Bladder CancerPhase 2NCT00186277
Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
A Phase 2 study testing Oxaliplatin and Taxotere in people with Bladder Cancer, run by Stanford University at 1 site in United States.
Trial summary
To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Oxaliplatin and Taxotere
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2003to Dec 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
- Patient Population Type: Advanced Muscle Invasive Bladder Cancer
- Prior Therapy: One prior therapy for advanced disease
- Disease: Measurable disease
- ECOG Performance: 0,1
- Indication: Histologically Proven Carcinoma of the bladder
- For female patient of childbearing potential, neither pregnant nor breastfeeding, and under active contraception
- Allergies: No known allergy to one of the study drugs
- Patient Status:
- No CNS metastases
- No peripheral neuropathy > grade1
- No other serious concomitant illness
- Fully recovered from any prior therapy
- Informed Consent: Patient and doctor have signed informed consent
- Lower Age Limit: Lower age limit >18
- Upper Age Limit: Upper Age Limit <70
- ANC: ANC >1500/mm3 or WBC > 3000/mm3
- Platelets: Platelets >100,000/mm3
- Creatinine: Creatinine <1.8mg/dL
- Bilirubin: Bilirubin <=2.0 x ULN
- SGPT: SGPT (ALT) <=1.5 x ULN (<4xULN if liver metastases present)
- RBC: Hemoglobin > 9.0g/dL
- Cardiovascular: No active congestive heart failure, no uncontrolled angina, no myocardial infarction within the past 6 months
- Patients with metastatic cancer of the urothelial tract (TCC, Adenocarcinoma)
- No prior exposure to Oxaliplatin
- No cytotoxics or radiation 4 weeks prior to enrolling on protocol
- PT/PTT normal
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.
Read the detailed description
To test the combination of oxaliplatin chemotherapy in combination with taxotere chemotherapy in patients with advanced bladder cancer who have failed one prior chemotherapy.
- Conditions
- Bladder Cancer
- Being tested
- Oxaliplatin, Taxotere
- 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.
OxaliplatinDrug
Also called Eloxatin
Calculated per patient
TaxotereDrug
Also called Docetaxel
Calculated per patient
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability of the this combination in patients with recurrent metastatic bladder cancer.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startDec 2003
- Primary completionDec 2006
- Study completionDec 2006
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 Stanford UniversityThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Investigators
- Dr. Sandy Srinivas, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00186277
- Sponsor's protocol ID
- BLDR0001
- Other IDs
- BLDR0001
- Status last verified
- Mar 2011
- First submitted
- 13 Sep 2005
- Last updated
- 30 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Oxaliplatin and Taxotere in Metastatic Bladder Cancer
- ClinicalTrials.gov ID
- NCT00186277
- Acronym / sponsor ID
- BLDR0001
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- Sanofi-Synthelabo
- Study start
- Dec 2003
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 16 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.
To combine oxaliplatin and taxotere in patients who have had prior cisplatin therapy in bladder cancer.
Detailed description
To test the combination of oxaliplatin chemotherapy in combination with taxotere chemotherapy in patients with advanced bladder cancer who have failed one prior chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 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 |
|---|---|---|
| OxaliplatinAlso: EloxatinCalculated per patient | Drug | – |
| TaxotereAlso: DocetaxelCalculated per patient | Drug | – |
Primary outcome
Tolerability of the this combination in patients with recurrent metastatic bladder cancer.
Time frame: 1 year
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 30 Mar 2011.
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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.
Dr. Sandy Srinivas principal investigator
Stanford University
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 Oxaliplatin and Taxotere in people with Bladder Cancer, run by Stanford University 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?
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 30 Mar 2011. 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?
Tolerability of the this combination in patients with recurrent metastatic bladder cancer. (time frame: 1 year). 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 30 Mar 2011; AzTrials last refreshed its copy on 8 Nov 2026.