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Sponsors and Collaborators: |
Yale University National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00303888 |
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Phenoxodiol may help docetaxel work better by making tumor cells more sensitive to the drug.
PURPOSE: This randomized phase I/II trial is studying the side effects of docetaxel when given together with either phenoxodiol or placebo and to see how well it works in treating patients with recurrent advanced ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: docetaxel Drug: phenoxodiol Other: placebo |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control |
Official Title: | A Randomized Placebo-Controlled Phase Ib/IIa Safety, Tolerability and Efficacy Study of Oral Phenoxodiol in Combination With Docetaxel Versus Docetaxel Alone in Patients With Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer |
Estimated Enrollment: | 60 |
Study Start Date: | April 2006 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive docetaxel IV over 1 hour on days 1, 8, and 15 and oral placebo three times daily on days 1-21.
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Drug: docetaxel
Given IV
Other: placebo
Given orally
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Arm II: Experimental
Patients receive oral phenoxodiol three times daily on days 1-21 and docetaxel IV over 1 hour on days 1, 8, and 15.
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Drug: docetaxel
Given IV
Drug: phenoxodiol
Given orally
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OBJECTIVES:
Primary
Secondary
OUTLINE: This is a randomized, placebo-controlled, double-blind study. Patients are randomized to 1 of 2 treatment arms.
Treatment in both arms repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed monthly for 6 months, every 3 months for 1 year, and then annually thereafter.
PROJECTED ACCRUAL: A total of 60 patients 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 diagnosis of 1 of the following:
Recurrent advanced disease
Received platinum and taxane combination chemotherapy as first-line treatment with disease recurrence > 6 months after conclusion of therapy
Meets 1 of the following criteria:
No active CNS metastases
PATIENT CHARACTERISTICS:
Relative proportions of AST, ALT, and alkaline phosphatase according 1 to the following criteria:
PRIOR CONCURRENT THERAPY:
No other concurrent chemotherapy, radiotherapy, immunotherapy, or hormonal antitumor therapy
United States, Connecticut | |
Yale Cancer Center | Recruiting |
New Haven, Connecticut, United States, 06520-8028 | |
Contact: Clinical Trials Office - Yale Cancer Center 203-785-5702 |
Principal Investigator: | Thomas J. Rutherford, MD, PhD | Yale University |
Study ID Numbers: | CDR0000462103, YALE-HIC-27640, YALE-012705 |
Study First Received: | March 15, 2006 |
Last Updated: | June 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00303888 History of Changes |
Health Authority: | Unspecified |
recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer stage III ovarian epithelial cancer stage IV ovarian epithelial cancer |
Fallopian Tube Cancer Digestive System Neoplasms Ovarian Neoplasms Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Ovarian Epithelial Cancer Abdominal Neoplasms Fallopian Tube Neoplasms |
Recurrence Docetaxel Genital Diseases, Female Digestive System Diseases Peritoneal Diseases Ovarian Cancer Gastrointestinal Neoplasms Endocrinopathy Peritoneal Neoplasms Endocrine Gland Neoplasms |
Digestive System Neoplasms Ovarian Neoplasms Antineoplastic Agents Gonadal Disorders Genital Neoplasms, Female Endocrine System Diseases Urogenital Neoplasms Ovarian Diseases Abdominal Neoplasms Pharmacologic Actions Fallopian Tube Neoplasms |
Fallopian Tube Diseases Adnexal Diseases Docetaxel Genital Diseases, Female Neoplasms Digestive System Diseases Neoplasms by Site Therapeutic Uses Peritoneal Diseases Peritoneal Neoplasms Endocrine Gland Neoplasms |