Sunitinib Malate in Treating Patients With Recurrent Transitional Cell Bladder Cancer

NCT01118351 | Terminated Phase 2 Results DMC

• 3 other identifiers: CASE3808NCI-2010-01137CASE 3808-CC530
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Recurrent Bladder Cancer; Transitional Cell Carcinoma of the Bladder

Outcome Measures

Primary Outcomes (1)

• 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.

  At 12 months after completion of treatment

Secondary Outcomes (4)

• Recurrence-free Survival

  at 12 months after completion of treatment

• Progression-free Survival

  at 12 months after completion of treatment

• Overall Survival

  at 12 months after completion of treatment

• Toxicity Assessed, Graded, and Tabulated Using CTCAE Version 3.0

  at 12 months after completion of treatment

Other Outcomes (2)

• Immune Response

  at 12 months after completion of treatment

• Angiogenesis

  at 12 months after completion of treatment

Study Arms (1)

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.

Drug: sunitinib malate; Other: immunohistochemistry staining method; Other: TdT-mediated dUTP nick end labeling assay; Other: light microscopy; Other: laboratory biomarker analysis

Interventions

sunitinib malate DRUG

Given orally

Also known as: SU011248, SU11248, sunitinib, Sutent

Arm I

immunohistochemistry staining method OTHER

Correlative studies

Also known as: immunohistochemistry

Arm I

TdT-mediated dUTP nick end labeling assay OTHER

Correlative studies

Also known as: TUNEL assay

Arm I

light microscopy OTHER

Correlative studies

Arm I

laboratory biomarker analysis OTHER

Correlative studies

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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)
• 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)

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• Pfizer: collaborator

Study Sites (2)

CCF-Fairview Hospital

Cleveland, Ohio, 44111, United States

Location

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

Related Publications (1)

• 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.

  PMID: 31231785 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Sunitinib; Immunohistochemistry; Microscopy

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Diagnostic Imaging

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Jorge Garcia
• Organization: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

garciaj4@case.edu

216-444-7774

Study Officials

• Jorge Garcia, MD

  Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 6, 2010
• Study Start: October 1, 2008
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2015
• Last Updated: May 1, 2019
• Results First Posted: April 4, 2019

Record last verified: 2019-04

Locations

US (2)