Urinary Bladder NeoplasmsPhase 1/2NCT00818350
Activity Study of Sunitinib In Metastatic Pretreated Urothelial Cancer
A Phase 1/2 study testing SUNITINIB in people with Urinary Bladder Neoplasms, run by Campania Younger Oncologists Association.
Trial summary
Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity. Almost all responding patients relapse within the first year, with a median survival of 12 months. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Urinary Bladder Neoplasms
- What is being tested?
- SUNITINIB
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- Jan 2009to Jan 2011
- Phase
- Phase 1/2
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- cytological confirmation of UROTHELIAL carcinoma
- Failure of Cisplatin-gemcitabine regimen as first-line
- Presence of measurable metastases
- Performance status 0-1 ECOG
- Age of 18 years or older
- Written informed consent
- Adequate organ function ( based on tests of hematologic, hepatic, renal and cardiac function).
Who cannot join
- administration of a previous biological therapy ( sorafenib , bevacizumab or mTor Inhibitor)
- brain metastases
- significant cardiac events within the 6 months prior to study drug administration.
About this study
Official title: Phase II Study of Sunitinib in Metastatic and Pretreated Urothelial Cancer
Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity.
Almost all responding patients relapse within the first year, with a median survival of 12 months. Prognosis is very poor in patients who display progressive disease after receiving combination cisplatin-based chemotherapy.
Read more
No standard has yet been established for second-line treatment and well designed trials of second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be given high priority.
Several drugs have been used in second line for metastatic disease with poor results.
The investigators have planned a Phase II study, open-label, single arm design to evaluate the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with standard regimen (cisplatin-gemcitabine).
No previous studies have been published with sunitinib in metastatic bladder cancer.
Read the detailed description
OBJECTIVES
- PRIMARY To determine the antitumor efficacy ( response rate) of sunitinib
- SECONDARY To determine: safety, duration of response, Quality of life (QoL), progression free survival (PFS) and overall survival (OS).
PLAN OF TREATMENT Patients received sunitinib at a starting dose of 50 mg per day in repeated 6-week cycles for 4 consecutive weeks followed by 2 weeks off treatment.
Sunitinib was self-administered orally once daily without regard to meals. Dose reduction for toxicity was allowed to 37.5 until 25 mg/day depending on the type and severity of toxicity encountered.
Sunitinib treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent.
EVALUATION
Baseline evaluations included:
- medical history
- physical examination;
- tumor assessment (total body TC and bone scan )
- assessment of ECOG PS
- QoL assessment
- Assessment of left ventricular ejection fraction by echocardiography
- ECG
- Laboratory measurements. Assessment of efficacy and safety
- Evaluation according RECIST criteria every 2 cycles (12 weeks) with TC
- Safety according NCI version 3 every cycle
- QoL every cycle EORTC-QOL-C30.• RESOURCE UTILIZATION ASSESSMENTS
EORTC QLQ-C30 questionnaire, developed by the EORTC for the measurement of quality of life in cancer patients in clinical trials.
For the analysis, the raw scores of the questionnaire are transformed into a 100-point scale. For the functional scales, the computed scores range from 0 to 100, with the higher scores representing a higher level of functioning. For the item scales relative to physical symptoms and financial impact, higher scores represent a higher level of symptoms or problems .
STATISTICAL METHODS
Benefit anticipated (%): >30% of response rate. Test size: 5%. Power 80%. Sample size: 25 patients.
- Conditions
- Urinary Bladder Neoplasms
- Being tested
- SUNITINIB
- 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.
SUNITINIBDrug
Also called SUTENT
50 MG ORAL, DAYS 1-28 FOLLOWED BY 2 WEEKS RESTING
| Study group | Role | What they receive |
|---|---|---|
| SUNITINIB | Experimental | Not described Receives: Drug: SUNITINIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the antitumor efficacy ( response rate) of sunitinib
Measured: 12 weeks
Secondary outcomes (2)
QOL
Measured: 6 WEEKS
TOXICITY ACCORDING NCI VERSION 3 CRITERIA
Measured: EVERY WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionAug 2009 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Bladder NeoplasmsStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campania Younger Oncologists Association
- Sponsor type
- University, hospital or other
- Investigators
- DI LORENZO GIUSEPPE, PHD, Principal investigator, Campania Younger Oncologists Association
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818350
- Sponsor's protocol ID
- AGOC O1
- Status last verified
- Jan 2009
- First submitted
- 5 Jan 2009
- Last updated
- 7 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sunitinib in Metastatic and Pretreated Urothelial Cancer
- ClinicalTrials.gov ID
- NCT00818350
- Acronym / sponsor ID
- AGOC O1
- Conditions
- Urinary Bladder Neoplasms
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Campania Younger Oncologists AssociationUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Aug 2009 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 7 Jan 2009 (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.
