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Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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):
GOG Foundation ( Gynecologic Oncology Group )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Good Prognosis Metastatic Gestational Trophoblastic Tumor Hydatidiform Mole Non-Metastatic Gestational Trophoblastic Tumor Uterine Corpus Choriocarcinoma Biological: Dactinomycin Drug: Methotrexate Phase 3

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Phase III Trial of Weekly Parenteral Methotrexate Versus "Pulsed" Dactinomycin as Primary Management for Low Risk Gestational Trophoblastic Neoplasia
Study Start Date : June 1999
Actual Primary Completion Date : July 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 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 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.
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003702


Locations
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United States, Pennsylvania
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Sponsors and Collaborators
Gynecologic Oncology Group
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Raymond Osborne Gynecologic Oncology Group
More Information
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Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00003702    
Other Study ID Numbers: 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 )
First Posted: January 27, 2003    Key Record Dates
Results First Posted: May 15, 2018
Last Update Posted: May 15, 2018
Last Verified: February 2016
Additional relevant MeSH terms:
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Choriocarcinoma
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Hydatidiform Mole
Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Dactinomycin
 Cactinomycin
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors