Trophoblastic NeoplasmsPhase 2NCT00190918
A Trial for Patients With Gestational Trophoblastic Disease
A Phase 2 study testing Pemetrexed in people with Trophoblastic Neoplasms and Uterine Neoplasms, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Trophoblastic Neoplasms, Uterine Neoplasms, Hydatidiform Mole
- What is being tested?
- Pemetrexed
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2006to 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT)
- WHO score 2-6 (re-evaluated at the time of relapse
- Histologically confirmed complete or partial moles on initial evacuation
- Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
- All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
- Folic Acid (350-1000 micrograms) must be given daily beginning approximately 5-7 days prior to first dose of pemetrexed and continuing daily until 3 weeks after the last dose of study therapy.
- Vitamin B12 (1000 micrograms) will be administered as an intramuscular injection approximately 1 to 2 weeks prior to first dose of pemetrexed and repeated approximately every 9 weeks until 3 weeks after the last dose of study therapy.
Who cannot join
- Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid).
- Patients with more than 8 metastatic lesions identified
- Patients with metastases to liver, spleen, brain, kidney or GI tract
Trial locations and contacts
1 site in 1 country.
United States1 site
Gynecologic Oncology Group 215-854-0770
Philadelphia, Pennsylvania
About this study
Official title: A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor
This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.
- Being tested
- Pemetrexed
- Medical subject headings
- Trophoblastic Neoplasms, Uterine Neoplasms, Hydatidiform Mole, Choriocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PemetrexedDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
Secondary outcomes (1)
To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJul 2006
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trophoblastic NeoplasmsStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- 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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group
- Investigators
- David Miller, MD, Study chair, Gynecologic Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00190918
- Sponsor's protocol ID
- 8366
- Other IDs
- H3E-US-JMGR
- Status last verified
- Aug 2007
- First submitted
- 12 Sep 2005
- Last updated
- 9 Aug 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial of Pemetrexed (Alimta) in the Treatment of Recurrent or Persistent Low Risk Gestational Trophoblastic Tumor
- ClinicalTrials.gov ID
- NCT00190918
- Acronym / sponsor ID
- 8366
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group
- Study start
- Jul 2006
- Study completion
- Jul 2007 (actual)
- First posted
- 19 Sep 2005 (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.
This phase II study is evaluating the activity of Pemetrexed in patients diagnosed with low risk Gestational Trophoblastic Tumor (GTT) that have failed prior treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Persistent or recurrent low risk Gestational Trophoblastic Tumor (GTT)
- WHO score 2-6 (re-evaluated at the time of relapse
- Histologically confirmed complete or partial moles on initial evacuation
- Patients with mild to moderate renal insufficiency should avoid taking NSAIDs with short elimination half-lives for a period of 2 days before, the day of, and 2 days following administration of pemetrexed.
- All patients taking NSAIDs with longer half-lives, should interrupt dosing for at least 5 days before, the day of, and 2 days following pemetrexed administration.
Key exclusion criteria (3 listed)
- Previous treatment that included chemotherapy other than actinomycin -D or methotrexate (+/- folinic acid).
- Patients with more than 8 metastatic lesions identified
- Patients with metastases to liver, spleen, brain, kidney or GI tract
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 | Drug | – |
Primary outcome
To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
1 secondary outcome
To determine the toxicity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2007.
- Lilly Clinical Trial RegistryLink provided by the sponsor.
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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 Miller, MD study chair
Gynecologic Oncology Group
1 site 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 in people with Trophoblastic Neoplasms and Uterine Neoplasms, run by Eli Lilly and Company at 1 site 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?
The sponsor lists 7 inclusion and 3 exclusion criteria. 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: finished, as of the sponsor's last update on 9 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the activity of Pemetrexed in failed low risk Gestational Trophoblastic Tumor (GTT) patients. 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 9 Aug 2007.