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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

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

September 28, 2006
February 23, 2012
October 2006
April 2009   (final data collection date for primary outcome measure)
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death. CT-scans will be obtained at time of screening and then after every 2nd treatment cycle (8 weeks).
Complete list of historical versions of study NCT00382811 on ClinicalTrials.gov Archive Site
The secondary efficacy end-point is overall survival (OS)
  • The secondary efficacy end-point is overall survival (OS).
  • The tertiary end-points are overall response rate, duration of response, clinical status (Karnofsky Performance Score), Quality of Life (QOL FACT-O and FACT-BRM).
Not Provided
Not Provided
 
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
  • Ovarian Cancer
  • Drug: phenoxodiol
    400mg phenoxodiol three times daily in 28 day cycles.
  • Drug: carboplatin
    AUC=2 weekly in 28 day cycles
  • Experimental: 1
    Daily Phenoxodiol + weekly carboplatin
    Interventions:
    • Drug: phenoxodiol
    • Drug: carboplatin
  • Active Comparator: 2
    Daily phenoxodiol placebo + weekly carboplatin
    Intervention: Drug: carboplatin
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
April 2011
April 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Belgium,   Italy,   Poland,   Spain,   United Kingdom
 
NCT00382811
NV06-0039
Not Provided
MEI Pharma, Inc.
MEI Pharma, Inc.
Not Provided
Study Director: Daniel P Gold, PhD MEI Pharma, Inc.
MEI Pharma, Inc.
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP