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Sponsored by: |
Marshall Edwards, Inc |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00091377 |
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.
Condition | Intervention | Phase |
---|---|---|
Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: cisplatin Drug: paclitaxel Drug: phenoxodiol |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
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 |
Study Start Date: | August 2004 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cancer
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:
Measurable or evaluable disease
No active CNS metastases
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, Connecticut | |
Yale Comprehensive Cancer Center at Yale University School of Medicine | |
New Haven, Connecticut, United States, 06520-8028 | |
Australia, Victoria | |
Royal Women's Hospital | |
Carlton, Victoria, Australia, 3053 |
Investigator: | Warren Lancaster | Novogen |
Study ID Numbers: | CDR0000389129, NOVOGEN-NV06-037, YALE-HIC-26423 |
Study First Received: | September 7, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00091377 History of Changes |
Health Authority: | United States: Federal Government |
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Fallopian Tube Cancer Gonadal Disorders Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Cisplatin Peritoneal Diseases Ovarian Cancer Taxane Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Genital Neoplasms, Female Endocrine System Diseases |
Antimitotic Agents Abdominal Neoplasms Ovarian Epithelial Cancer Recurrence Fallopian Tube Neoplasms Fallopian Tube Diseases Digestive System Diseases Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Gastrointestinal Neoplasms Peritoneal Neoplasms Endocrinopathy Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Gonadal Disorders Antineoplastic Agents Physiological Effects of Drugs Urogenital Neoplasms Ovarian Diseases Genital Diseases, Female Neoplasms by Site Cisplatin Therapeutic Uses Peritoneal Diseases Endocrine Gland Neoplasms Ovarian Neoplasms Digestive System Neoplasms Mitosis Modulators |
Genital Neoplasms, Female Endocrine System Diseases Antimitotic Agents Abdominal Neoplasms Fallopian Tube Neoplasms Pharmacologic Actions Adnexal Diseases Fallopian Tube Diseases Neoplasms Digestive System Diseases Radiation-Sensitizing Agents Paclitaxel Tubulin Modulators Peritoneal Neoplasms Antineoplastic Agents, Phytogenic |