Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy
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| ClinicalTrials.gov Identifier: NCT00096187 |
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Recruitment Status :
Terminated
First Posted : November 9, 2004
Last Update Posted : April 12, 2018
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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 |
OBJECTIVES:
- 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.
| 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 |
- Activity
- Toxicity
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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 |
DISEASE CHARACTERISTICS:
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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
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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
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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
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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
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 ClinicalTrials.gov identifier (NCT number): NCT00096187
Show 25 study locations
| Study Chair: | David S. Miller, MD | Simmons Cancer Center | |
| OverallOfficial: | Allan Covens, MD | Toronto Sunnybrook Regional Cancer Centre |
| ClinicalTrials.gov Identifier: | NCT00096187 |
| Other Study ID Numbers: |
CDR0000390347 GOG-0217 GOG-UC0205 LILLY-H3E-US-JMGR |
| First Posted: | November 9, 2004 Key Record Dates |
| Last Update Posted: | April 12, 2018 |
| Last Verified: | April 2018 |
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low risk metastatic gestational trophoblastic tumor recurrent gestational trophoblastic tumor nonmetastatic gestational trophoblastic tumor |
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Trophoblastic Neoplasms Gestational Trophoblastic Disease Neoplasms Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Pregnancy Complications, Neoplastic Pregnancy Complications |
Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |