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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00091377




Registration number
NCT00091377
Ethics application status
Date submitted
7/09/2004
Date registered
9/09/2004
Date last updated
14/07/2016

Titles & IDs
Public title
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Scientific title
Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer, Platinum- and/or Taxane-Refractory or Resistant
Secondary ID [1] 0 0
NOVOGEN-NV06-037
Secondary ID [2] 0 0
CDR0000389129
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fallopian Tube Cancer 0 0
Ovarian Cancer 0 0
Primary Peritoneal Cavity Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Ovarian and primary peritoneal
Cancer 0 0 0 0
Womb (Uterine or endometrial cancer)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - cisplatin
Treatment: Drugs - paclitaxel
Treatment: Drugs - phenoxodiol

Experimental: Arm A - Phenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles

Experimental: Arm B - Phenoxodiol IV 3 mg/kg combined with paclitaxel 80 mg/m2 on Day 2 6 week cycles


Treatment: Drugs: cisplatin
IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.

Treatment: Drugs: paclitaxel
IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.

Treatment: Drugs: phenoxodiol
IV 3 mg/kg
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability
Timepoint [1] 0 0
Average 6 mo
Primary outcome [2] 0 0
Efficacy
Timepoint [2] 0 0
Average 6 months
Secondary outcome [1] 0 0
Surrogate marker of tumor response in terms of plasma protein tNOX
Timepoint [1] 0 0
Average 6 months

Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:

* Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer

* Recurrent disease
* Received no more than 4 prior chemotherapy regimens for this malignancy

* Considered refractory or resistant to prior taxane (paclitaxel or docetaxel) and/or platinum (cisplatin or carboplatin) therapy based on 1 of the following criteria:

* Treatment-free interval < 6 months after platinum or paclitaxel
* Disease progression during platinum- or paclitaxel-based therapy
* Measurable or evaluable disease

* Measurable disease is defined as at least 1 unidimensionally measurable lesion = 20 mm by conventional techniques OR = 10 mm by spiral CT scan
* Evaluable disease is defined as doubling of CA 125 blood levels within the past 6 months AND CA 125 level = 2 times upper limit of normal (ULN) within the past week
* No active CNS metastases

* Patients with known CNS metastases must have received prior radiotherapy or CNS-directed chemotherapy AND have = 4 weeks of stable disease

PATIENT CHARACTERISTICS:

Age

* Over 18

Performance status

* Karnofsky 60-100%

Life expectancy

* At least 3 months

Hematopoietic

* Neutrophil count > 1,500/mm^3
* Platelet count > 100,000/mm^3
* WBC > 3,000/mm^3
* Hematocrit = 28% (transfusion or growth factors allowed)
* Hemoglobin > 8.0 g/dL (transfusion or growth factors allowed)

Hepatic

* Bilirubin = 1.5 times ULN
* SGOT = 2.5 times ULN
* Alkaline phosphatase = 2.5 times ULN

Renal

* Creatinine = 1.5 times ULN

Other

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No active infection requiring antibiotics
* No neuropathy (sensory or motor) > grade 1

PRIOR CONCURRENT THERAPY:

Biologic therapy

* No concurrent immunotherapy

Chemotherapy

* See Disease Characteristics
* No other concurrent chemotherapy

Endocrine therapy

* No concurrent hormonal therapy for the malignancy

Radiotherapy

* See Disease Characteristics
* No prior whole abdominal radiotherapy
* Concurrent localized radiotherapy allowed for control of local complications not indicative of general disease progression

Surgery

* Not specified

Other

* Recovered from prior antineoplastic therapy
* More than 4 weeks since prior standard therapy for malignant tumor
* More than 6 months since prior investigational anticancer drugs
* No other concurrent investigational drugs
* No concurrent drugs significantly metabolized by the cytochrome P450 enzymes CYP2C8, CYP2C9, CYP2C19, and CYP3A4/B1C
* No concurrent amifostine or other protective agents
* No concurrent grapefruit juice
Minimum age
18 Years
Maximum age
120 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2008
Sample size
Target
Accrual to date
Final
65
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Royal Women's Hospital - Carlton
Recruitment postcode(s) [1] 0 0
3053 - Carlton
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Connecticut

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
MEI Pharma, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
RATIONALE: Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Phenoxodiol may help cisplatin and paclitaxel kill more tumor cells by making tumor cells more sensitive to the drugs.

PURPOSE: This randomized phase I/II trial is studying the side effects of phenoxodiol when given together with either cisplatin or paclitaxel and to see how well they work in treating patients with recurrent late-stage ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer that has not responded to treatment with drugs such as paclitaxel, docetaxel, cisplatin, or carboplatin.
Trial website
https://clinicaltrials.gov/study/NCT00091377
Trial related presentations / publications
Kelly MG, Mor G, Husband A, O'Malley DM, Baker L, Azodi M, Schwartz PE, Rutherford TJ. Phase II evaluation of phenoxodiol in combination with cisplatin or paclitaxel in women with platinum/taxane-refractory/resistant epithelial ovarian, fallopian tube, or primary peritoneal cancers. Int J Gynecol Cancer. 2011 May;21(4):633-9. doi: 10.1097/IGC.0b013e3182126f05.
Public notes

Contacts
Principal investigator
Name 0 0
Warren Lancaster
Address 0 0
Kazia Therapeutics Limited
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00091377