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| Sponsor: | Gynecologic Oncology Group |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00025467 |
Purpose
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have recurrent or persistent endometrial cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Cancer |
Drug: thalidomide |
Phase II |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent of Persistent Endometrial Carcinoma |
| Study Start Date: | September 2001 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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: Approximately 22-60 patients will be accrued for this study within 26 months.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed endometrial carcinoma
At least 1 unidimensionally measurable lesion
Received 1 prior chemotherapy regimen for endometrial carcinoma
No documented brain metastases since diagnosis of cancer
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
No documented seizure disorders since diagnosis of cancer
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations
Show 53 Study Locations| Study Chair: | D. Scott McMeekin, MD | Oklahoma University Cancer Institute |
More Information
| ClinicalTrials.gov Identifier: | NCT00025467 History of Changes |
| Other Study ID Numbers: | CDR0000068964, GOG-0229-B |
| Study First Received: | October 11, 2001 |
| Last Updated: | April 30, 2011 |
| Health Authority: | United States: Federal Government |
|
recurrent endometrial carcinoma endometrial adenocarcinoma endometrial adenosquamous cell carcinoma |
endometrial adenoacanthoma endometrial papillary serous carcinoma endometrial clear cell carcinoma |
|
Endometrial Neoplasms Sarcoma, Endometrial Stromal Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms Uterine Diseases Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors |
Thalidomide Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions Leprostatic Agents Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |