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Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy

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. Identifier: NCT00096187
Recruitment Status : Terminated
First Posted : November 9, 2004
Last Update Posted : April 12, 2018
National Cancer Institute (NCI)
Information provided by:
GOG Foundation

Brief Summary:

RATIONALE: Drugs used in chemotherapy, such as pemetrexed disodium, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well pemetrexed disodium works in treating patients with recurrent or persistent low-risk gestational trophoblastic tumor after a molar pregnancy.

Condition or disease Intervention/treatment Phase
Gestational Trophoblastic Tumor Drug: pemetrexed disodium Phase 2

Detailed Description:


  • Determine the activity of pemetrexed disodium as salvage therapy in patients with persistent or recurrent low-risk post-molar gestational trophoblastic tumor that failed prior dactinomycin or methotrexate.
  • Determine the toxicity of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive pemetrexed disodium IV over 10 minutes on day 1. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression or until tumor marker levels (human chorionic gonadotropin [hCG]) become normal. Patients receive 2 additional courses beyond the attainment of a normal hCG.

Beginning 7 days before and continuing until 3 weeks after the last dose of pemetrexed disodium, patients also receive oral folic acid daily and cyanocobalamin (vitamin B_12) intramuscularly every 9 weeks.

Patients are followed every 2 weeks for 2 months and then monthly for 10 months.

PROJECTED ACCRUAL: Approximately 17-55 patients will be accrued for this study within 20-50 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
Study Start Date : July 2005
Actual Primary Completion Date : July 23, 2007

Primary Outcome Measures :
  1. Activity
  2. Toxicity

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No


  • Diagnosis of low-risk post-molar gestational trophoblastic tumor, defined as 1 of the following:

    • Increasing human chorionic gonadotropin (hCG) levels on ≥ 3 consecutive measurements taken over ≥ a 2-week period
    • Less than 10% decrease of hCG levels on 4 measurements taken over ≥ a 3-week period
  • Persistent or recurrent disease
  • Histologically confirmed complete or partial mole on initial evacuation

    • Prior pregnancy ≤ 12 months ago
  • No histologically confirmed choriocarcinoma or placental site trophoblastic tumor on initial evacuation
  • Failed only 1 prior dactinomycin or methotrexate therapy (with or without leucovorin calcium)
  • WHO score 2-6
  • No evidence of metastatic disease, except to the lung or vagina, on physical exam, chemistry, chest X-ray, and ultrasound

    • No liver, spleen, brain, kidney, or gastrointestinal tract metastases
    • No more than 8 metastatic lesions



  • Any age

Performance status

  • GOG 0-1

Life expectancy

  • Not specified


  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Granulocyte count ≥ 1,500/mm^3


  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • SGOT ≤ 3 times ULN
  • Alkaline phosphatase ≤ 3 times ULN


  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 45 mL/min


  • Not pregnant or nursing
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • No significant infection
  • No other invasive malignancy within the past 5 years except nonmelanoma skin cancer


Biologic therapy

  • No concurrent prophylactic filgrastim (G-CSF) unless for recurrent neutropenic complications
  • No concurrent prophylactic thrombopoietic agents unless for recurrent grade 4 thrombocytopenia


  • See Disease Characteristics
  • At least 7 days since prior dactinomycin or methotrexate (with or without leucovorin calcium) and recovered
  • No prior pemetrexed disodium
  • No other prior chemotherapy

Endocrine therapy

  • Not specified


  • At least 14 days since prior radiotherapy and recovered
  • No prior radiotherapy to ≥ 25% of the bone marrow


  • Recovered from prior surgery


  • No nonsteroidal anti-inflammatory drugs or salicylates for 2 days (or 5 days for drugs with a long half-life) before, during, and for 2 days after pemetrexed disodium administration

    • Concurrent low-dose aspirin (≤ 325 mg/day) allowed

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 identifier (NCT number): NCT00096187

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Sponsors and Collaborators
Gynecologic Oncology Group
National Cancer Institute (NCI)
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Study Chair: David S. Miller, MD Simmons Cancer Center
OverallOfficial: Allan Covens, MD Toronto Sunnybrook Regional Cancer Centre
Layout table for additonal information Identifier: NCT00096187    
Other Study ID Numbers: CDR0000390347
First Posted: November 9, 2004    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Keywords provided by GOG Foundation:
low risk metastatic gestational trophoblastic tumor
recurrent gestational trophoblastic tumor
nonmetastatic gestational trophoblastic tumor
Additional relevant MeSH terms:
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Trophoblastic Neoplasms
Gestational Trophoblastic Disease
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Pregnancy Complications, Neoplastic
Pregnancy Complications
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors