Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Tropho… (NCT00096187) | Clinical Trial Compass
TerminatedPhase 2
Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy
United States55 participantsStarted 2005-07
Plain-language 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.
Who can participate
Age range120 Years
SexFEMALE
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DISEASE CHARACTERISTICS:
* 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
PATIENT CHARACTERISTICS:
Age
* Any age
Performance status
* GOG 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count ≥ 1,500/mm\^3
* Platelet count ≥ 100,000/mm\^3
* Granulocyte count ≥ 1,500/mm\^3
Hepatic
* Bilirubin ≤ 1.5 times upper limit of normal (ULN)
* SGOT ≤ 3 times ULN
* Alkaline phosphatase ≤ 3 times ULN
Renal
* Creatinine ≤ 1.5 mg/dL
* Creatinine clearance ≥ 45 mL/min
Other
* Not pregnant or nursing
* Fertile patients must use effective contraception during and for 3 months after study participation
* No signifi…