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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00382811
Recruitment Status : Completed
First Posted : October 2, 2006
Last Update Posted : July 18, 2016
Information provided by (Responsible Party):
MEI Pharma, Inc.

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.

Condition or disease Intervention/treatment Phase
Fallopian Tube Cancer Peritoneal Neoplasms Ovarian Cancer Drug: phenoxodiol Drug: carboplatin Drug: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : October 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2011

Arm Intervention/treatment
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

Drug: placebo
every 8 hours daily in 28 day cycles

Primary Outcome Measures :
  1. 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 Measures :
  1. The secondary efficacy end-point is overall survival (OS) [ Time Frame: Overall survival ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00382811

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Sponsors and Collaborators
MEI Pharma, Inc.
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Study Director: Daniel P Gold, PhD MEI Pharma, Inc.

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: MEI Pharma, Inc. Identifier: NCT00382811     History of Changes
Other Study ID Numbers: NV06-0039
First Posted: October 2, 2006    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016

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:
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Ovarian Neoplasms
Carcinoma, Ovarian Epithelial
Fallopian Tube Neoplasms
Peritoneal Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Fallopian Tube Diseases
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Antineoplastic Agents