Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000432617
Ethics application status
Approved
Date submitted
12/09/2005
Date registered
16/09/2005
Date last updated
9/12/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous Dosage Form and Oral Dosage Form) as a Chemo-Sensitizing Agent for Cisplatin, Carboplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer that is Platinum- and/or Taxane-Refractory or Resistant.
Scientific title
Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous Dosage Form and Oral Dosage Form) as a Chemo-Sensitizing Agent for Cisplatin, Carboplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer that is Platinum- and/or Taxane-Refractory or Resistant.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent, late-stage epithelial ovarian cancer or primary peritoneal cancer that is refractory or resistant to taxanes and/or platinums. 542 0
Condition category
Condition code
Cancer 621 621 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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).
Intervention code [1] 468 0
Treatment: Drugs
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 726 0
Compare the safety and tolerability of phenoxodiol combined with carboplatin, cisplatin or paclitaxel in patients with recurrent late-stage ovarian epithelial, fallopian tube, or primary peritoneal cancer that is refractory or resistant to platinum and/or taxane drugs.
Timepoint [1] 726 0
Adverse events and blood parameters are assessed weekly.
Primary outcome [2] 727 0
Compare, preliminarily, tumor response in patients treated with the regimens phenoxodiol combined with carboplatin, cisplatin or paclitaxel.
Timepoint [2] 727 0
Performed at baseline, end of cycle 1, 3, 5 and 6 or when withdrawn.
Secondary outcome [1] 1492 0
To evaluate the plasma protein, tNOX, as a surrogate marker of tumor response.
Timepoint [1] 1492 0
Blood is collected every two weeks to assess the effect on tNOX levels.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
Not stated
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Randomisation by fax.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random number table in blocks
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/04/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 679 0
Commercial sector/Industry
Name [1] 679 0
Marshall Edwards Pty Ltd
Country [1] 679 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Marshall Edwards Pty Ltd
Address
Country
Australia
Secondary sponsor category [1] 568 0
None
Name [1] 568 0
Not applicable
Address [1] 568 0
Country [1] 568 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35569 0
Address 35569 0
Country 35569 0
Phone 35569 0
Fax 35569 0
Email 35569 0
Contact person for public queries
Name 9657 0
Amanda Marshall
Address 9657 0
Royal Womens Hospital
132 Grattan Street
Carlton VIC 3053
Country 9657 0
Australia
Phone 9657 0
+61 3 93442988
Fax 9657 0
Email 9657 0
[email protected]
Contact person for scientific queries
Name 585 0
Amanda Marshall
Address 585 0
Royal Womens Hospital
132 Grattan Street
Carlton VIC 3053
Country 585 0
Australia
Phone 585 0
+61 3 93442988
Fax 585 0
Email 585 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.