Carcinoma, Transitional CellPhase 2NCT00127595
Oxaliplatin With Gemcitabine in Patients With Carcinoma of the Urothelial Tract
A Phase 2 study testing gemcitabine, oxaliplatin in people with Carcinoma, Transitional Cell, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
Trial summary
This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Transitional Cell
- What is being tested?
- gemcitabine, oxaliplatin
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2002to Apr 2005
- 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
- Transitional cell carcinoma
- Histologically-proven
- Locally advanced unresectable or metastatic
- With at least one measurable target
- Informed consent signed
Who cannot join
- Previous chemotherapy
- Previous radiotherapy
- Performance status >=2
- Peripheral neuropathy >=1
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract
This is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.
- Conditions
- Carcinoma, Transitional Cell
- Being tested
- gemcitabine, oxaliplatin
- Keywords
- carcinoma of the urothelial tract
- Medical subject headings
- Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine, oxaliplatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
Secondary outcomes (3)
overall survival
disease free survival
toxicity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2005 (estimated)
- Study startJan 2002
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Transitional CellStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe 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
- 28 participants
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Investigators
- Christine THEODORE, Dr, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00127595
- Sponsor's protocol ID
- GEMOX
- Status last verified
- Aug 2005
- First submitted
- 5 Aug 2005
- Last updated
- 24 Aug 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Monocentric Study of Oxaliplatin in Combination With Gemcitabine in Patients With Advanced/Metastatic Transitional Cell Carcinoma of the Urothelial Tract
- ClinicalTrials.gov ID
- NCT00127595
- Acronym / sponsor ID
- GEMOX
- Conditions
- Carcinoma, Transitional Cell
- Keywords
- carcinoma of the urothelial tract
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 28 participants
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- Jan 2002
- Study completion
- Apr 2005
- First posted
- 8 Aug 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 is a phase II monocentric study of oxaliplatin (Ox) in combination with gemcitabine (Gem; GEMOX) in patients (pts) with advanced/metastatic transitional cell carcinoma (TCC) of the urothelial tract.
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)
- Transitional cell carcinoma
- Histologically-proven
- Locally advanced unresectable or metastatic
- With at least one measurable target
- Informed consent signed
Key exclusion criteria (4 listed)
- Previous chemotherapy
- Previous radiotherapy
- Performance status >=2
- Peripheral neuropathy >=1
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 |
|---|---|---|
| gemcitabine, oxaliplatin | Drug | – |
Primary outcome
response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria)
3 secondary outcomes
overall survival
disease free survival
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 24 Aug 2005.
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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.
Christine THEODORE, Dr principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
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 gemcitabine, oxaliplatin in people with Carcinoma, Transitional Cell, run by Gustave Roussy, Cancer Campus, Grand Paris at 1 site in France.
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 4 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: stopped early, as of the sponsor's last update on 24 Aug 2005. 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 France. 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?
response rate (Response Evaluation Criteria in Solid Tumors [RECIST] criteria). 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 24 Aug 2005.