Bladder CancerPhase 2NCT00627432
Gemcitabine With Or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Bladder Cancer
A Phase 2 study testing gemcitabine hydrochloride and oxaliplatin in people with Bladder Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- gemcitabine hydrochloride and oxaliplatin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2004to Mar 2009
- 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 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Histologically confirmed urothelial carcinoma, or transitional cell carcinoma of the bladder or upper urinary tract
- Locally advanced disease (T4b) or metastatic disease (N2, N3, or M1)
- Unable to receive cisplatin-based chemotherapy due to creatinine clearance 30-60 mL/min or performance status 2
- At least 1 unidimensionally measurable lesion according to RECIST criteria
- No nonmeasurable lesions only, including any of the following:
- Ascites
- Pleural or pericardial effusion
- Bone metastases
- Lymphangitis
- No symptomatic cerebral metastases unless they have been stabilized
PATIENT CHARACTERISTICS:
- See Disease Characteristics
- Performance status 0-2
- ANC ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Alkaline phosphatase ≤ 2 times normal (unless bone metastases are present)
- Transaminases ≤ 2 times normal (5 times normal if hepatic metastases present)
- Bilirubin ≤ 1.5 times normal
- Not pregnant or nursing
- Fertile patients must use effective contraception during and for at least 6 months after completion of treatment
- No prior malignancy within the past 5 years except carcinoma in situ of the cervix or basal cell skin cancer
- No peripheral neuropathy ≥ grade 2
- No uncontrolled infection
- No other medical conditions that could interfere with evaluating tolerability, including any of the following:
- Congestive heart failure
- Angina pectoris that cannot be stabilized with medication
- Myocardial infarction within the past 12 months
- Serious thromboembolic disease
- No psychologic, social, or geographic reason that would make follow-up impossible
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior chemotherapy for advanced disease
- More than 4 weeks since prior radiotherapy to a target measurable lesion
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
About this study
Official title: Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with oxaliplatin works compared to gemcitabine alone in treating patients with locally advanced or metastatic bladder cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the objective response rate in patients with advanced urothelial cancer treated with gemcitabine hydrochloride with vs without oxaliplatin.
Secondary
- Determine the tolerance of these regimens in these patients.
- Determine the overall survival and progression-free survival of patients treated with these regimens.
- Determine the quality of life of patients treated with these regimens.
- Determine the duration of response in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15.
- Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16.
Treatment in both arms repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
- Conditions
- Bladder Cancer
- Being tested
- gemcitabine hydrochloride, oxaliplatin
- Keywords
- stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine, | Active comparator | •Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15. Receives: Drug: gemcitabine hydrochloride |
| Gemcitabine, Oxaliplatine | Experimental | •Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16. Receives: Drug: gemcitabine hydrochloride; Drug: oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate
Measured: From baseline to the end of treatment, up to 6 months
Secondary outcomes (5)
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE)
Measured: From baseline to the end of treatment, up to 6 months
Overall survival
Measured: From baseline to the end of treatment, up to 6 months
Progression-free survival
Measured: From baseline to the end of treatment, up to 6 months
Quality of life as assessed by QLQ-C30 and QLQ-LC13
Measured: From baseline to the end of treatment, up to 6 months
Duration of response
Measured: From baseline to the end of treatment, up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study startJul 2004
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Damien Pouessel, MD, Study chair, Institut du Cancer de Montpellier - Val d'Aurelle
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00627432
- Sponsor's protocol ID
- CDR0000574179
- Other IDs
- CLCC-VESUNFIT, RECF0368, SANOFI-AVENTIS-CLCC-VESUNFIT, LILLY-CLCC-VESUNFIT
- Status last verified
- Feb 2025
- First submitted
- 29 Feb 2008
- Last updated
- 18 Feb 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Randomized Study Evaluating the Efficacy of Gemcitabine With or Without Oxaliplatin in Patients With Advanced Urothelial Cancer That Cannot be Treated With Cisplatin-based Chemotherapy
- ClinicalTrials.gov ID
- NCT00627432
- Acronym / sponsor ID
- CDR0000574179
- Conditions
- Bladder Cancer
- Keywords
- stage III bladder cancer, stage IV bladder cancer, transitional cell carcinoma of the bladder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- Jul 2004
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 3 Mar 2008 (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.
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This randomized phase II trial is studying how well giving gemcitabine together with oxaliplatin works compared to gemcitabine alone in treating patients with locally advanced or metastatic bladder cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the objective response rate in patients with advanced urothelial cancer treated with gemcitabine hydrochloride with vs without oxaliplatin.
Secondary
- Determine the tolerance of these regimens in these patients.
- Determine the overall survival and progression-free survival of patients treated with these regimens.
- Determine the quality of life of patients treated with these regimens.
- Determine the duration of response in patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15.
- Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16.
Treatment in both arms repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine, | Active comparator | Drug: gemcitabine hydrochloride•Arm I: Patients receive gemcitabine hydrochloride IV over 120 minutes on days 1, 8, and 15. |
| Gemcitabine, Oxaliplatine | Experimental | Drug: gemcitabine hydrochloride, Drug: oxaliplatin•Arm II: Patients receive gemcitabine IV over 100 minutes on days 1 and 15 and oxaliplatin IV over 120 minutes on days 2 and 16. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 hydrochloride | Drug | Gemcitabine,, Gemcitabine, Oxaliplatine |
| oxaliplatin | Drug | Gemcitabine, Oxaliplatine |
Primary outcome
Objective response rate
Time frame: From baseline to the end of treatment, up to 6 months
5 secondary outcomes
Adverse events according to Common Terminology Criteria for Adverse Events (CTCAE)
Time frame: From baseline to the end of treatment, up to 6 months
Overall survival
Time frame: From baseline to the end of treatment, up to 6 months
Progression-free survival
Time frame: From baseline to the end of treatment, up to 6 months
Quality of life as assessed by QLQ-C30 and QLQ-LC13
Time frame: From baseline to the end of treatment, up to 6 months
Duration of response
Time frame: From baseline to the end of treatment, up to 6 months
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 18 Feb 2025.
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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.
Damien Pouessel, MD study chair
Institut du Cancer de Montpellier - Val d'Aurelle
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 hydrochloride and oxaliplatin in people with Bladder Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle 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?
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 18 Feb 2025. 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 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?
Objective response rate (time frame: From baseline to the end of treatment, up to 6 months). 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 18 Feb 2025.