OVATURE (OVArian TUmor REsponse) study

INTERVENTION: Intervention group The Phenoxodiol oral dose will be 2x200mg capsules taken 8 hourly (three times per day). Patients will receive carboplatin at a dosage of (Area Under the Curve) AUC=2, administered by intravenous injection once a week. Carboplatin will be administered weekly as a change in regimen from 3‐weekly to weekly has been shown with taxanes to provide tumor response in patients whose tumors have become resistant to a 3‐weekly regimen. The OVATURE study will compare Phenoxodiol (in the oral dosage form) combined with Carboplatin against Placebo combined with Carboplatin. The duration of each treatment cycle will be 4 weeks and there is no limit to the number of treatment cycles that can be administered. The expected overall trial completion date is March 2010. Treatment cycles will be discontinued in the case of unacceptable toxicity, disease progression, patient voluntary withdrawal, or if the Investigator or Sponsor asks for the patient to be withdrawn. CONDITION: Epithelial ovarian, fallopian or primary peritoneal cancer that is resistant or refractory to 2‐weekly, 3‐ or 4‐weekly platinum drug therapy PRIMARY OUTCOME: Drug‐associated toxicity and intolerance Progression‐free survival (PFS) SECONDARY OUTCOME: Clinical status evaluated by Karnofsky Performance Score Duration of response Quality of life Secondary Efficacy: Overall survival Tertiary Efficacy: Overall response rate INCLUSION CRITERIA: 1) histologically‐confirmed ovarian, fallopian, or primary peritoneal carcinoma of epithelial origin; 2) recurrent or persistent advanced disease; 3) have measurable disease; 4) Treatment response history; 5) 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 RECIST or GCIG criteria; 6)shown 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 have a platinum‐free interval of no greater than 6 months at the time of enrollment; 7) can have any number of previous courses of platinum therapy or non‐platinum therapy; 8) be considered likely to survive at least 3 months; 9) have a Karnofsky Performance Score of at least 60%; 10) have adequate physiological function without evidence of major organ dysfunction; 11) have adeq