Bladder CancerPhase 2NCT01711112
Salvage Docetaxel for Pretreated Urothelial Cancer
A Phase 2 study testing Docetaxel in people with Bladder Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Based on the previous clinical experience in other cancers, and considering the absence of current standard salvage regimens, the single agent docetaxel is selected as the regimen for this phase II study. Main toxicity of docetaxel is myelosuppression. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2010to Dec 2013
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- aged over 20 years or older
- histologically confirmed metastatic and/or unresectable urothelial carcinoma arising from bladder, ureter, or renal pelvis
- ECOG performance status of 0 or 1
- measurable disease, or evaluable lesion(s), as defined by RECIST
- clinical failure of the prior chemotherapy for advanced disease, including gemcitabine and platinum
- adequate major organ functions
- written informed consent
Who cannot join
- severe co-morbid illness and/or active infections
- prior treatment with taxanes (paclitaxel and docetaxel)
- any patients judged by the investigator to be unfit to participate in the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Salvage Docetaxel in Patients With Advanced Urothelial Cancer Failed to Prior Chemotherapy
Based on the previous clinical experience in other cancers, and considering the absence of current standard salvage regimens, the single agent docetaxel is selected as the regimen for this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe myelosuppression observed in other cancer trials warrants further study in urothelial cancer. The objective of the study is to evaluate the safety and activity of weekly docetaxel given as salvage therapy for advanced urothelial cancer.
Read the detailed description
Study scheme
Patients eligible for this study will be offered participation. Screening numbers are endowed to all subjects who sign the informed consent forms. These screening numbers are used as 'Subject Identification Code" along with subject initials. Subjects withdrawn from the study retain their screening number.
Patients will have study drug discontinued at the time of progression and will then remain on study for a 4-week safety follow-up. Those without progression may continue to receive docetaxel as long as this is considered to be in their interest by their physician. After progression, patients will remain on study for the purpose of collecting follow-up and survival information.
VII-3. Study treatment
The study drug doses should be calculated taking the body surface area into consideration. Docetaxel 30 mg/m2 will be administered on days 1 and 8 every 3 weeks. Docetaxel will be diluted in 250 ml 0.9% saline or 5% dextrose to produce a final solution with concentration of 0.3-0.74 mg/ml. It will be administered as an infusion over 60 min on each infusion day. Patients will be premedicated with iv dexamethasone 15 mg, antihistamines and a prophylactic antiemetic treatment prior to docetaxel infusion in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Patients experiencing adverse events attributed to irinotecan should have treatment delay as needed and/or may be interrupted or reduced depending on individual tolerability and according to the protocol.
Treatment will be continued until disease progression, unacceptable toxicities, or consent withdrawal. After failure of study treatment, further treatment can be administered at the discretion of investigators.
- Conditions
- Bladder Cancer
- Being tested
- Docetaxel
- 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.
DocetaxelDrug
Treatment will be continued until progression, unacceptable toxicity, or refusal
| Study group | Role | What they receive |
|---|---|---|
| docetaxel | Experimental | Days 1 \& 8 Docetaxel 35 mg/m2 IV Receives: Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: 6 weeks
Secondary outcomes (1)
progression-free survival
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2012 (estimated)
- Study startAug 2010
- Primary completionApr 2013
- Study completionDec 2013
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 Samsung Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soon Il Lee, MD, Principal investigator, Dankook University Hospital, Cheonan, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01711112
- Sponsor's protocol ID
- 2010-03-072
- Status last verified
- Oct 2012
- First submitted
- 26 Sep 2012
- Last updated
- 15 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Salvage Docetaxel in Patients With Advanced Urothelial Cancer Failed to Prior Chemotherapy
- ClinicalTrials.gov ID
- NCT01711112
- Acronym / sponsor ID
- 2010-03-072
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Aug 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 22 Oct 2012 (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.
Based on the previous clinical experience in other cancers, and considering the absence of current standard salvage regimens, the single agent docetaxel is selected as the regimen for this phase II study. Main toxicity of docetaxel is myelosuppression. The low rate of severe myelosuppression observed in other cancer trials warrants further study in urothelial cancer. The objective of the study is to evaluate the safety and activity of weekly docetaxel given as salvage therapy for advanced urothelial cancer.
Detailed description
Study scheme
Patients eligible for this study will be offered participation. Screening numbers are endowed to all subjects who sign the informed consent forms. These screening numbers are used as 'Subject Identification Code" along with subject initials. Subjects withdrawn from the study retain their screening number.
Patients will have study drug discontinued at the time of progression and will then remain on study for a 4-week safety follow-up. Those without progression may continue to receive docetaxel as long as this is considered to be in their interest by their physician. After progression, patients will remain on study for the purpose of collecting follow-up and survival information.
VII-3. Study treatment
The study drug doses should be calculated taking the body surface area into consideration. Docetaxel 30 mg/m2 will be administered on days 1 and 8 every 3 weeks. Docetaxel will be diluted in 250 ml 0.9% saline or 5% dextrose to produce a final solution with concentration of 0.3-0.74 mg/ml. It will be administered as an infusion over 60 min on each infusion day. Patients will be premedicated with iv dexamethasone 15 mg, antihistamines and a prophylactic antiemetic treatment prior to docetaxel infusion in order to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Patients experiencing adverse events attributed to irinotecan should have treatment delay as needed and/or may be interrupted or reduced depending on individual tolerability and according to the protocol.
Treatment will be continued until disease progression, unacceptable toxicities, or consent withdrawal. After failure of study treatment, further treatment can be administered at the discretion of investigators.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| docetaxel | Experimental | Drug: DocetaxelDays 1 \& 8 Docetaxel 35 mg/m2 IV |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- aged over 20 years or older
- histologically confirmed metastatic and/or unresectable urothelial carcinoma arising from bladder, ureter, or renal pelvis
- ECOG performance status of 0 or 1
- measurable disease, or evaluable lesion(s), as defined by RECIST
- clinical failure of the prior chemotherapy for advanced disease, including gemcitabine and platinum
Key exclusion criteria (3 listed)
- severe co-morbid illness and/or active infections
- prior treatment with taxanes (paclitaxel and docetaxel)
- any patients judged by the investigator to be unfit to participate in the study
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 |
|---|---|---|
| DocetaxelTreatment will be continued until progression, unacceptable toxicity, or refusal | Drug | docetaxel |
Primary outcome
response rate
Time frame: 6 weeks
1 secondary outcome
progression-free survival
Time frame: 6 weeks
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 15 May 2014.
Related trials for Bladder Cancer
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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.
Soon Il Lee, MD principal investigator
Dankook University Hospital, Cheonan, Korea
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 Docetaxel in people with Bladder Cancer, run by Samsung Medical Center at 1 site in South Korea.
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 7 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 15 May 2014. 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 South Korea. 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?
response rate (time frame: 6 weeks). 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 15 May 2014.