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Sponsors and Collaborators: |
Gynecologic Oncology Group National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00041080 |
RATIONALE: Estrogen can stimulate the growth of some types of cancer cells. Hormone therapy using tamoxifen may fight cancer by blocking the uptake of estrogen. Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. It is not yet known whether thalidomide is more effective than tamoxifen in treating ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of tamoxifen with that of thalidomide in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Condition | Intervention | Phase |
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Fallopian Tube Cancer Ovarian Cancer Peritoneal Cavity Cancer |
Drug: tamoxifen citrate Drug: thalidomide |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | A Randomized Study Of Tamoxifen Versus Thalidomide (NSC# 66847) In Patients With Biochemical-Recurrence-Only Epithelial Ovarian Cancer, Cancer Of The Fallopian Tube, And Primary Peritoneal Carcinoma After First Line Chemotherapy |
Estimated Enrollment: | 260 |
Study Start Date: | February 2003 |
Arms | Assigned Interventions |
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Arm I: Experimental
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
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Drug: thalidomide
Given orally
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Arm II: Active Comparator
Patients receive oral tamoxifen twice daily on days 1-28. Courses repeat every 28 days for up to 1 year in the absence of disease progression or unacceptable toxicity.
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Drug: tamoxifen citrate
Given orally
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OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to the interval between completion of front-line chemotherapy and appearance of biochemical progression (6 months or less vs more than 6 months). Patients are randomized to 1 of 2 treatment arms.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 260 patients will be accrued for this study within 6.5 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Clinically and radiologically without evidence of measurable and nonmeasurable disease
Must have a biochemical recurrence
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Illinois | |
Carle Cancer Center at Carle Foundation Hospital | |
Urbana, Illinois, United States, 61801 | |
CCOP - Carle Cancer Center | |
Urbana, Illinois, United States, 61801 | |
Joliet Oncology-Hematology Associates, Limited - West | |
Joliet, Illinois, United States, 60435 | |
United States, Indiana | |
Saint Anthony Memorial Health Centers | |
Michigan City, Indiana, United States, 46360 | |
United States, Kentucky | |
James Graham Brown Cancer Center at University of Louisville | |
Louisville, Kentucky, United States, 40202 | |
United States, Louisiana | |
Christus Schumpert Cancer Treatment Center | |
Shreveport, Louisiana, United States, 71101 | |
United States, Michigan | |
William Beaumont Hospital - Royal Oak Campus | |
Royal Oak, Michigan, United States, 48073 | |
United States, New Jersey | |
Jersey Shore Cancer Center at Jersey Shore University Medical Center | |
Neptune, New Jersey, United States, 07754-0397 |
Study Chair: | Jean A. Hurteau, MD | Evanston Northwestern Healthcare - Evanston Hospital |
Study ID Numbers: | CDR0000069441, GOG-0198 |
Study First Received: | July 8, 2002 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00041080 History of Changes |
Health Authority: | United States: Food and Drug Administration |
stage III ovarian epithelial cancer stage IV ovarian epithelial cancer recurrent ovarian epithelial cancer fallopian tube cancer peritoneal cavity cancer |
Fallopian Tube Cancer Immunologic Factors Thalidomide Gonadal Disorders Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Urogenital Neoplasms Ovarian Diseases Selective Estrogen Receptor Modulators Hormones Genital Diseases, Female Anti-Bacterial Agents Estrogen Receptor Modulators Peritoneal Diseases |
Ovarian Cancer Endocrine Gland Neoplasms Estrogen Antagonists Estrogens Ovarian Neoplasms Digestive System Neoplasms Antineoplastic Agents, Hormonal Citric Acid Genital Neoplasms, Female Endocrine System Diseases Abdominal Neoplasms Ovarian Epithelial Cancer Angiogenesis Inhibitors Immunosuppressive Agents Tamoxifen |
Anti-Infective Agents Immunologic Factors Thalidomide Gonadal Disorders Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Urogenital Neoplasms Ovarian Diseases Selective Estrogen Receptor Modulators Genital Diseases, Female Anti-Bacterial Agents Estrogen Receptor Modulators |
Neoplasms by Site Therapeutic Uses Peritoneal Diseases Growth Inhibitors Angiogenesis Modulating Agents Endocrine Gland Neoplasms Estrogen Antagonists Ovarian Neoplasms Digestive System Neoplasms Antineoplastic Agents, Hormonal Growth Substances Genital Neoplasms, Female Endocrine System Diseases Abdominal Neoplasms Angiogenesis Inhibitors |