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NCT00003702 · REGISTRY CONDITION SEARCH

Methotrexate Compared With Dactinomycin in Treating Patients With Gestational Trophoblastic Neoplasia

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE3
Status at capture
COMPLETED
Registry last update
2018-05-15

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Response Based on Blood Human Chorionic Gonadotropin (hCG) Assay

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outcome · POSTED

Incidence of Adverse Effects (Grade 3 or Higher) as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) Version 2.0

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outcome · POSTED

Number of Patients With a Decline of hCG on Day 1 of Treatment

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility 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
healthy Volunteers
false
sex
FEMALE
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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 Names
    1. Drug: Methotrexate
    label
    Arm I (methotrexate)
    type
    EXPERIMENTAL
  2. description
    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 Names
    1. Biological: Dactinomycin
    label
    Arm II (dactinomycin)
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Arm II (dactinomycin)
    description
    Given IV
    name
    Dactinomycin
    other Names
    1. Actinomycin A IV
    2. Actinomycin C1
    3. ACTINOMYCIN D
    4. Actinomycin I1
    5. Actinomycin IV
    6. Actinomycin X 1
    7. Actinomycin-[thr-val-pro-sar-meval]
    8. Cosmegen
    9. DACT
    10. Dactinomycine
    11. Lyovac Cosmegen
    12. Meractinomycin
    type
    BIOLOGICAL
  2. arm Group Labels
    1. Arm I (methotrexate)
    description
    Given intramuscularly
    name
    Methotrexate
    other Names
    1. Abitrexate
    2. Alpha-Methopterin
    3. Amethopterin
    4. Brimexate
    5. CL 14377
    6. CL-14377
    7. Emtexate
    8. Emthexat
    9. Emthexate
    10. Farmitrexat
    11. Fauldexato
    12. Folex
    type
    DRUG
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
240
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    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.
  2. description
    Number of participants with a maximum grade of 3 or higher during the treatment period.
    measure
    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.
secondary Outcomes
  1. description
    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.
    measure
    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
Full study description
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.
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.
Source references
Source notices and limitations
    Discovery and provenance
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      payload
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      true
      id
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      nct id
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      occurrences
      1. context exact
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        end
        11
        exact text
        NCT00003702
        start
        0
      offset unit
      unicode_code_points
      query cond
      Gestational Trophoblastic Disease
      query disease state id
      ds-gestational-trophoblastic-disease
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-gestational-trophoblastic-disease-000.json
      source file sha256
      1f1a29f1a432464f61f3af08097eaeb6242ebe2e1ee6ac5865a817223b28632a
      source json pointer
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      source kind
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      source record id
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      source string basis
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      source string sha256
      83a49c6f15c8241d2b834536caca12303613fa3df1b009b30ebba5572b8e6103

    Preserved source evidence · Not medical advice