Sunitinib in Treating Patients With Locally Advanced Bladder Cancer

NCT00526656 | Completed Phase 2 Results DMC

• 3 other identifiers: CASE24806P30CA043703GA6180CV
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. PURPOSE: This phase II trial is studying the side effects and how well sunitinib works in treating patients with locally advanced bladder cancer.

Conditions

Bladder Cancer

Keywords

transitional cell carcinoma of the bladder; stage II bladder cancer; stage III bladder cancer; stage IV bladder cancer

Outcome Measures

Primary Outcomes (1)

• Pathologic Complete Response Rate of Sunitinib

  Number of participants who at the time of cystectomy, to have no evidence of tumor grossly and microscopically on routine Hematoxylin and Eosin stain (H\&E) (pathologic complete response or P0) will be defined as responders. All cases will be defined as responders (P0) or non-responders based on the presence of residual tumor. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progression (PD): At least a 20% increase in the sum of 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. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as reference the smallest sum LD since the treatment started.

  at 6 weeks

Secondary Outcomes (2)

• Evaluate Treatment to Surgical Complication and Morbidity

  following surgery at 6 weeks

• Time to Progression

  at 4 weeks post-surgery

Study Arms (1)

sunitinib malate

EXPERIMENTAL

Drug

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

50mg PO daily 4 weeks on -2 weeks off

Also known as: Drug

sunitinib malate

Eligibility Criteria

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

You may qualify if:

• Histological confirmed transitional cell carcinoma (TCC) of the bladder
• Patients with mixed tumors (i.e., tumors containing elements of squamous cell or adenocarcinoma) are eligible
• Patients with pure non-transitional cell carcinomas are not eligible
• Meets 1 of the following staging criteria:
• Tumors ≥ cT2
• Patients with cT2 lesions must have either a bulky or fixed lesion at the time of physical examination and/or scans
• Any cT stage with nodal-positive disease (documented by scans)
• Patients with (+) N1-N3 disease are eligible
• Candidate for radical cystectomy in ≥ 8 weeks while neoadjuvant sunitinib malate is administered

You may not qualify if:

• Any evidence of distant metastasis (excluding pelvic or retroperitoneal lymph nodes)
• PATIENT CHARACTERISTICS:
• ECOG performance status (PS) 0-1 (Karnofsky PS greater than 70%)
• Absolute neutrophil count ≥ 1,500/mcL
• Platelet count ≥ 100,000/mcL
• Hemoglobin ≥ 8.5 g/dL
• Total bilirubin ≤ 1.5 times institutional upper limit of normal (ULN)
• AST and ALT ≤ 3.5 times ULN
• Alkaline phosphatase ≤ 2.5 times ULN (≤ 10 times ULN in presence of bone metastasis)
• Serum calcium ≤ 12 mg/dL
• Creatinine ≤ 1.5 times ULN
• INR ≤ 1.5 (except for patients receiving warfarin therapy)
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Sunitinib; Pharmaceutical Preparations

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

Results Point of Contact

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

garciaj4@ccf.org

216-444-7774

Study Officials

• Jorge A. 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: September 5, 2007
• First Posted: September 10, 2007
• Study Start: September 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2011
• Last Updated: April 16, 2019
• Results First Posted: April 16, 2019

Record last verified: 2019-03

Locations

US (1)