None listed
Conditions
Interventions
Phenoxodiol intravenous and oral dosage formulations in combination with cisplatin, carboplatin or paclitaxel. The duration is for a maximum of 8 x 6 week treatment cycles (48 weeks).
Sponsors
Marshall Edwards Pty Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
a) Patients must have histological evidence of epithelial ovarian, fallopian or primary peritoneal carcinoma and have been previously surgically stagedb) Patients must have received less than or equal to 4 prior chemotherapy regimens for this malignancyc) Patients must have been treated previously with a taxane (paclitaxel or taxotere) and/or platinum (cisplatin or carboplatin) and be considered refractory or resistant to either or both therapies based on the following: have had a treatment free interval following platinum or paclitaxel of less than 6 months or have progressed during platinum or paclitaxel-based therapy.d) Patients must have either measurable or evaluable disease by the following criteria:Measurable disease is defined as having at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded) allowing a response to be determined by the RECIST criteria. Each lesion must be greater than 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or greater 10 mm when measured by spiral CT. Patients with evaluable disease must have experienced doubling of blood levels of CA125 in the six (6) months leading up to enrollment in the study and have a CA125 level at least two times greater than the institutional upper limit of normal values, within 1 week of study entry.e) Patients must be > 18 years of age and must be able to understand the risks and benefits of the study and to be able to give written informed consent to participationf) Patients must have a Karnofsky Performance Score of at least 60%g) Patients must be off any standard therapy directed at the malignant tumor for at least 4 weeks, and in the case of any investigational anti-cancer drugs, for at least 6 monthsh) Patients should be free of active infection requiring antibioticsi) Patients of childbearing potential must have a negative serum pregnancy test prior to study entry and be practicing an effective form of contraceptionj) Patients must have; Renal function: creatinine levels less than 1.5 x institutional upper limit normal (ULN) (equivalent to Common Toxicity Criteria (CTC) Grade 1)Hepatic function: bilirubin levels less than 1.5 x ULN (CTC Grade 1); SGOT and alkaline phosphatase less than 2.5 x ULN (CTC Grade 1)Bone marrow function: platelets > 100x109/L , WCC > 3x109/L, Hb > 8g/dL, neutrophils > 1.5 x 109 /LNeurological function: neuropathy (sensory and motor) less than or equal to CTC Grade 1.k) Patients must have signed an approved informed consent.
Exclusion criteria
No exclusion criteria
Outcome results
None listed