Gemcitabine and cisplatin represent the standard first-line chemotherapy in metastatic bladder carcinoma. This regimen has replaced in most centers the MVAC combination showing a similar efficacy but less toxicity.
Almost all responding patients relapse within the first year, with a median survival of 12 months. Prognosis is very poor in patients who display progressive disease after receiving combination cisplatin-based chemotherapy.
No standard has yet been established for second-line treatment and well designed trials of second-line chemotherapy for metastatic transitional carcinoma of the urothelium should be given high priority.
Several drugs have been used in second line for metastatic disease with poor results.
The investigators have planned a Phase II study, open-label, single arm design to evaluate the activity and safety of sunitinib in metastatic urothelial carcinoma, pretreated with standard regimen (cisplatin-gemcitabine).
No previous studies have been published with sunitinib in metastatic bladder cancer.
Detailed description
OBJECTIVES
- PRIMARY To determine the antitumor efficacy ( response rate) of sunitinib
- SECONDARY To determine: safety, duration of response, Quality of life (QoL), progression free survival (PFS) and overall survival (OS).
PLAN OF TREATMENT Patients received sunitinib at a starting dose of 50 mg per day in repeated 6-week cycles for 4 consecutive weeks followed by 2 weeks off treatment.
Sunitinib was self-administered orally once daily without regard to meals. Dose reduction for toxicity was allowed to 37.5 until 25 mg/day depending on the type and severity of toxicity encountered.
Sunitinib treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent.
EVALUATION
Baseline evaluations included:
- medical history
- physical examination;
- tumor assessment (total body TC and bone scan )
- assessment of ECOG PS
- QoL assessment
- Assessment of left ventricular ejection fraction by echocardiography
- ECG
- Laboratory measurements. Assessment of efficacy and safety
- Evaluation according RECIST criteria every 2 cycles (12 weeks) with TC
- Safety according NCI version 3 every cycle
- QoL every cycle EORTC-QOL-C30.• RESOURCE UTILIZATION ASSESSMENTS
EORTC QLQ-C30 questionnaire, developed by the EORTC for the measurement of quality of life in cancer patients in clinical trials.
For the analysis, the raw scores of the questionnaire are transformed into a 100-point scale. For the functional scales, the computed scores range from 0 to 100, with the higher scores representing a higher level of functioning. For the item scales relative to physical symptoms and financial impact, higher scores represent a higher level of symptoms or problems .
STATISTICAL METHODS
Benefit anticipated (%): >30% of response rate. Test size: 5%. Power 80%. Sample size: 25 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SUNITINIB | Experimental | Drug: SUNITINIB |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- cytological confirmation of UROTHELIAL carcinoma
- Failure of Cisplatin-gemcitabine regimen as first-line
- Presence of measurable metastases
- Performance status 0-1 ECOG
- Age of 18 years or older
Key exclusion criteria (3 listed)
- administration of a previous biological therapy ( sorafenib , bevacizumab or mTor Inhibitor)
- brain metastases
- significant cardiac events within the 6 months prior to study drug administration.
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 |
|---|---|---|
| SUNITINIBAlso: SUTENT50 MG ORAL, DAYS 1-28 FOLLOWED BY 2 WEEKS RESTING | Drug | SUNITINIB |
Primary outcome
To determine the antitumor efficacy ( response rate) of sunitinib
Time frame: 12 weeks
2 secondary outcomes
QOL
Time frame: 6 WEEKS
TOXICITY ACCORDING NCI VERSION 3 CRITERIA
Time frame: EVERY WEEK
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2009.
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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.
DI LORENZO GIUSEPPE, PHD principal investigator
Campania Younger Oncologists Association
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SUNITINIB in people with Urinary Bladder Neoplasms, run by Campania Younger Oncologists Association.
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: status not confirmed, as of the sponsor's last update on 7 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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?
To determine the antitumor efficacy ( response rate) of sunitinib (time frame: 12 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 7 Jan 2009.