Liver CancerPhase 2NCT00191412
A Study of Pemetrexed in the Treatment of Patients With Advanced Metastatic Cancer of the Liver
A Phase 2 study testing Pemetrexed in people with Liver Cancer, run by Eli Lilly and Company at 1 site in United States.
Trial summary
This study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Cancer
- What is being tested?
- Pemetrexed
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2005to Mar 2006
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of cancer of the liver which is metastatic or locally recurrent and not amendable to curative therapy.
- Patient must have measurable disease
- Patient may have received prior arterial chemoembolization, completed 8 weeks prior to study enrollment, but no other previous chemotherapy
- Prior radiation is permitted, but must be completed at least 2 weeks prior to study enrollment.
- Prior central nervous system metastases are acceptable if the patient has received radiation ot the brain, is not on steroids, and does not have related symptoms.
Who cannot join
- Patients who have had prior therapy with Pemetrexed.
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- Patients who have received radiation to more than 25% of marrow
Trial locations and contacts
1 site in 1 country.
United States1 site
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician
Denver, Colorado
About this study
Official title: Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma
This study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.
- Conditions
- Liver Cancer
- Being tested
- Pemetrexed
- Medical subject headings
- Liver Neoplasms
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.
Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors
Secondary outcomes (6)
Toxicity measured by CTCAE grading
Duration of response: First complete or partial response until progressive disease (PD) or death of any cause
Duration of stable disease: Enrollment to PD or death of any cause
Time to treatment failure: Enroll. to PD, death of any cause, early discontinuation of treatment for any reason other than adequate response or start of new therapy
Progression-free survival: Enroll. to PD or death of any cause
Overall survival: Enroll. to death of any cause
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 startJan 2005
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CancerStudies 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
- 41 participants
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT) - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00191412
- Sponsor's protocol ID
- 9417
- Other IDs
- H3E-US-S055
- Status last verified
- Nov 2007
- First submitted
- 12 Sep 2005
- Last updated
- 20 Nov 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Single-Agent Alimta in the Treatment of Patients With Advanced and Metastatic Hepatoma
- ClinicalTrials.gov ID
- NCT00191412
- Acronym / sponsor ID
- 9417
- Conditions
- Liver Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Study completion
- Mar 2006 (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 study is to assess the response rate, toxicity, time-to-event efficacy, and potential markers of pemetrexed in patients with liver cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of cancer of the liver which is metastatic or locally recurrent and not amendable to curative therapy.
- Patient must have measurable disease
- Patient may have received prior arterial chemoembolization, completed 8 weeks prior to study enrollment, but no other previous chemotherapy
- Prior radiation is permitted, but must be completed at least 2 weeks prior to study enrollment.
- Prior central nervous system metastases are acceptable if the patient has received radiation ot the brain, is not on steroids, and does not have related symptoms.
Key exclusion criteria (3 listed)
- Patients who have had prior therapy with Pemetrexed.
- Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
- Patients who have received radiation to more than 25% of marrow
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
Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors
6 secondary outcomes
Toxicity measured by CTCAE grading
Duration of response: First complete or partial response until progressive disease (PD) or death of any cause
Duration of stable disease: Enrollment to PD or death of any cause
Time to treatment failure: Enroll. to PD, death of any cause, early discontinuation of treatment for any reason other than adequate response or start of new therapy
Progression-free survival: Enroll. to PD or death of any cause
Overall survival: Enroll. to death of any cause
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 20 Nov 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.
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT) - 5 hours, EST) study director
Eli Lilly and Company
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 Liver Cancer, 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 5 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 20 Nov 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?
Antitumor activity as measured by Response Evaluation Criteria in Solid Tumors. 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 20 Nov 2007.