Bladder CancerPhase 2NCT00393796
Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
A Phase 2 study testing SUTENT in people with Bladder Cancer, run by University of Michigan Rogel Cancer Center at 9 sites in United States.
Trial summary
This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- SUTENT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 9 sitesUnited States
- Study dates
- May 2006to Dec 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Histologic/cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma either pure or mixed histology)
- All patients must have received four - six cycles of standard first line chemotherapy (protocol details suggested combinations) for treatment of locally recurrent or metastatic disease AND must have achieved stable disease (SD), partial response (PR), or complete response (CR) to this chemotherapy.
- Type of response, number of cycles and specific regimen given must be carefully recorded and submitted at time of registration.
- Reports from pre and post treatment imaging will be required at time of registration to document response.
- Patients must be registered within 1 month (or the next business day if falls on a weekend or holiday) of scans demonstrating stable disease or better and no more than 42 days after receiving the last standard chemotherapy dose. For example, if patients are receiving treatment on days 1 and 8 of each cycle, day 8 of the last cycle would be considered the last standard chemotherapy dose.
- Patients may have received previous adjuvant or neoadjuvant therapy.
- No prior antiangiogenic therapy for this stage of the disease.
Who cannot join
- Major surgery within 4 weeks of starting the study treatment.
- NCI CTCAE grade 3 hemorrhage or higher within 4 weeks of starting the study treatment.
- History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
- Known HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.
- Any of the following within 6 months prior to study administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Patients with history of or who are suspected to have CHF can be included as long as they are asymptomatic and have an ejection fraction that is equal to or above the institutional lower limit of normal by baseline MUGA(obtained within one month of registration or the next business day if falls on a weekend or holiday).
Show all 12Show fewer
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade > 2.
- Unresolved bacterial infection.
- Uncontrolled hypertension.
- Pre-existing thyroid abnormality that can not be controlled medically.
- Concurrent treatment on another clinical trial.
- Pregnant or breast-feeding
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
The University of Chicago
Chicago, Illinois, 60637
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Weill Medical College of Cornell University
New York, New York, 10021
Columbia University Medical Center
New York, New York, 10032
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Mayo Clinic - Rochester
Rochester, Minnesota, 55905
About this study
Official title: Randomized Blinded Phase II Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer.
- Conditions
- Bladder Cancer
- Being tested
- SUTENT, Placebo
- 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.
SUTENTDrug
Also called SU011248
50 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| SUTENT | Active comparator | Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks. Receives: Drug: SUTENT |
| Placebo | Placebo comparator | Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks. Receives: Drug: SUTENT; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo
The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy.
Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Measured: 6 Months Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study startMay 2006
- Primary completionDec 2011
- Study completionDec 2012
Why it stopped: Low accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by University of Michigan Rogel Cancer 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
- Investigators
- Maha H. Hussain, M.D., Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393796
- Sponsor's protocol ID
- UMCC 2005.145
- Status last verified
- Nov 2014
- First submitted
- 27 Oct 2006
- Last updated
- 13 Nov 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Grivas PD, Daignault S, Tagawa ST, Nanus DM, Stadler WM, Dreicer R, Kohli M, Petrylak DP, Vaughn DJ, Bylow KA, Wong SG, Sottnik JL, Keller ET, Al-Hawary M, Smith DC, Hussain M. Double-blind, randomized, phase 2 trial of maintenance sunitinib versus placebo after response to chemotherapy in patients with advanced urothelial carcinoma. Cancer. 2014 Mar 1;120(5):692-701. doi: 10.1002/cncr.28477. Epub 2013 Nov 18.
PubMed 24249435
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Blinded Phase II Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
- ClinicalTrials.gov ID
- NCT00393796
- Acronym / sponsor ID
- UMCC 2005.145
- Conditions
- Bladder Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low accrual
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- May 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 30 Oct 2006 (estimated)
- Results
- Posted 13 Nov 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248 (SUTENT), for maintenance therapy in advanced urothelial cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SUTENT | Active comparator | Drug: SUTENTStudy participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks. |
| Placebo | Placebo comparator | Drug: SUTENT, Other: PlaceboStudy participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Histologic/cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma either pure or mixed histology)
- All patients must have received four - six cycles of standard first line chemotherapy (protocol details suggested combinations) for treatment of locally recurrent or metastatic disease AND must have achieved stable disease (SD), partial response (PR), or complete response (CR) to this chemotherapy.
- Type of response, number of cycles and specific regimen given must be carefully recorded and submitted at time of registration.
- Reports from pre and post treatment imaging will be required at time of registration to document response.
- Patients must be registered within 1 month (or the next business day if falls on a weekend or holiday) of scans demonstrating stable disease or better and no more than 42 days after receiving the last standard chemotherapy dose. For example, if patients are receiving treatment on days 1 and 8 of each cycle, day 8 of the last cycle would be considered the last standard chemotherapy dose.
Key exclusion criteria (12 listed)
- Major surgery within 4 weeks of starting the study treatment.
- NCI CTCAE grade 3 hemorrhage or higher within 4 weeks of starting the study treatment.
- History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
- Known HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.
- Any of the following within 6 months prior to study administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
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 |
|---|---|---|
| SUTENTAlso: SU01124850 mg/PO once daily for four consecutive weeks with a two week rest period. Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded. Participants receiving SU011248 will be removed from the study. Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248. | Drug | Placebo, SUTENT |
| Placebo | Other | Placebo |
Primary outcome
Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo
Time frame: 6 Months Post Treatment
The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy. Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24249435Grivas PD, Daignault S, Tagawa ST, Nanus DM, Stadler WM, Dreicer R, Kohli M, Petrylak DP, Vaughn DJ, Bylow KA, Wong SG, Sottnik JL, Keller ET, Al-Hawary M, Smith DC, Hussain M. Double-blind, randomized, phase 2 trial of maintenance sunitinib versus placebo after response to chemotherapy in patients with advanced urothelial carcinoma. Cancer. 2014 Mar 1;120(5):692-701. doi: 10.1002/cncr.28477. Epub 2013 Nov 18.
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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.
Maha H. Hussain, M.D. principal investigator
University of Michigan Rogel Cancer Center
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing SUTENT in people with Bladder Cancer, run by University of Michigan Rogel Cancer Center at 9 sites 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?
The sponsor lists 7 inclusion and 12 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 13 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 13 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo (time frame: 6 Months Post Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00393796, which also lists 1 linked publication.
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 13 Nov 2014.