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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: | NCT00025506 |
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: This phase II trial is studying how well thalidomide works in treating patients with recurrent or persistent carcinosarcoma of the uterus.
Condition | Intervention | Phase |
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Sarcoma |
Drug: thalidomide |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Carcinosarcoma of the Uterus |
Estimated Enrollment: | 51 |
Study Start Date: | September 2001 |
Estimated Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Patients receive oral thalidomide once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 3 years.
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed uterine sarcoma
Carcinosarcoma (malignant mixed mullerian tumor)
At least 1 unidimensionally measurable target lesion
No documented brain metastases since diagnosis of cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No seizure disorders since diagnosis of cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Study Chair: | D. Scott McMeekin, MD | Oklahoma University Cancer Institute |
Study ID Numbers: | CDR0000068967, GOG-0230B |
Study First Received: | October 11, 2001 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00025506 |
Health Authority: | United States: Food and Drug Administration |
recurrent uterine sarcoma uterine carcinosarcoma |
Thalidomide Malignant mesenchymal tumor Genital Neoplasms, Female Uterine Diseases Urogenital Neoplasms Recurrence Soft tissue sarcomas |
Genital Diseases, Female Neoplasms, Connective and Soft Tissue Sarcoma Uterine Neoplasms Uterine sarcoma Carcinosarcoma |
Anti-Infective Agents Neoplasms by Histologic Type Immunologic Factors Antineoplastic Agents Growth Substances Physiological Effects of Drugs Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions |
Anti-Bacterial Agents Neoplasms Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Neoplasms, Complex and Mixed Leprostatic Agents |