|
Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer Clinical research trials and Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer. Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer  Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer
Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer
For Condition: stage 3 endometrial cancer,stage 4 endometrial cancer,recurrent endometrial cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Gynecologic Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Estrogen can stimulate the growth of tumor cells. Hormone therapy using tamoxifen and megestrol may fight endometrial cancer by blocking the absorption of estrogen. It is not yet known whether chemotherapy is more effective than hormone therapy in treating endometrial cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy with that of hormone therapy in treating patients who have recurrent, stage III, or stage IV endometrial cancer .
Details: OBJECTIVES: I. Compare the progression-free survival and response of patients with stage III or IV or recurrent endometrial cancer treated with doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs tamoxifen and megestrol. II. Compare the survival of patients treated with these regimens. III. Determine if progesterone receptor status provides information on whether patients are more likely to benefit from chemotherapy. IV. Compare the toxicity profiles of these treatment regimens in these patients. V. Compare the quality of life of patients treated with these regimens. PROTOCOL OUTLINE: This is a randomized, cross-over, multicenter study. Patients are stratified according to progesterone receptor status (negative vs positive). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive chemotherapy comprising doxorubicin IV over 15-30 minutes followed by cisplatin IV over 1 hour on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously beginning on day 3 and continuing for 10 days. Chemotherapy repeats every 21 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. At time of disease progression, patients cross-over to hormonal therapy as in arm II. Arm II: Patients receive hormonal therapy comprising oral megestrol twice daily on weeks 1-3 followed by oral tamoxifen twice daily on weeks 4-6. Hormonal therapy repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. At time of disease progression, if patients have not previously been enrolled on arm I, patients cross-over to receive chemotherapy as in arm I. Quality of life is assessed at baseline, 6 weeks, time of progression, and then after 6 weeks on cross-over therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: Approximately 630 patients will be accrued for this study within 42 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed primary stage III or IV or recurrent endometrial cancer - Poor curative potential with radiotherapy or surgery (alone or in combination) - Measurable disease; At least one lesion accurately measured in at least one dimension; At least 20 mm by conventional techniques, including palpation, x-ray, CT scan, or MRI OR At least 10 mm by spiral CT scan; Disease in a previously irradiated field as sole site of measurable disease allowed only if clear progression after completion of radiotherapy - Estrogen receptor(ER)/progesterone receptor (PR) status of primary tumor required; ER/PR status of measurable tumor optional --Prior/Concurrent Therapy-- - Biologic therapy: Prior biologic therapy allowed - Chemotherapy: No prior cytotoxic chemotherapy, including chemotherapy for radiosensitization - Endocrine therapy: No prior hormonal therapy for endometrial cancer - Radiotherapy: See Disease Characteristics; At least 4 weeks since prior radiotherapy involving the whole pelvis or more than 50% of the spine - Surgery: See Disease Characteristics - Other: Concurrent cardiac conduction-altering medications such as digitalis, beta blockers, or calcium channel blockers allowed at the investigator's discretion --Patient Characteristics-- - Age: Not specified - Performance status: GOG 0-2 - Life expectancy: Not specified - Hematopoietic: Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3 - Hepatic: Bilirubin normal; SGPT no greater than 3 times upper limit of normal - Renal: Creatinine no greater than 1.6 mg/dL - Cardiovascular: LVEF at least 50%; No third-degree or complete heart block, unless pacemaker is in place; Other conduction abnormalities or cardiac dysfunction allowed at the investigator's discretion; No history of deep venous thrombosis; No uncontrolled angina - Pulmonary: No history of pulmonary embolus - Other: No other malignancy within the past 5 years except nonmelanoma skin cancer; No concurrent medical illness that would preclude study; No serious uncontrolled infection; No serious peripheral neuropathy; No circumstances that would preclude study compliance; No sensitivity to E. coli-derived drug preparations
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyBloss, Study Chair, Gynecologic Oncology Group
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Lineberger Comprehensive Cancer Center, UNC
Chapel Hill, North Carolina, 27599-7295
United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, 90095-1781
United States
Tufts University School of Medicine
Boston, Massachusetts, 02111
United States
Washington University School of Medicine
St. Louis, Missouri, 63110
United States
University of Oklahoma College of Medicine
Oklahoma City, Oklahoma, 73190
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216-4505
United States
Schneider Children's Hospital at North Shore
Manhasset, New York, 11030
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, 35294-3300
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Cooper Hospital/University Medical Center
Camden, New Jersey, 08103
United States
Walter Reed Army Medical Center
Washington D.C., District of Columbia, 20307-5000
United States
State University of New York Health Sciences Center - Stony Brook
Stony Brook, New York, 11790-7775
United States
Cancer Center of Albany Medical Center
Albany, New York, 12208
United States
Comprehensive Cancer Center at Wake Forest University
Winston Salem, North Carolina, 27157-1082
United States
Medical University of South Carolina
Charleston, South Carolina, 29425-0721
United States
University of Colorado Cancer Center
Denver, Colorado, 80010
United States
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
United States
Simmons Cancer Center - Dallas
Dallas, Texas, 75235-9154
United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001
United States
Rush-Presbyterian-St. Luke's Medical Center
Chicago, Illinois, 60612
United States
Albert B. Chandler Medical Center, University of Kentucky
Lexington, Kentucky, 40536-0084
United States
Community Hospital of Los Gatos
Los Gatos, California, 95032
United States
Tacoma General Hospital
Tacoma, Washington, 98405
United States
University of Pennsylvania Cancer Center
Philadelphia, Pennsylvania, 19104-4283
United States
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
Ellis Fischel Cancer Center - Columbia
Columbia, Missouri, 65203
United States
Tom Baker Cancer Center - Calgary
Calgary, Alberta, T2N 4N2
Canada
Chao Family Comprehensive Cancer Center
Orange, California, 92868
United States
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
United States
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia
Philadelphia, Pennsylvania, 19107-5541
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, 45267-0502
United States
Cancer Center at the University of Virginia
Charlottesville, Virginia, 22908
United States
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850
United States
Brookview Research, Inc.
Nashville, Tennessee, 37203
United States
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, 52242-1009
United States
Fletcher Allen Health Care - Medical Center Campus
Burlington, Vermont, 05401
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263-0001
United States
Indiana University Cancer Center
Indianapolis, Indiana, 46202-5289
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
M.D. Anderson CCOP Research Base
Houston, Texas, 77030-4009
United States
State University of New York Health Science Center at Brooklyn
Brooklyn, New York, 11203
United States
Additional Information:
Study ID Numbers: CDR0000068624; GOG-0189
Study Start Date: May 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016341
Other Stage 4 Endometrial Cancer Studies:
1. Interleukin-12, Paclitaxel, and Trastuzumab in Treating Patients With Solid Tumors
2. Doxorubicin and Cisplatin With or Without Paclitaxel in Treating Patients With Locally Advanced, Metastatic, and/or Relapsed Endometrial Cancer
3. Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
4. Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
5. Paclitaxel in Treating Patients With Refractory or Recurrent Endometrial Cancer
Related Studies:
Other stage 4 endometrial cancer Clinical Trials
Other South Carolina Clinical Trials
Other Charleston Clinical Trials
Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer
|
|
|
|
|
|
|
|
