Clinical trial · Interventional
Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy
A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
NCT00096187CI-TRIAL-00032490terminatedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gestational Trophoblastic Tumor | Gestational Trophoblastic Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pemetrexed disodium | Drug | Pemetrexed | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Activity
- measure
- Toxicity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 120 Years
Show eligibility criteria text
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 significant infection * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent prophylactic filgrastim (G-CSF) unless for recurrent neutropenic complications * No concurrent prophylactic thrombopoietic agents unless for recurrent grade 4 thrombocytopenia Chemotherapy * 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 Radiotherapy * At least 14 days since prior radiotherapy and recovered * No prior radiotherapy to ≥ 25% of the bone marrow Surgery * Recovered from prior surgery Other * 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
References
Publications (0)
Data not yet available
No reference posted for this study.