Gestational Trophoblastic TumorPhase 2NCT00096187
Pemetrexed Disodium in Treating Patients With Recurrent or Persistent Low-Risk Gestational Trophoblastic Tumor After a Molar Pregnancy
A Phase 2 study testing pemetrexed disodium in people with Gestational Trophoblastic Tumor, run by Gynecologic Oncology Group at 25 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 120 years, women only
- Conditions the study is for
- Gestational Trophoblastic Tumor
- What is being tested?
- pemetrexed disodium
- How many people
- 55 participants
- Where
- 25 sitesUnited States
- Study dates
- Jul 2005to 23 Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 120 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
25 sites in 1 country.
25 sites in 1 country
United States25 sites
Rosenfeld Cancer Center at Abington Memorial Hospital
Abington, Pennsylvania, 19001
Lurleen Wallace Comprehensive Cancer at University of Alabama-Birmingham
Birmingham, Alabama, 35294
Providence Saint Joseph Medical Center - Burbank
Burbank, California, 91505
Blumenthal Cancer Center at Carolinas Medical Center
Charlotte, North Carolina, 28232-2861
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, 60611-3013
Charles M. Barrett Cancer Center at University Hospital
Cincinnati, Ohio, 45267
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University
Columbus, Ohio, 43210-1240
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390
Duke Comprehensive Cancer Center
Durham, North Carolina, 27710
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, 52242
UMC Southwest Cancer and Research Center
Lubbock, Texas, 79415-3364
Hillcrest Cancer Center at Hillcrest Hospital
Mayfield Heights, Ohio, 44124
Lake/University Ireland Cancer Center
Mentor, Ohio, 44060
Oklahoma University Cancer Institute
Oklahoma City, Oklahoma, 73104
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
Orange, California, 92868
McGlinn Family Regional Cancer Center at Reading Hospital and Medical Center
Reading, Pennsylvania, 19612-6052
St. John's Regional Health Center
Springfield, Missouri, 65804
Hulston Cancer Center at Cox Medical Center South
Springfield, Missouri, 65807
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
Cancer Institute of New Jersey at Cooper - Voorhees
Voorhees Township, New Jersey, 08043
Wilson Medical Center
Wilson, North Carolina, 27893-3428
About this study
Official title: A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
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.
Read the detailed description
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.
- Conditions
- Gestational Trophoblastic Tumor
- Being tested
- pemetrexed disodium
- Keywords
- low risk metastatic gestational trophoblastic tumor, recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor
- Medical subject headings
- Gestational Trophoblastic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pemetrexed disodiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Activity
Toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2004 (estimated)
- Study startJul 2005
- Primary completion23 Jul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Trophoblastic TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- David S. Miller, MD, Study chair, Simmons Cancer CenterAllan Covens, MD, Toronto Sunnybrook Regional Cancer Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00096187
- Sponsor's protocol ID
- CDR0000390347
- Other IDs
- GOG-0217, GOG-UC0205, LILLY-H3E-US-JMGR
- Status last verified
- Apr 2018
- First submitted
- 9 Nov 2004
- Last updated
- 12 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Pemetrexed (ALIMTA®, LY231514, IND #40061) as Salvage Therapy for Failed Low Risk Gestational Trophoblastic Tumor
- ClinicalTrials.gov ID
- NCT00096187
- Acronym / sponsor ID
- CDR0000390347
- Conditions
- Gestational Trophoblastic Tumor
- Keywords
- low risk metastatic gestational trophoblastic tumor, recurrent gestational trophoblastic tumor, nonmetastatic gestational trophoblastic tumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2005
- Primary completion
- 23 Jul 2007 (actual)
- First posted
- 9 Nov 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pemetrexed disodium | Drug | – |
Primary outcome
Activity
Toxicity
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David S. Miller, MD study chair
Simmons Cancer Center
Allan Covens, MD
Toronto Sunnybrook Regional Cancer Centre
25 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing pemetrexed disodium in people with Gestational Trophoblastic Tumor, run by Gynecologic Oncology Group at 25 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activity. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.