Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy
NCT ID: NCT00096187
Last Updated: 2018-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
55 participants
INTERVENTIONAL
2005-07-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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TREATMENT
NONE
Interventions
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pemetrexed disodium
Eligibility Criteria
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Inclusion Criteria
* 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
120 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
Gynecologic Oncology Group
NETWORK
Principal Investigators
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David S. Miller, MD
Role: STUDY_CHAIR
Simmons Cancer Center
Allan Covens, MD
Role:
Toronto Sunnybrook Regional Cancer Centre
Locations
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Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, United States
Providence Saint Joseph Medical Center - Burbank
Burbank, California, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States
CCOP - Carle Cancer Center
Urbana, Illinois, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
St. John's Regional Health Center
Springfield, Missouri, United States
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, United States
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, United States
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, United States
Duke Comprehensive Cancer Center
Durham, North Carolina, United States
Wilson Medical Center
Wilson, North Carolina, United States
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, United States
Case Comprehensive Cancer Center
Cleveland, Ohio, United States
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, United States
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, United States
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, United States
Lake/University Ireland Cancer Center
Mentor, Ohio, United States
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, United States
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, United States
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States
UMC Southwest Cancer and Research Center
Lubbock, Texas, United States
Countries
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Other Identifiers
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GOG-0217
Identifier Type: -
Identifier Source: secondary_id
GOG-UC0205
Identifier Type: -
Identifier Source: secondary_id
LILLY-H3E-US-JMGR
Identifier Type: -
Identifier Source: secondary_id
CDR0000390347
Identifier Type: -
Identifier Source: org_study_id
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