Urologic NeoplasmsPhase 2NCT00034593
A Phase 2 Trial of ALIMTA (Pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
A Phase 2 study testing ALIMTA and gemcitabine in people with Urologic Neoplasms, run by Eli Lilly and Company at 9 sites in 3 countries.
Trial summary
Definition: Patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment OR have moved to a new site in the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Urologic Neoplasms
- What is being tested?
- ALIMTA and gemcitabine
- How many people
- Not given
- Where
- 9 sitesin 3 countries
- 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
- You must have been diagnosed with bladder cancer that has recurred or moved to a new part of the body.
- You must have at least one tumor that can be physically measured or scanned by x-ray.
- You may not have had previous chemotherapy (drug) treatment OR you have had surgery followed by one chemotherapy treatment at least 4 months ago.
Who cannot join
- You may not have used an experimental medicine or device within the past month.
- Cancer that has spread to your brain.
- If you are unwilling or unable to take folic acid or vitamin B12 supplements.
Trial locations and contacts
9 sites in 3 countries.
9 sites in 3 countries
France5 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."
Bordeaux
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.
Lille
"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."
Marseille
"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."
Montpellier
"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."
Paris
Finland3 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."
Helsinki
"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."
Pikonlinna
"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."
Turku
Germany1 site
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.
Homburg/Saar
About this study
Definition: Patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment OR have moved to a new site in the body.
- Conditions
- Urologic Neoplasms
- Being tested
- ALIMTA, gemcitabine
- Keywords
- Bladder cancer, metastatic, transitional cell carcinoma of the urothelium
- Medical subject headings
- Urologic Neoplasms, Urinary Bladder Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALIMTADrug
gemcitabineDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2002 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic 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
- NCT00034593
- Sponsor's protocol ID
- 4699
- Other IDs
- H3E-MC-JMEV
- Status last verified
- Jul 2006
- First submitted
- 30 Apr 2002
- Last updated
- 19 Jul 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Trial of ALIMTA (Pemetrexed) Plus Gemcitabine in Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelium
- ClinicalTrials.gov ID
- NCT00034593
- Acronym / sponsor ID
- 4699
- Conditions
- Urologic Neoplasms
- Keywords
- Bladder cancer, metastatic, transitional cell carcinoma of the urothelium
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- First posted
- 1 May 2002 (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.
Definition: Patients with bladder cancer will be participating in this study for the treatment of abnormal cells in the bladder that have returned after initial treatment OR have moved to a new site in the body.
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 (3 listed)
- You must have been diagnosed with bladder cancer that has recurred or moved to a new part of the body.
- You must have at least one tumor that can be physically measured or scanned by x-ray.
- You may not have had previous chemotherapy (drug) treatment OR you have had surgery followed by one chemotherapy treatment at least 4 months ago.
Key exclusion criteria (3 listed)
- You may not have used an experimental medicine or device within the past month.
- Cancer that has spread to your brain.
- If you are unwilling or unable to take folic acid or vitamin B12 supplements.
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 | – |
| gemcitabine | 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 19 Jul 2006.
Related trials for Urologic Neoplasms
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Recruiting
Rehabilitation and Sex Therapy to Optimize Recovery After Prostate Cancer Treatment
Prostate Cancer, Urinary Incontinence
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
9 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALIMTA and gemcitabine in people with Urologic Neoplasms, run by Eli Lilly and Company at 9 sites in 3 countries.
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 3 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 19 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 9 sites in France, Finland, Germany. 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 19 Jul 2006.