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Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

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ClinicalTrials.gov Identifier: NCT00003702
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : May 15, 2018
Last Update Posted : May 15, 2018
Sponsor:
Collaborators:
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group

November 1, 1999
January 27, 2003
November 2, 2017
May 15, 2018
May 15, 2018
June 1999
July 2010   (Final data collection date for primary outcome measure)
  • Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay [ Time Frame: Endpoint was assessed by hCG measurements taken weekly, once normal, treatment was bi-weekly, then monthly, up to 12 months. ]
    Primary outcome is measured as a difference in proportion responding between treatment arms and evaluated using a chi square test. A complete response was defined as a normal hCG sustained over four weekly measurements.
  • Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0 [ Time Frame: Prior to study entry, weekly during treatment, up to 12 months after normal titer, an average of 7 months. ]
    Number of participants with a maximum grade of 3 or higher during the treatment period.
Not Provided
Complete list of historical versions of study NCT00003702 on ClinicalTrials.gov Archive Site
Number of Patients With a Decline of hCG on Day 1 of Treatment [ Time Frame: Prior to study entry and on Day 1 of treatment ]
Number of patients with a decline in hCG on day 1 of treatment relative to the level at enrollment. A decline is defined as a decrease by 1 or more units between enrollment and treatment start.
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Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia
A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
Randomized phase III trial to compare the effectiveness of methotrexate with that of dactinomycin in treating patients who have gestational trophoblastic neoplasia. 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.

OBJECTIVES:

I. Compare the efficacy of methotrexate vs dactinomycin, as measured by complete response rate, in patients with low-risk gestational trophoblastic neoplasia.

II. Compare the toxicity of these regimens in these patients. III. 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.

Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Good Prognosis Metastatic Gestational Trophoblastic Tumor
  • Hydatidiform Mole
  • Non-Metastatic Gestational Trophoblastic Tumor
  • Uterine Corpus Choriocarcinoma
  • Biological: Dactinomycin
    Given IV
    Other Names:
    • Actinomycin A IV
    • Actinomycin C1
    • ACTINOMYCIN D
    • Actinomycin I1
    • Actinomycin IV
    • Actinomycin X 1
    • Actinomycin-[thr-val-pro-sar-meval]
    • Cosmegen
    • DACT
    • Dactinomycine
    • Lyovac Cosmegen
    • Meractinomycin
  • Drug: Methotrexate
    Given intramuscularly
    Other Names:
    • Abitrexate
    • Alpha-Methopterin
    • Amethopterin
    • Brimexate
    • CL 14377
    • CL-14377
    • Emtexate
    • Emthexat
    • Emthexate
    • Farmitrexat
    • Fauldexato
    • Folex
    • Folex PFS
    • Lantarel
    • Ledertrexate
    • Lumexon
    • Maxtrex
    • Medsatrexate
    • Metex
    • Methoblastin
    • Methotrexate LPF
    • Methotrexate Methylaminopterin
    • Methotrexatum
    • Metotrexato
    • Metrotex
    • Mexate
    • Mexate-AQ
    • MTX
    • Novatrex
    • Rheumatrex
    • Texate
    • Tremetex
    • Trexeron
    • Trixilem
    • WR-19039
  • Experimental: Arm I (methotrexate)
    Patients receive methotrexate intramuscularly once weekly 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.
    Intervention: Drug: Methotrexate
  • Experimental: Arm II (dactinomycin)
    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.
    Intervention: Biological: Dactinomycin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
240
Not Provided
Not Provided
July 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
  • Performance status - GOG 0-2
  • WBC at least 3,000/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • 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
  • Creatinine no greater than 2.0 mg/dL
  • No significant prior abnormal renal function
  • 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
  • No prior chemotherapy for gestational trophoblastic neoplasia
  • No concurrent curettage except as needed to control vaginal bleeding or to rule out placental site pseudotumor
Sexes Eligible for Study: Female
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
Canada,   Japan,   South Africa
 
NCT00003702
GOG-0174
NCI-2011-02026 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
ECOG-G174
CDR0000066809
GOG-0174 ( Other Identifier: Gynecologic Oncology Group )
GOG-0174 ( Other Identifier: CTEP )
U10CA027469 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
  • Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)
Principal Investigator: Raymond Osborne Gynecologic Oncology Group
Gynecologic Oncology Group
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP