Sunitinib in Treating Patients With Locally Advanced Bladder Cancer

Completed · Phase 2

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT00526656

Run by

Case Comprehensive Cancer Center

People needed

9

Starts

2007-09-01

Expected to finish

2011-03-01

Last updated by the study team

2019-04-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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:
• Inclusion criteria:
• 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
• Disease-free of prior malignancies for ≥ 5 years except for currently treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
• Exclusion criteria:
• NCI CTCAE grade 3 hemorrhage within 4 weeks of starting study treatment
• Any of the following within 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

Where it is running

• Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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