Recurrent Bladder CancerPhase 2NCT01118351

Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

A Phase 2 study testing sunitinib malate, immunohistochemistry staining method and TdT-mediated dUTP nick end labeling assay in people with Recurrent Bladder Cancer and Transitional Cell Carcinoma of the Bladder, run by Case Comprehensive Cancer Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with recurrent transitional cell bladder cancer. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Recurrent Bladder Cancer, Transitional Cell Carcinoma of the Bladder
What is being tested?: sunitinib malate, immunohistochemistry staining method and TdT-mediated dUTP nick end labeling assay
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 2 sitesUnited States
Study dates: Oct 2008to Sep 2015
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

Patients must have clinically and histologically proven, recurrent superficial transitional cell carcinoma of the bladder after treatment with BCG therapy
Patients could have received previous any INTRAVESICAL therapy including BCG and/or IFN and/or chemotherapy up to 3 years prior to registration
Patients biopsy specimen should be available for review
ECOG PS 0-1 (Karnofsky greater than 70%)
Absolute neutrophil count >= 1,000/mcL
Platelets >= 100,000/mcL

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Hemoglobin >= 8.5 g/dl
Total bilirubin =< 1.5 X institutional upper limit of normal
AST(SGOT)/ALT(SGPT) =< 3.5 X institutional upper limit of normal
Alkaline phosphatase =< 2.5 ULN ( =< 10 x ULN in presence of bone metastasis)
Serum calcium of =< 12 mg/dl
Creatinine =< 1.5 X institutional upper limit of normal
INR =< 1.5, except for subjects receiving warfarin therapy
Eligibility of patients receiving any medications or substances known to affect or with the potential to affect the activity or pharmacokinetics of Sunitinib (Sutent) will be determined following review of their case by the Principal Investigator
Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation; sexually active patients must continue to use contraception for three months after completion of study therapy; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately
All patients must be informed of the investigational nature of this study and must provide written informed consent in accordance with institutional and federal guidelines

Who cannot join

Prior systemic chemotherapy for bladder cancer; all other systemic chemotherapy must have been completed at least 3 years prior to enrollment
Prior treatment with any other anti-angiogenic therapy (including immunomodulatory agents such as thalidomide and lenalidomide, and anti-VEGF therapy with agents such as bevacizumab (Bevacizumab Avastin, Sunitinib (Sutent) and Sorafenib (Nexavar)
Prior major surgery (not TURBT/Cystoscopy), radiation therapy, or systemic therapy within 4 weeks of starting the study treatment
NCI CTCAE grade 3 hemorrhage within 4 weeks of starting study treatment
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism
Ongoing cardiac dysrhythmias of NCI CTCAE grade >= 2, or prolongation of the QTc interval to > 450 msec for males or > 470 msec for females (Atrial Fibrillation is allowed provided patients are rated controlled)

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Hypertension that cannot be controlled by medications
Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) - related illness or infectious hepatitis type A, B or C
Disease-free of prior malignancies for >= 2 years with exception of currently treated basal cell, squamous cell carcinoma of the skin, or carcinoma in-situ of the cervix
Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment
Pregnancy or breastfeeding (Female patients must be surgically sterile or postmenopausal, or must agree to use effective contraception during the period of therapy; all female patients with reproductive potential must have a negative pregnancy test [serum or urine] prior to enrollment)
Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy (The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

CCF-Fairview Hospital
Cleveland, Ohio, 44111
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: Phase II Single Arm, Open Label, Single Institution Study of Continuous Sunitinib (Sutent) in Patients With High-Risk (BCG-Refractory) Superficial Transitional Cell Carcinoma (TCC) of the Bladder

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with recurrent transitional cell bladder cancer.

Read the detailed description

PRIMARY OBJECTIVES:

To determine the clinical efficacy of oral sunitinib (Sutent) given continuously for a maximum of 12 weeks, with respect to complete response rates at 12 months after completion of treatment in patients with high-risk superficial bladder cancer who have failed previous intravesical BCG.

SECONDARY OBJECTIVES:

To assess the impact of sunitinib treatment in recurrence-free survival, progression-free survival, and overall survival in patients with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.

II. To evaluate the safety and tolerability of sunitinib (Sutent) administered in patients with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.

