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Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00003702
First Posted: January 27, 2003
Last Update Posted: February 10, 2016
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.
Collaborators:
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Gynecologic Oncology Group
  Purpose
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 Intervention Phase
Good Prognosis Metastatic Gestational Trophoblastic Tumor Hydatidiform Mole Non-Metastatic Gestational Trophoblastic Tumor Uterine Corpus Choriocarcinoma Biological: Dactinomycin Drug: Methotrexate Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Frequency and severity of observed adverse effects as assessed by the Gynecologic Oncology Group (GOG) toxicity criteria [ Time Frame: Up to 1 year ]
  • Frequency of objective (complete) response as measured by normal beta HCG levels [ Time Frame: Up to 1 year ]

Secondary Outcome Measures:
  • Cure rate as measured by normal beta HCG levels [ Time Frame: Up to a minimum of 1 year ]

Enrollment: 240
Study Start Date: June 1999
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
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
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
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
Principal Investigator: Raymond Osborne Gynecologic Oncology Group
  More Information

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT00003702     History of Changes
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 Submitted: November 1, 1999
First Posted: January 27, 2003
Last Update Posted: February 10, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Choriocarcinoma
Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Hydatidiform Mole
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Pregnancy Complications, Neoplastic
Pregnancy Complications
Methotrexate
Dactinomycin
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
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors
Anti-Bacterial Agents