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A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor

Phase 2
Not Enrolling
Gestational Trophoblastic Tumor

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Trial Information

A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor


- 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

Inclusion Criteria


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

- 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

- 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

- 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

- 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

- No concurrent prophylactic thrombopoietic agents unless for recurrent grade 4


- 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

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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Safety Issue:


Principal Investigator

David S. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2005

Completion Date:

Related Keywords:

  • Gestational Trophoblastic Tumor
  • low risk metastatic gestational trophoblastic tumor
  • recurrent gestational trophoblastic tumor
  • nonmetastatic gestational trophoblastic tumor
  • Hydatidiform Mole
  • Trophoblastic Neoplasms
  • Gestational Trophoblastic Neoplasms



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