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Tracking Information | |||||
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First Received Date † | September 7, 2004 | ||||
Last Updated Date | July 23, 2008 | ||||
Start Date † | August 2004 | ||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00091377 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
Surrogate marker of tumor response in terms of plasma protein tNOX [ Designated as safety issue: No ] | ||||
Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | Phenoxodiol Combined With Either Cisplatin or Paclitaxel in Treating Patients With Recurrent Late-Stage Ovarian Epithelial, Fallopian Tube, or Primary Peritoneal Cancer | ||||
Official Title † | Multi-Center, Phase Ib/IIa Safety and Preliminary Efficacy Study of Phenoxodiol (Intravenous Dosage Form) as a Chemo-Sensitizing Agent for Cisplatin and Paclitaxel in Epithelial Ovarian Cancer or Primary Peritoneal Cancer That is 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. |
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Detailed Description | OBJECTIVES: Primary
OUTLINE: This is an open-label, randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms according to medical history.
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. |
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Study Phase | Phase I, Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Open Label | ||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Active, not recruiting | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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Gender | Female | ||||
Ages | 18 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States, Australia | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00091377 | ||||
Responsible Party | |||||
Secondary IDs †† | NOVOGEN-NV06-037, YALE-HIC-26423 | ||||
Study Sponsor † | Marshall Edwards, Inc | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||
Verification Date | August 2004 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |