|
Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent 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 Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent 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 Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer. Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent 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 Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer clinical trial. Human subjects often get the best healthcare possible for their Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent 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.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer  Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
For Condition: recurrent endometrial cancer,stage 3 endometrial cancer,stage 4 endometrial cancer
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy such as doxorubicin, cisplatin, paclitaxel, and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which combination chemotherapyregimen is more effective in treating endometrial cancer. PURPOSE: Randomizedphase III trial to compare the effectiveness of two combination chemotherapy regimens in treating patients who have stage III, stage IV, or recurrent endometrial cancer.
Details: OBJECTIVES: - Compare the efficacy of doxorubicin, cisplatin, paclitaxel, and filgrastim (G-CSF) vs carboplatin and paclitaxel, in terms of survival, in patients with stage III or IV or recurrent endometrial cancer. - Determine whether estrogen/progesterone receptor status provides prognostic information in patients treated with these regimens. - Compare the toxicity profile of these regimens, specifically neurotoxicity and infection, in these patients. - Compare the quality of life of patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive doxorubicin IV over 15 minutes and cisplatin IV over 60-90 minutes on day 1; paclitaxel IV over 3 hours on day 2; and filgrastim (G-CSF) subcutaneously on days 3-12. - Arm II: Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 1. In both arms, treatment repeats every 21 days for 7 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline and at weeks 6, 15, and 26 of study therapy. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 900 patients (450 per treatment arm) will be accrued for this study within approximately 5 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed endometrial carcinoma - FIGO stage III or IV or recurrent disease - Must know estrogen and progesterone status of the primary tumor - Poor potential for curative treatment by radiotherapy and/or surgery - At least 1 unidimensionally measurable lesion - At least 20 mm by conventional techniques (e.g., palpation, plain x-ray, CT scan, or MRI) OR at least 10 mm by spiral CT scan - Disease in a previously irradiated field acceptable as the only site of measurable disease only if there has been clear progression since completion of radiotherapy PATIENT CHARACTERISTICS: Age - 18 and over Performance status - GOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin normal - ALT no greater than 3 times upper limit of normal Renal - Creatinine no greater than 1.6 mg/dL Cardiovascular - LVEF at least 50% - Cardiac conduction abnormalities or dysfunction allowed at the investigator's discretion - No third-degree or complete heart block without a pacemaker - No uncontrolled angina Other - Not pregnant or nursing - Fertile patients must use effective non-hormonal contraception during and for at least 2 months after study participation - No other malignancy within the past 5 years except nonmelanoma skin cancer - No serious uncontrolled infection - No serious peripheral neuropathy - No other concurrent medical illness that would preclude study therapy - No circumstances that would preclude study completion or follow-up - No sensitivity to Escherichia coli-derived drug preparations PRIOR CONCURRENT THERAPY: Biologic therapy - Prior biologic therapy allowed - No concurrent biologic therapy Chemotherapy - No prior cytotoxic chemotherapy (including radiotherapy sensitization) for this or any other malignancy Endocrine therapy - Prior hormonal therapy allowed - No concurrent hormonal therapy Radiotherapy - See Disease Characteristics - At least 4 weeks since prior radiotherapy to the whole pelvis or over 50% of the spine Surgery - Not specified Other - Concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium channel blockers) are allowed at the investigator's discretion
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JeffreyBloss, Study Chair, Washington University Medical Center
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1065
United States
Recruiting Brigitte Miller 336-716-6673
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Anthony Evans 715-389-3101
Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook, New York, 11790-7775
United States
Recruiting Michael Pearl 631-444-2774
University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Denver, Colorado, 80010
United States
Recruiting Francis Major 303-388-4876
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0587
United States
Recruiting Edward Hannigan 409-772-3368
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Joseph Kelley 412-641-5418
Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville, Tennessee, 37917
United States
Recruiting Kenneth Cofer 865-673-9250
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103-1489
United States
Recruiting David Warshal 856-342-2185
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104-4283
United States
Recruiting Mark Morgan 215-662-6043
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Stephanie King 215-762-2640
Siteman Cancer Center *Recruiting*
St. Louis, Missouri, 63110
United States
Recruiting David Mutch 314-362
H. Lee Moffitt Cancer Center and Research Institute *Recruiting*
Tampa, Florida, 33612-9497
United States
Recruiting James Fiorica 813-972-8478
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
Yale Comprehensive Cancer Center *Recruiting*
New Haven, Connecticut, 06520-8028
United States
Recruiting Peter Schwartz 203-785-4014
Radiation Oncology Branch *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Alan Epstein 301-496-5457
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient Recruitment 888-NCI-1937
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Gunnar Kristensen 47-22-934-000
