- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00091377
Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Patients With Recurrent Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer
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
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Victoria
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Carlton, Victoria, Australia, 3053
- Royal Women's Hospital
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-
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Connecticut
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New Haven, Connecticut, United States, 06520-8028
- Yale Comprehensive Cancer Center at Yale University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A
Phenoxodiol IV 3 mg/kg combined with cisplatin 40 mg/m2 on Day 2 6 week cycles
|
IV 40 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
IV 3 mg/kg
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Experimental: Arm B
Phenoxodiol IV 3 mg/kg combined with paclitaxel 80 mg/m2 on Day 2 6 week cycles
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IV 3 mg/kg
IV 80 mg/m2 on Day 2 Number of Cycles: until progression or unacceptable toxicity or other withdrawal criteria are met.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety and tolerability
Time Frame: Average 6 mo
|
Average 6 mo
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Efficacy
Time Frame: Average 6 months
|
Average 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Surrogate marker of tumor response in terms of plasma protein tNOX
Time Frame: Average 6 months
|
Average 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Warren Lancaster, Kazia Therapeutics Limited
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Carcinoma
- Neoplasms, Glandular and Epithelial
- Genital Neoplasms, Female
- Endocrine System Diseases
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Endocrine Gland Neoplasms
- Fallopian Tube Diseases
- Ovarian Neoplasms
- Fallopian Tube Neoplasms
- Carcinoma, Ovarian Epithelial
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
- Cisplatin
Other Study ID Numbers
- CDR0000389129
- NOVOGEN-NV06-037
- YALE-HIC-26423
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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