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Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment using a real mD. We aren't mDs. Always confer with your physician on Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia Clinical research trials and Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia healthcare trials happen in a lot of of localities across 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 generally measure the potency of new drugs. The aim of the studies / undertakings is to answer particular human medical questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, such as Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia. Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia Clinical Trials and other clinical trials allow volunteers to get healthcare treatment alternatives before they are available to the general public. Most times the participants receive treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia clinical trial. Human subjects often receive the most effective healthcare possible for their Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia condition. Risks are a reality, nonetheless, and may include more or frequent dr. calls, healthcare hazards (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with rigorous guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia  Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
For Condition: nonmetastatic gestational trophoblastic tumor,Hydatidiform Mole,uterine choriocarcinoma,good prognosis metastatic gestational trophoblastic tumor
Status: Recruiting
Sponsor(s): Gynecologic Oncology Group , National Cancer Institute (NCI),Eastern Cooperative Oncology Group
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether methotrexate is more effective than dactinomycin in treating patients with gestational trophoblastic neoplasia. PURPOSE: Randomizedphase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia.
Details: OBJECTIVES: - Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia. - Compare the toxicity of these regimens in these patients. - Determine whether the definition of persistent gestational trophoblastic neoplasia is accurate (as determined by the likelihood that the beta human chorionic gonadotropin [HCG] titer would decline on the day treatment is initiated). OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. All patients continue on treatment until 1 beta human chorionic gonadotropin (HCG) titer is below the institutional normal. Each patient then receives 1 additional consolidation treatment. Patients are followed every 4 weeks for 1 year. PROJECTED ACCRUAL: A total of 216 patients will be accrued for this study within 4 years.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically proven low-risk gestational trophoblastic neoplasia (persistent hydatidiform mole or choriocarcinoma), defined as 1 of the following: - Less than 10% decrease in the beta human chorionic gonadotropin (HCG) titer over 3 weekly titers - Greater than 20% sustained rise in beta HCG titer over two consecutive weeks - Persistently elevated beta HCG titer more than 4 months after initial curettage (greater than 5 mIU/mL minimum) - Histologically proven nonmetastatic choriocarcinoma - Metastases to vagina, parametria, or lung (if no single pulmonary lesion is greater than 2 cm) - WHO score 0-6 (not including blood group or CT lung) - No histologically confirmed placental site pseudotumor - Must have undergone at least 1 uterine curettage - Previously untreated disease PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - GOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 3,000/mm^3 - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - SGPT and SGOT no greater than 3 times ULN - Alkaline phosphatase no greater than 3 times ULN - No significant prior abnormal hepatic function Renal: - Creatinine no greater than 2.0 mg/dL - No significant prior abnormal renal function Other: - Not pregnant or nursing - Fertile patients must use effective contraception during and for one year after study entry - No other prior or concurrent malignancies within the past 5 years except nonmelanomatous skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy for gestational trophoblastic neoplasia Endocrine therapy: - Not specified Radiotherapy: - Not specified Surgery: - See Disease Characteristics - No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RaymondOsborne, Study Chair, Toronto Sunnybrook Regional Cancer Centre
Tacoma General Hospital *Recruiting*
Tacoma, Washington, 98405
United States
Recruiting Roger Lee 253-403-1029
Magee-Womens Hospital *Recruiting*
Pittsburgh, Pennsylvania, 15213-3180
United States
Recruiting Joseph Kelley 412-641-5418
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
NYU School of Medicine's Kaplan Comprehensive Cancer Center *Recruiting*
New York City, New York, 10016
United States
Recruiting Howard Hochster 212-652-1912
Arthur G. James Cancer Hospital - Ohio State University *Recruiting*
Columbus, Ohio, 43210-1240
United States
Recruiting Jeffrey Fowler 614-293-8737
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
Ellis Fischel Cancer Center at University of Missouri - Columbia *Recruiting*
Indianapolis, Indiana, 46285
United States
Recruiting Jeffrey Bloss 317-651-2677
Norwegian Radium Hospital *Recruiting*
Oslo, , N-0310
Norway
Recruiting Gunnar Kristensen 47-22-934-000
University of Oklahoma College of Medicine *Recruiting*
Oklahoma City, Oklahoma, 73190
United States
Recruiting Robert Mannel 405-271-8787
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
University of Chicago Cancer Research Center *Recruiting*
Chicago, Illinois, 60637-1470
United States
Recruiting S. Yamada 773-702-6722
University of Texas Medical Branch *Recruiting*
Galveston, Texas, 77555-0587
United States
Recruiting Edward Hannigan 409-772-3368
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
MBCCOP - Hawaii *Recruiting*
Honolulu, Hawaii, 96813
United States
Recruiting Brian Issell 808-586-3013
