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Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer Clinical research trials and Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer. Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer clinical trial. Human subjects often get the best healthcare possible for their Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer  Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
For Condition: endometrial adenocarcinoma,endometrial adenosquamous cell carcinoma,recurrent endometrial cancer,endometrial adenoacanthoma,endometrial papillary carcinoma,endometrial clear cell carcinoma
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: 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.
Details: OBJECTIVES: I. Determine the antitumor cytostatic activity of thalidomide, in terms of 6-month progression-free survival, in patients with recurrent or persistent endometrial carcinoma. II. Determine the nature and degree of toxicity of this drug in these patients. III. Determine the partial and complete response rates in patients treated with this drug. IV. Determine the duration of progression-free and overall survival in patients treated with this drug. V. Determine the effect of this drug on initial performance status and histological grade in these patients. PROTOCOL 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed endometrial carcinoma; Recurrent or persistent (refractory to curative therapy or established treatment); No sarcomas - At least 1 unidimensionally measurable lesion; At least 20 mm by conventional techniques, including palpation, plain x-ray, CT scan, or MRI OR At least 10 mm by spiral CT scan - At least 1 target lesion outside the area of prior radiotherapy - Received 1 prior chemotherapy regimen for endometrial carcinoma; Initial treatment may include high-dose therapy, consolidation, or extended therapy; No more than 1 additional cytotoxic regimen for recurrent or persistent disease; No non-cytotoxic chemotherapy for recurrent or persistent disease - Ineligible for higher priority GOG protocols (any active GOG phase III protocol for the same patient population) - No documented brain metastases since diagnosis of cancer; Patients with stable CNS deficits allowed provided there are no brain metastases, as confirmed by CT scan or MRI --Prior/Concurrent Therapy-- - Biologic therapy: At least 3 weeks since prior biologic or immunologic agents directed at malignancy; No prior thalidomide - Chemotherapy: See Disease Characteristics; At least 3 weeks since prior chemotherapy directed at malignancy and recovered - Endocrine therapy: At least 1 week since prior hormonal therapy directed at malignancy; Concurrent hormone replacement therapy allowed - Radiotherapy: See Disease Characteristics; At least 3 weeks since prior radiotherapy directed at malignancy and recovered; No prior radiotherapy to more than 25% of marrow-bearing areas - Surgery: Recovered from prior surgery - Other: At least 3 weeks since any prior therapy directed at malignancy; No prior cancer therapy that would preclude study --Patient Characteristics-- - Age: Not specified - Performance status: GOG 0-2 if patient received 1 prior regimen; GOG 0-1 if patient received 2 prior regimens - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); SGOT no greater than 2.5 times ULN; Alkaline phosphatase no greater than 2.5 times ULN - Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance greater than 60 mL/min - Other: Not pregnant; Negative pregnancy test; Fertile patients must use 2 methods of effective contraception for 4 weeks before, during, and for 4 weeks after study; No active infection requiring antibiotics; No sensory or motor neuropathy greater than grade 1; No other invasive malignancy within the past 5 years except non-melanoma skin cancer; No documented seizure disorders since diagnosis of cancer; Patients with a history of seizure disorders allowed provided that the seizures have been stable (i.e., no seizure within the past 12 months) while on an appropriately monitored treatment regimen
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ScottMcMeekin, Study Chair, Gynecologic Oncology Group
Tacoma General Hospital
Tacoma, Washington, 98405
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Australia New Zealand Gynaecological Oncology Trials Group
Camperdown, New South Wales, 1450
Australia
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73190
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0502
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
University of Birmingham
Birmingham, England, B15 2TT
United Kingdom
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Yale Comprehensive Cancer Center
New Haven, Connecticut, 06520-8028
United States
Additional Information:
Study ID Numbers: CDR0000068964; GOG-0229-B
Study Start Date: September 2001
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00025467
Other Endometrial Papillary Carcinoma Studies:
1. Comparison of Two Combination Chemotherapy Regimens Plus Radiation Therapy in Treating Patients With Stage III or Stage IV Endometrial Cancer
2. Radiation Therapy or No Further Treatment Following Surgery in Treating Patients With Stage I Endometrial Cancer
3. Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
4. Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
Related Studies:
Other endometrial papillary carcinoma Clinical Trials
Other Pennsylvania Clinical Trials
Other Abington Clinical Trials
Thalidomide in Treating Patients With Recurrent or Persistent Endometrial Cancer
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