, Georgia, United States
• Associates in Women's Health — Wichita, Kansas, United States
• Hematology and Oncology Specialists, LLC — Metairie, Louisiana, United States
• Greater Baltimore Medical Centre — Baltimore, Maryland, United States
• Gynecologic Oncology of West Michigan — Grand Rapids, Michigan, United States
• Providence Hospital and Medical Centers — Southfield, Michigan, United States
• The Center for Cancer & Hematological Disease — Cherry Hill, New Jersey, United States
• Jersey Shore Medical Center — Neptune City, New Jersey, United States
• The University of New Mexico Cancer Research and Treatment Center — Albuquerque, New Mexico, United States
• Schwartz Gynecologic Oncology — Brightwaters, New York, United States
• New York Downtown Hospital — New York, New York, United States
• University of Rochester Gynecologic Oncology Associates — Rochester, New York, United States
• Carolinas Medical Center — Charlotte, North Carolina, United States
• Brody School of Medical at East Carolina University — Greenville, North Carolina, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Gabrail Cancer Center — Canton, Ohio, United States
• Arizona Clinical Research Center, Inc. — Tuscon, Arizona, United States

Full record on ClinicalTrials.gov

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