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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Fallopian Tube Cancer, Peritoneal Neoplasms, Ovarian Cancer

Intervention / Treatment
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* Drug: phenoxodiol
* Drug: carboplatin
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Daily Phenoxodiol + weekly carboplatin | Drug: phenoxodiol<br>* 400mg phenoxodiol three times daily in 28 day cycles.<br>Drug: carboplatin<br>* AUC=2 weekly in 28 day cycles<br>|
| Active Comparator: 2<br>Daily phenoxodiol placebo + weekly carboplatin | Drug: carboplatin<br>* AUC=2 weekly in 28 day cycles<br>Drug: placebo<br>* every 8 hours daily in 28 day cycles<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy end-point is progression-free survival (PFS). PFS is the time from randomization until disease progression or death |  | Progression Free Survival | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary efficacy end-point is overall survival (OS) |  | Overall survival | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent Ovarian Epithelial Cancer, Stage IV Ovarian Epithelial Cancer, Peritoneal Cavity Cancer, Stage III Ovarian Epithelial Cancer