Brief Title
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
Official 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
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.
Detailed Description
OBJECTIVES:
Primary
- Compare the safety and tolerability of phenoxodiol combined with 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.
- Compare, preliminarily, tumor response in patients treated with these regimens.
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1
of 2 treatment arms according to medical history.
- Arm I: Patients receive phenoxodiol IV over 10 minutes on days 1 and 2 and cisplatin IV
over 1 hour on day 2.
- Arm II: Patients receive phenoxodiol as in arm I and paclitaxel IV over 1 hour on day 2.
In both arms, treatment repeats every 6 weeks for up to 8 courses in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at 12, 24, 36, and 48 weeks or at the end of study participation.
Patients are followed at 6 and 12 months.
PROJECTED ACCRUAL: A total of 40 patients (20 per treatment arm) will be accrued for this
study.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
Safety and tolerability
Secondary Outcome
Surrogate marker of tumor response in terms of plasma protein tNOX
Condition
Fallopian Tube Cancer
Intervention
cisplatin
Study Arms / Comparison Groups
Arm A
Description: Phenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
65
Start Date
August 2004
Completion Date
March 2008
Primary Completion Date
December 2007
Eligibility 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
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Warren Lancaster, ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT00091377
Organization ID
CDR0000389129
Secondary IDs
NOVOGEN-NV06-037
Responsible Party
Sponsor
Study Sponsor
MEI Pharma, Inc.
Study Sponsor
Warren Lancaster, Study Chair, Kazia Therapeutics Limited
Verification Date
July 2016