Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia - Full Text View

Sponsor:	Gynecologic Oncology Group
Collaborators:	National Cancer Institute (NCI) Eastern Cooperative Oncology Group
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003702

Purpose

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: Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia.

Condition	Intervention	Phase
Gestational Trophoblastic Tumor	Biological: dactinomycin Drug: methotrexate	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Randomized Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Manangement for Low Risk Gestational Trophoblastic Neoplasia

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Dactinomycin Methotrexate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Frequency of objective (complete) response as measured by normal beta human chorionic gonadotropin (HCG) levels [ Designated as safety issue: No ]
Frequency and severity of observed adverse effects [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Cure rate as measured by normal beta HCG levels [ Designated as safety issue: No ]

Estimated Enrollment:	216
Study Start Date:	June 1999
Estimated Primary Completion Date:	February 2003 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm I: Experimental Patients receive methotrexate intramuscularly once weekly in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta human chorionic gonadotropin (HCG) titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.	Drug: methotrexate Given intramuscularly
Arm II: Experimental Patients receive dactinomycin IV over 15 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients continue on treatment until 1 beta HCG titer is below the institutional normal. Patients then receive 1 additional consolidation treatment.	Biological: dactinomycin Given IV

Detailed Description:

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. Patients then receive 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

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003702

Hide Study Locations

Locations

United States, Alabama
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, United States, 35294
United States, California
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States, 92868
Todd Cancer Institute at Long Beach Memorial Medical Center
Long Beach, California, United States, 90801
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, United States, 90089-9181
United States, Connecticut
George Bray Cancer Center at the Hospital of Central Connecticut - New Britain Campus
New Britain, Connecticut, United States, 06050
United States, Florida
Lakeland Regional Cancer Center at Lakeland Regional Medical Center
Lakeland, Florida, United States, 33805
United States, Georgia
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
Savannah, Georgia, United States, 31403-3089
United States, Illinois
Evanston Northwestern Healthcare - Evanston Hospital
Evanston, Illinois, United States, 60201-1781
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611-3013
United States, Indiana
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
Howard Community Hospital
Kokomo, Indiana, United States, 46904
Indiana University Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202-5289
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Saint Joseph Regional Medical Center
South Bend, Indiana, United States, 46617
United States, Iowa
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States, 52242-1002
United States, Kentucky
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington, Kentucky, United States, 40536-0293
United States, Louisiana
Tulane Cancer Center Office of Clinical Research
Alexandria, Louisiana, United States, 71315-3198
United States, Massachusetts
Baystate Regional Cancer Program at D'Amour Center for Cancer Care
Springfield, Massachusetts, United States, 01199
Tufts-NEMC Cancer Center
Boston, Massachusetts, United States, 02111
United States, Michigan
Lakeland Regional Cancer Care Center - St. Joseph
St. Joseph, Michigan, United States, 49085
William Beaumont Hospital - Royal Oak Campus
Royal Oak, Michigan, United States, 48073
United States, Missouri
CCOP - Cancer Research for the Ozarks
Springfield, Missouri, United States, 65802
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States, 65807
Saint Louis University Cancer Center
Saint Louis, Missouri, United States, 63110
St. John's Regional Health Center
Springfield, Missouri, United States, 65804
United States, Nevada
Women's Cancer Center - Lake Mead
Las Vegas, Nevada, United States, 89102
United States, New Jersey
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees, New Jersey, United States, 08043
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
United States, New York
SUNY Downstate Medical Center
Brooklyn, New York, United States, 11203
United States, North Carolina
Duke Comprehensive Cancer Center
Durham, North Carolina, United States, 27710
Hope A Women's Cancer Center
Asheville, North Carolina, United States, 28801
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157-1096
United States, Ohio
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States, 43210-1240
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Cleveland Clinic Cancer Center at Fairview Hospital
Cleveland, Ohio, United States, 44111
Mount Carmel Health - West Hospital
Columbus, Ohio, United States, 43222
David L. Rike Cancer Center at Miami Valley Hospital
Dayton, Ohio, United States, 45409
Lake/University Ireland Cancer Center
Mentor, Ohio, United States, 44060
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States, 43214-3998
St. Rita's Medical Center
Lima, Ohio, United States, 45801
United States, Pennsylvania
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States, 19612-6052
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
United States, Texas
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Parkland Memorial Hospital
Dallas, Texas, United States, 75235
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
United States, Washington
Allenmore Hospital
Tacoma, Washington, United States, 98405
Auburn Regional Center for Cancer Care
Auburn, Washington, United States, 98002
CCOP - Northwest
Tacoma, Washington, United States, 98405
Good Samaritan Cancer Center
Puyallup, Washington, United States, 98372
St. Clare Hospital
Tacoma, Washington, United States, 98499
Providence Centralia Hospital
Centralia, Washington, United States, 98531-9027
Providence St. Peter Hospital Regional Cancer Center
Olympia, Washington, United States, 98506-5166
MultiCare Regional Cancer Center at Tacoma General Hospital
Tacoma, Washington, United States, 98405
St. Francis Hospital
Federal Way, Washington, United States, 98003
St. Joseph Medical Center at Franciscan Health System
Tacoma, Washington, United States, 98405-3004
Canada, Ontario
Edmond Odette Cancer Centre at Sunnybrook
Toronto, Ontario, Canada, M4N 3M5
Japan
Kagoshima City Hospital
Kagoshima City, Kagoshima, Japan, 892-8580
Tottori University Hospital
Tottori, Japan, 680-8550
Kobe Medical Center
Kobe, Japan, 654-0155
National Kyushu Cancer Center
Minami-ku, Japan, 811 1395
Keio University School of Medicine
Shinjuku-ku, Japan, 160-8582

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Eastern Cooperative Oncology Group

Investigators

Study Chair:	Raymond Osborne, MD, FRCSC, MBA	Edmond Odette Cancer Centre at Sunnybrook
Study Chair:	Higinia R. Cardenes, MD, PhD	Indiana University Melvin and Bren Simon Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000066809, GOG-174, ECOG-G174
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003702 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

hydatidiform mole
uterine choriocarcinoma
nonmetastatic gestational trophoblastic tumor
good prognosis metastatic gestational trophoblastic tumor

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Pregnancy Complications
Antimetabolites, Antineoplastic
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Antibiotics, Antineoplastic
Anti-Bacterial Agents
Dactinomycin
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Abortifacient Agents

Methotrexate
Trophoblastic Neoplasms
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors
Pregnancy Complications, Neoplastic
Neoplasms by Histologic Type
Hydatidiform Mole
Enzyme Inhibitors
Folic Acid Antagonists
Abortifacient Agents, Nonsteroidal
Immunosuppressive Agents
Pharmacologic Actions
Protein Synthesis Inhibitors
Neoplasms
Gestational Trophoblastic Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009