Indiana University Cancer Center *Recruiting*
Indianapolis, Indiana, 46202-5289
United States
Recruiting Katherine Look 317-274-8987
Abington Memorial Hospital *Recruiting*
Abington, Pennsylvania, 19001-3788
United States
Recruiting Parviz Hanjani 215-885-0220
CCOP - Grand Rapids *Recruiting*
Grand Rapids, Michigan, 49503
United States
Recruiting Kathleen Yost 616-391-1230
Fox Chase Cancer Center *Recruiting*
Philadelphia, Pennsylvania, 19111-2497
United States
Recruiting Lori Goldstein 215-728-2689
Comprehensive Cancer Center at Wake Forest University *Recruiting*
Winston Salem, North Carolina, 27157-1065
United States
Recruiting Brigitte Miller 336-716-6673
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
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
University of Alabama at Birmingham Comprehensive Cancer Center *Recruiting*
Birmingham, Alabama, 35294-3300
United States
Recruiting Carla Falkson 205-975-2691
CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield, Missouri, 65807
United States
Recruiting John Goodwin 417-269-4520
Gynecologic Oncology Network *Recruiting*
Nashville, Tennessee, 37203
United States
Recruiting Howard Homesley 615-804-2216
Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland, Ohio, 44124
United States
Recruiting Peter Rose 216-444-1712
CCOP - Central Illinois *Recruiting*
Decatur, Illinois, 62794-9640
United States
Recruiting L. Massad 217-545-8882
Duke Comprehensive Cancer Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Daniel Clarke-Pearson 919-684-3765
CCOP - Geisinger Clinic and Medical Center *Recruiting*
Danville, Pennsylvania, 17822-2001
United States
Recruiting Nava Siegelmann-Danieli 570-271-6834
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Kimmel Cancer Center at Thomas Jefferson University - Philadelphia *Recruiting*
Philadelphia, Pennsylvania, 19107-5541
United States
Recruiting Stephanie King 215-762-2640
Cooper University Hospital *Recruiting*
Camden, New Jersey, 08103-1489
United States
Recruiting David Warshal 856-342-2185
Holden Comprehensive Cancer Center at University of Iowa *Recruiting*
Iowa City, Iowa, 52242-1002
United States
Recruiting Joel Sorosky 319-356-2015
Long Island Cancer Center at Stony Brook University Hospital *Recruiting*
Stony Brook, New York, 11790-7775
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
MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque, New Mexico, 87131
United States
Recruiting Cynthia Cathcart 505-272-5688
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting Kenneth Noller 617-636-2382
University of Mississippi Medical Center *Recruiting*
Jackson, Mississippi, 39216-4505
United States
Recruiting James Thigpen 601-984-5590
CCOP - Evanston *Recruiting*
Evanston, Illinois, 60201
United States
Recruiting Gershon Locker 847-570-2518
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
Abramson Cancer Center at University of Pennsylvania Medical Center *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting Daniel Haller 215-662-6318
CCOP - Missouri Valley Cancer Consortium *Recruiting*
Omaha, Nebraska, 68106
United States
Recruiting James Mailliard 402-280-4364
Southeast Gynecologic Oncology Associates *Recruiting*
Knoxville, Tennessee, 37917
United States
Recruiting Kenneth Cofer 865-673-9250
Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington, Kentucky, 40536-0084
United States
Recruiting Frederick Ueland 606-257-1613
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Steven Waggoner 216-844-5011
Roswell Park Cancer Institute *Recruiting*
Buffalo, New York, 14263-0001
United States
Recruiting Shashikant Lele 716-845-5776
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting George Olt 717-531-8144
Saint Joseph Regional Medical Center *Recruiting*
South Bend, Indiana, 46617
United States
Recruiting Michael Method 574-237-8010
CCOP - Kansas City *Recruiting*
Kansas City, Missouri, 64131
United States
Recruiting Jorge Paradelo 816-823-0555
Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange, California, 92868
United States
Recruiting Robert Burger 714-456-7971
CCOP - Western Regional, Arizona *Recruiting*
Phoenix, Arizona, 85006-2726
United States
Recruiting David King 602-258-4875
CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor, Michigan, 48106
United States
Recruiting Philip Stella 734-712-2000
Women's Cancer Center at Community Hospital of Los Gatos *Recruiting*
Los Gatos, California, 95032
United States
Recruiting Nick Spirtos 408-866-3843
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 1-888-NCI-1937
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Anthony Evans 715-389-3101
CCOP - Columbia River Oncology Program *Recruiting*
Portland, Oregon, 97225
United States
Recruiting Keith Lanier 503-216-6260
CCOP - Christiana Care Health Services *Recruiting*
Newark, Delaware, 19713
United States
Recruiting Stephen Grubbs 302-623-4100
MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago, Illinois, 60612
United States
Recruiting Lawrence Feldman 312-335-3614
Simmons Cancer Center at University of Texas Southwestern Medical Center - Dallas *Recruiting*
Dallas, Texas, 75390-9032
United States
Recruiting David Miller 214-648-3026
University of Wisconsin Comprehensive Cancer Center *Recruiting*
Madison, Wisconsin, 53792-0001
United States
Recruiting James Stewart 608-265-8131
Toronto Sunnybrook Regional Cancer Centre *Recruiting*
Toronto, Ontario, M4N 3M5
Canada
Recruiting Raymond Osborne 416-480-4026
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center *Recruiting*
Nashville, Tennessee, 37232-2516
United States
Recruiting Marta Crispens 615-322-2114
Additional Information:
Study ID Numbers: CDR0000066809; GOG-174,ECOG-G174
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003702
Other Hydatidiform Mole Studies:
1. Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
Related Studies:
Other Hydatidiform Mole Clinical Trials
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Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
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