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

  Show 70 Study Locations
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