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Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Clinical research trials and Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer healthcare trials take place in a lot of of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer. Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "T" Clinical Trials Conditions > Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer  Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
For Condition: recurrent endometrial cancer,stage 3 endometrial cancer,endometrial adenocarcinoma,stage 4 endometrial cancer
Status: Suspended
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
Details: OBJECTIVES: - Determine the antitumor activity of trastuzumab (Herceptin) in patients with recurrent or advanced endometrial adenocarcinoma that overexpresses HER2 antigen. - Determine the toxicity of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive trastuzumab (Herceptin) IV over 30-90 minutes. Treatment continues weekly in the absence of disease progression or unacceptable toxicity. Patients are followed every two months. PROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed stage III, IV, or recurrent endometrial adenocarcinoma not amenable to radiotherapy or surgery alone or in combination - HER2 overexpression (2+ to 3+) - Measurable disease - Previously irradiated field as sole site of measurable disease allowed if evidence of progression since completion of radiotherapy - Not eligible for higher priority study (GOG-177 or its replacement) PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - GOG 0-2 Life expectancy: - At least 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - SGOT no greater than 3 times normal Renal: - Creatinine no greater than 2.0 mg/dL Cardiovascular: - LVEF at least 45% by ECHO or MUGA - History of coronary artery disease and/or congestive heart failure allowed if medical management of condition has been stable within the past 6 months - No active or unstable cardiac disease - No active angina - No myocardial infarction within the past 6 months Pulmonary: - No requirement for supplemental oxygen Other: - Not pregnant or nursing - No prior malignancy whose treatment would preclude study - No other prior or concurrent invasive malignancy within the past 5 years except non-melanoma skin cancer - No concurrent uncontrolled infection - No other unstable medical condition that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 3 weeks since prior biologic therapy for the malignant tumor - No prior anti-HER2 monoclonal antibody preparation - No other concurrent immunotherapy Chemotherapy: - Multiple prior chemotherapy regimens allowed - At least 3 weeks since prior chemotherapy for the malignant tumor and recovered - No more than 320 mg/m2 total dose of prior doxorubicin allowed (including doxorubicin HCl liposome or other liposomally encapsulated doxorubicin preparations) - No concurrent chemotherapy Endocrine therapy: - Prior hormonal therapy for the malignant tumor allowed - No concurrent hormonal therapy Radiotherapy: - See Disease Characteristics - At least 3 weeks since prior radiotherapy for the malignant tumor and recovered - No concurrent radiotherapy Surgery: - Recovered from prior recent surgery
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GiniFleming, Study Chair, University of Chicago Cancer Research Center
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Tuft-New England Medical Center
Boston, Massachusetts, 02111
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103-1489
United States
Holden Comprehensive Cancer Center
Iowa City, Iowa, 52242-1009
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Norwegian Radium Hospital
Oslo, , N-0310
Norway
University of Massachusetts Memorial Medical Center - University Campus
Worcester, Massachusetts, 01605-2982
United States
University of Texas Medical Branch
Galveston, Texas, 77555-0587
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11794-8091
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, 20892-1182
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1065
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612-3864
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
Ireland Cancer Center
Cleveland, Ohio, 44106
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Keesler Medical Center - Keesler AFB
Keesler AFB, Mississippi, 39534-2576
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001-3788
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
Additional Information:
Study ID Numbers: CDR0000068091; GOG-0181-B
Study Start Date:
Record last reviewed: April 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006089
Other Stage 3 Endometrial Cancer Studies:
1. Combination Chemotherapy in Treating Patients With Previously Untreated, Newly Diagnosed Epithelial Tumors
2. Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
3. Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer
4. Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
5. Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Related Studies:
Other stage 3 endometrial cancer Clinical Trials
Other Colorado Clinical Trials
Other Denver Clinical Trials
Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
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