TERTIARY OBJECTIVES:

To assess pre-treatment tissue baseline angiogenic markers and to evaluate the magnitude of the difference among these variables with post-treatment tumor tissue after treatment with sunitinib (Sutent).

II. To evaluate the effects of Sunitinib (Sutent) on immunosuppressive regulatory T cells (Tregs).

III. To determine the presence of circulating tumor cells in superficial BCG-refractory TCC patients.

OUTLINE:

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Conditions: Recurrent Bladder Cancer, Transitional Cell Carcinoma of the Bladder
Being tested: sunitinib malate, immunohistochemistry staining method, TdT-mediated dUTP nick end labeling assay, light microscopy, laboratory biomarker analysis
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.

sunitinib malateDrug
Also called SU011248, SU11248, sunitinib, Sutent
Given orally
immunohistochemistry staining methodOther
Also called immunohistochemistry
Correlative studies
TdT-mediated dUTP nick end labeling assayOther
Also called TUNEL assay
Correlative studies
light microscopyOther
Correlative studies
laboratory biomarker analysisOther
Correlative studies

Study groups in NCT01118351
Study group	Role	What they receive
Arm I	Experimental	Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Receives: Drug: sunitinib malate; Other: immunohistochemistry staining method; Other: TdT-mediated dUTP nick end labeling assay; Other: light microscopy; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Complete Response Rate
Number of patients with complete response defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology 12 months after treatment with sunitinib.
Measured: At 12 months after completion of treatment

Secondary outcomes (4)

Recurrence-free Survival
Time from registration (up to 28 days prior to treatment) to the first documentation of recurrence assessed up to 12 months after completion of treatment (up to 12 weeks). Time period can be up to 16 months from time of registration.
Measured: at 12 months after completion of treatment
Progression-free Survival
Number of patients last known to be alive and not to have progressed are censored at the last day of contact. Progression is defined as: Biopsy proven muscle invasive disease ≥ Stage T2 or death due to any cause.
Measured: at 12 months after completion of treatment
Overall Survival
Number of patients still alive from date of registration to date of death due to any cause.
Measured: at 12 months after completion of treatment
Toxicity Assessed, Graded, and Tabulated Using CTCAE Version 3.0
Number of participants that experienced adverse events.
Measured: at 12 months after completion of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2008Sep 2015

First posted6 May 2010 (estimated)
Study startOct 2008
Primary completionJul 2012
Study completionSep 2015

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 Recurrent Bladder CancerStudies 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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01118351
Sponsor's protocol ID: CASE3808
Other IDs: NCI-2010-01137, CASE 3808-CC530
Status last verified: Apr 2019
First submitted: 5 May 2010
Last updated: 1 May 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Zahoor H, Mir MC, Barata PC, Stephenson AJ, Campbell SC, Fergany A, Dreicer R, Garcia JA. Phase II trial of continuous treatment with sunitinib in patients with high-risk (BCG-refractory) non-muscle invasive bladder cancer. Invest New Drugs. 2019 Dec;37(6):1231-1238. doi: 10.1007/s10637-018-00716-w. Epub 2019 Jun 24.
PubMed 31231785

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase II Single Arm, Open Label, Single Institution Study of Continuous Sunitinib (Sutent) in Patients With High-Risk (BCG-Refractory) Superficial Transitional Cell Carcinoma (TCC) of the Bladder
ClinicalTrials.gov ID: NCT01118351
Acronym / sponsor ID: CASE3808
Conditions: Recurrent Bladder Cancer, Transitional Cell Carcinoma of the Bladder
Phase: Phase 2
Study type: Interventional
Recruitment status: Terminated
Enrolment: 19 participants (actual)
Lead sponsor: Case Comprehensive Cancer CenterUniversity, hospital or other
Collaborators: Pfizer
Study start: Oct 2008
Primary completion: Jul 2012 (actual)
Study completion: Sep 2015 (actual)
First posted: 6 May 2010 (estimated)
Results: Posted 4 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

RATIONALE: Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well sunitinib malate works in treating patients with recurrent transitional cell bladder cancer.

Detailed description

PRIMARY OBJECTIVES:

To determine the clinical efficacy of oral sunitinib (Sutent) given continuously for a maximum of 12 weeks, with respect to complete response rates at 12 months after completion of treatment in patients with high-risk superficial bladder cancer who have failed previous intravesical BCG.

SECONDARY OBJECTIVES:

To assess the impact of sunitinib treatment in recurrence-free survival, progression-free survival, and overall survival in patients with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.

