None listed
Conditions
Brief summary
The OVATURE study will compare the investigational drug Phenoxodiol combined with the chemotherapy drug Carboplatin against a placebo combined with Carboplatin. It is hypothesised that Phenoxodiol will reverse chemo-resistance to platinum drugs in late stage ovarian, fallopian and primary peritoneal cancers. For more information on the study and sponsor go to http://www.marshalledwardsinc.com/ or www.phenoxodiol.com
Interventions
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
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disease progression, patient voluntary withdrawal, or if the Investigator or Sponsor asks for the patient to be withdrawn.
Sponsors
Marshall Edwards Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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 adequate hematological function defined by platelets > 100,000/ mm3, WCC > 3,000/mm3, neutrophils > 1,500 /mm3, hemoglobin more than or equal to 8.0 g/dl; 12) Have a negative pregnancy test (HCG) in patients of childbearing potential 13) be aged 18 or older and be able to understand the risks and benefits of the study and give written informed consent to participation.
Exclusion criteria
1) patients with mucinous histological type of ovarian cancer; 2) patients who have failed to show a clinical response (RECIST or GCIG criteria) to at least one prior course of platinum therapy; 3) patients with active infection; 4) patients with concurrent severe and/or uncontrolled medical disease (e.g., uncontrolled diabetes, hypertension, ischemic heart disease, congestive heart failure, etc.); 5) patients with a history of chronic active hepatitis or cirrhosis; 6) patients with HIV; 7) patients with active CNS metastases. Patients with known CNS metastases must have received prior radiation therapy, and CNS metastatic disease must be stable for 4 weeks; 8) patients who have not recovered from the acute effects of any prior anti-neoplastic therapy; 9) and patients with known hypersensitivity to platinum drugs drugs that can not be managed with concomitant medication.
Outcome results
None listed