Lung NeoplasmsPhase 2NCT00051506
ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.
A Phase 2 study testing ALIMTA, carboplatin and cisplatin in people with Lung Neoplasms, run by Eli Lilly and Company at 8 sites in United States.
Trial summary
The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Neoplasms
- What is being tested?
- ALIMTA, carboplatin and cisplatin
- How many people
- Not given
- Where
- 8 sitesUnited States
- Study dates
- Start not givento not given
- 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
- Have a diagnosis of extensive stage small cell lung cancer and can be treated with chemotherapy.
- Have received no prior chemotherapy for your disease.
- Have at least one measurable lesion.
- have an adequate performance status.
- Sign an informed consent form.
Who cannot join
- Have previously received chemotherapy for your lung cancer.
- Have been treated with a investigational drug within the last 30 days. Have previously completed or withdrawn from this study or any other study investigating ALIMTA.
- Have received radiation therapy within the last 1-2 weeks.
- Have brain metastasis that is uncontrolled.
- Have active infection or other serious condition.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Burlington, North Carolina
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Chapel Hill, North Carolina
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Charleston, South Carolina
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Fort Myers, Florida
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Latham, New York
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Los Angeles, California
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Miami, Florida
For additional information regarding investigative sites for this trial, contact the Clinical Trials Support Center at 1-877-CTLILLY(1-877-285-4559) or speak with your personal physician.
Springdale, Arkansas
About this study
The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer.
- Conditions
- Lung Neoplasms
- Being tested
- ALIMTA, carboplatin, cisplatin
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIMTADrug
carboplatinDrug
cisplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2003 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung 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
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00051506
- Sponsor's protocol ID
- 7210
- Other IDs
- H3E-US-JMFW
- Status last verified
- Jul 2006
- First submitted
- 10 Jan 2003
- Last updated
- 20 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALIMTA(Pemetrexed)/Cisplatin and ALIMTA(Pemetrexed)/Carboplatin in Extensive Stage Small Cell Lung Cancer.
- ClinicalTrials.gov ID
- NCT00051506
- Acronym / sponsor ID
- 7210
- Conditions
- Lung Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 14 Jan 2003 (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.
The purpose of this study is to evaluate the effects (good and bad) of ALIMTA plus Carboplatin or ALIMTA plus Cisplatin on you and your small cell lung cancer.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of extensive stage small cell lung cancer and can be treated with chemotherapy.
- Have received no prior chemotherapy for your disease.
- Have at least one measurable lesion.
- have an adequate performance status.
- Sign an informed consent form.
Key exclusion criteria (5 listed)
- Have previously received chemotherapy for your lung cancer.
- Have been treated with a investigational drug within the last 30 days. Have previously completed or withdrawn from this study or any other study investigating ALIMTA.
- Have received radiation therapy within the last 1-2 weeks.
- Have brain metastasis that is uncontrolled.
- Have active infection or other serious condition.
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 |
|---|---|---|
| ALIMTA | Drug | – |
| carboplatin | Drug | – |
| cisplatin | Drug | – |
Primary outcome
Not reported in the source record.
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 Jul 2006.
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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.
The record lists no contact. Use the official record to reach the sponsor.
8 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 ALIMTA, carboplatin and cisplatin in people with Lung Neoplasms, run by Eli Lilly and Company at 8 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?
The sponsor lists 5 inclusion and 5 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 Jul 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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.
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 Jul 2006.