II. To evaluate the safety and tolerability of sunitinib (Sutent) administered in patients with high-risk superficial TCC of the bladder who have failed previous intravesical BCG.

TERTIARY OBJECTIVES:

To assess pre-treatment tissue baseline angiogenic markers and to evaluate the magnitude of the difference among these variables with post-treatment tumor tissue after treatment with sunitinib (Sutent).

II. To evaluate the effects of Sunitinib (Sutent) on immunosuppressive regulatory T cells (Tregs).

III. To determine the presence of circulating tumor cells in superficial BCG-refractory TCC patients.

OUTLINE:

Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up periodically.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm I	Experimental	Drug: sunitinib malate, Other: immunohistochemistry staining method, Other: TdT-mediated dUTP nick end labeling assay, Other: light microscopy, Other: laboratory biomarker analysisPatients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Patients must have clinically and histologically proven, recurrent superficial transitional cell carcinoma of the bladder after treatment with BCG therapy
Patients could have received previous any INTRAVESICAL therapy including BCG and/or IFN and/or chemotherapy up to 3 years prior to registration
Patients biopsy specimen should be available for review
ECOG PS 0-1 (Karnofsky greater than 70%)
Absolute neutrophil count >= 1,000/mcL

Key exclusion criteria (12 listed)

Prior systemic chemotherapy for bladder cancer; all other systemic chemotherapy must have been completed at least 3 years prior to enrollment
Prior treatment with any other anti-angiogenic therapy (including immunomodulatory agents such as thalidomide and lenalidomide, and anti-VEGF therapy with agents such as bevacizumab (Bevacizumab Avastin, Sunitinib (Sutent) and Sorafenib (Nexavar)
Prior major surgery (not TURBT/Cystoscopy), radiation therapy, or systemic therapy within 4 weeks of starting the study treatment
NCI CTCAE grade 3 hemorrhage within 4 weeks of starting study treatment
Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, 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
sunitinib malateAlso: SU011248, SU11248, sunitinib, SutentGiven orally	Drug	Arm I
immunohistochemistry staining methodAlso: immunohistochemistryCorrelative studies	Other	Arm I
TdT-mediated dUTP nick end labeling assayAlso: TUNEL assayCorrelative studies	Other	Arm I
light microscopyCorrelative studies	Other	Arm I
laboratory biomarker analysisCorrelative studies	Other	Arm I

Primary outcome

Complete Response Rate
Time frame: At 12 months after completion of treatment
Number of patients with complete response defined as negative cystoscopy with negative biopsy and no evidence of cancer on urine cytology 12 months after treatment with sunitinib.

4 secondary outcomes

Recurrence-free Survival
Time frame: at 12 months after completion of treatment
Progression-free Survival
Time frame: at 12 months after completion of treatment
Overall Survival
Time frame: at 12 months after completion of treatment
Toxicity Assessed, Graded, and Tabulated Using CTCAE Version 3.0
Time frame: at 12 months after completion of treatment

Results and safety

Results posted to the registry on 4 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I	19	15

Primary outcome: Complete Response Rate

Time frame: At 12 months after completion of treatment. Count of participants. Unit: Participants

Measure	Arm I n = 18
Value	4

Population analysed: All patients who received treatment and completed the 12 month follow up.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected while participants were on treatment (up to 12 weeks) and up to 1 year in follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I	3 of 19 (15.8%)	19 of 19 (100%)	0 of 19

Limitations and caveats (from the sponsor): Accrual to the study was suspended and trial was prematurely closed due to a predefined futility rule that was part of the study's initial statistical design.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31231785Zahoor H, Mir MC, Barata PC, Stephenson AJ, Campbell SC, Fergany A, Dreicer R, Garcia JA. Phase II trial of continuous treatment with sunitinib in patients with high-risk (BCG-refractory) non-muscle invasive bladder cancer. Invest New Drugs. 2019 Dec;37(6):1231-1238. doi: 10.1007/s10637-018-00716-w. Epub 2019 Jun 24.

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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.

Jorge Garcia, MD principal investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 16 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 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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. 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 4 Apr 2019). 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?

Complete Response Rate (time frame: At 12 months after completion of 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 NCT01118351, 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 1 May 2019; AzTrials last refreshed its copy on 29 Oct 2026.