Brief Title
OVATURE (OVArian TUmor REsponse) A Phase III Study of Weekly Carboplatin With and Without Phenoxodiol in Patients With Platinum-Resistant, Recurrent Epithelial Ovarian Cancer
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
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death
Secondary Outcome
The secondary efficacy end-point is overall survival (OS)
Condition
Fallopian Tube Cancer
Intervention
phenoxodiol
Study Arms / Comparison Groups
1
Description: Daily Phenoxodiol + weekly carboplatin
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
142
Start Date
October 2006
Completion Date
April 2011
Primary Completion Date
April 2009
Eligibility 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.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Daniel P Gold, PhD, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00382811
Organization ID
NV06-0039
Responsible Party
Sponsor
Study Sponsor
MEI Pharma, Inc.
Study Sponsor
Daniel P Gold, PhD, Study Director, MEI Pharma, Inc.
Verification Date
July 2016