University of Massachusetts Memorial Medical Center - University Campus *Recruiting*
Worcester, Massachusetts, 01605-2982
United States
Recruiting Susan Zweizig 508-334-1160
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44124
United States
Recruiting Peter Rose 216-444-1712
Kagoshima City Hospital *Recruiting*
Kagoshima City, , 892-8580
Japan
Recruiting Masayuki Hatae 81-99-224-2101
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1002
United States
Recruiting Joel Sorosky 319-356-2015
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting Michael Method 574-237-8010
Clinical Genetics Branch *Recruiting*
Rockville, Maryland, 20852-7231
United States
Recruiting Mark Greene 301-594-7642
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill *Recruiting*
Chapel Hill, North Carolina, 27599-7295
United States
Recruiting Wesley Fowler 919-966-1196
University of Oklahoma College of Medicine *Recruiting*
Oklahoma City, Oklahoma, 73190
United States
Recruiting Robert Mannel 405-271-8787
Cancer Center at the University of Virginia *Recruiting*
Charlottesville, Virginia, 22908
United States
Recruiting Willie Andersen 434-924-9333
Fred Hutchinson Cancer Research Center *Recruiting*
Seattle, Washington, 98109-1024
United States
Recruiting Benjamin Greer 206-685-2463
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Katherine Look 317-274-8987
University of Minnesota Cancer Center *Recruiting*
Minneapolis, Minnesota, 55455
United States
Recruiting Linda Carson 612-626-3347
Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati, Ohio, 45267-0526
United States
Recruiting Nader Husseinzadeh 513-558-8450
Walter Reed Army Medical Center *Recruiting*
Washington D.C., District of Columbia, 20307-5001
United States
Recruiting G. Rose 202-782-8515
State University of New York at Stony Brook School of Medicine *Recruiting*
Stony Brook, New York, 11794
United States
Recruiting Michael Pearl 631-444-2774
CCOP - Scott and White Hospital *Recruiting*
Temple, Texas, 76508
United States
Recruiting Lucas Wong 254-724-7048
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Jeffrey Fowler 614-293-8737
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Daniel Clarke-Pearson 919-684-3765
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Robert Burger 714-456-7971
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Columbia, Missouri, 65203
United States
Recruiting Sara Crowder 573-882-1057
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Mack Barnes 205-934-0930
University of Texas - MD Anderson Cancer Center *Recruiting*
Houston, Texas, 77030-4009
United States
Recruiting Charles Levenback 713-745-2563
Gynecologic Oncology Network *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Howard Homesley 615-804-2216
Keesler Medical Center - Keesler Air Force Base *Recruiting*
Keesler AFB, Mississippi, 39534-2576
United States
Recruiting John Bomalaski 228-377-6396
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62794-9640
United States
Recruiting L. Massad 217-545-8882
Rush-Presbyterian-St. Luke's Medical Center *Recruiting*
Chicago, Illinois, 60612-3824
United States
Recruiting Howard Strassner 312-942-6723
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting George Olt 717-531-8144
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Marta Crispens 615-322-2114
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting Karen Wendling 773-834-7424
Memorial Sloan-Kettering Cancer Center *Recruiting*
New York City, New York, 10021
United States
Recruiting Carol Brown 212-639-7659
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Kenneth Noller 617-636-2382
Australia New Zealand Gynaecological Oncology Trials Group *Recruiting*
Camperdown, New South Wales, 1450
Australia
Recruiting Michael Friedlander 61-2-9562-1450
Fletcher Allen Health Care - Medical Center Campus *Recruiting*
Burlington, Vermont, 05401
United States
Recruiting Cheung Wong 802-847-5110
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Frederick Ueland 606-257-1613
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9032
United States
Recruiting David Miller 214-648-3026
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Steven Waggoner 216-844-5011
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-6188
United States
Recruiting Ellen Hartenbach 608-263-1209
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Nava Siegelmann-Danieli 570-271-6834
North Shore University Hospital *Recruiting*
Manhasset, New York, 11030
United States
Recruiting Andrew Menzin 516-562-4438
Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles, California, 90095-1740
United States
Recruiting Jonathan Berek 310-206-5161
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Tom Baker Cancer Center - Calgary *Recruiting*
Calgary, Alberta, T2N 4N2
Canada
Recruiting Gavin Stuart 403-944-1721
Tacoma General Hospital *Recruiting*
Tacoma, Washington, 98405
United States
Recruiting Roger Lee 253-403-1029
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111
United States
Recruiting Michael Bookman 215-728-2987
Women's Cancer Center at Community Hospital of Los Gatos *Recruiting*
Los Gatos, California, 95032
United States
Recruiting Nick Spirtos 408-866-3843
Abington Memorial Hospital *Recruiting*
Abington, Pennsylvania, 19001-3788
United States
Recruiting Parviz Hanjani 215-885-0220
Mayo Clinic Cancer Center *Recruiting*
Rochester, Minnesota, 55905-0001
United States
Recruiting Harry Long 507-284-4320
Additional Information:
Study ID Numbers: CDR0000305940; GOG-0209
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063999
Other Recurrent Endometrial Cancer Studies:
1. Combination Chemotherapy Compared With Hormone Therapy in Treating Patients With Recurrent, Stage III, or Stage IV Endometrial Cancer
2. Combination Chemotherapy in Treating Patients With Endometrial Cancer, Fallopian Tube Cancer, or Sarcoma of the Female Reproductive Tract
3. Trastuzumab in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
4. Erlotinib in Treating Patients With Locally Advanced and/or Metastatic Endometrial Cancer
5. Irofulven in Treating Patients With Persistent or Recurrent, Refractory Endometrial Cancer
Related Studies:
Other recurrent endometrial cancer Clinical Trials
Other Hawaii Clinical Trials
Other Honolulu Clinical Trials
Combination Chemotherapy in Treating Patients With Stage III, Stage IV, or Recurrent Endometrial Cancer
|
|
|
|
|
|
|
|
