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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Carcinoma, Transitional Cell

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Urethral Neoplasms

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Urogenital Neoplasms

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Female Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Neoplasms, Glandular and Epithelial

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Transitional Cell Cancer of the Renal Pelvis and Ureter

Urethral Cancer

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All Drugs and Chemicals

Sunitinib

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

This is a phase II trial of Sunitinib in patients with metastatic urothelial carcinoma. Sunitinib will be administered at a dose of 50 mg orally once daily for four consecutive weeks followed by a two-week rest period for the initial population. A second cohort of patients will be enrolled, who will receive 37.5 mg of sunitinib orally, on a continuous dosing schedule. Intra-patient dose reduction may be required depending on the type and severity of individual toxicity encountered. Re-staging imaging studies will be performed after every cycle of treatment during the first 4 cycles and subsequently after every other cycle. Patients may continue on study as long as they are tolerating therapy and in the absence of disease progression.

sunitinib malate

Dean F. Bajorin, MD

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

PURPOSE: This phase II trial is studying how well sunitinib works in treating patients with progressive metastatic transitional cell cancer of the urothelium.

OBJECTIVES:

Primary

* Determine the response rate in patients with progressive metastatic transitional cell carcinoma of the urothelium treated with sunitinib malate.
* Determine the safety of this regimen in these patients.

Secondary

* Determine the time to disease progression in patients treated with this regimen.

  * To determine time to tumor progression (TTP) for sunitinib malate on a continuous dosing schedule for treatment of metastatic urothelial carcinoma.
  * To estimate sunitinib and SU012662 trough plasma concentration (Ctrough) data for the continuous daily schedule and to determine potential association with efficacy and safety.

Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium

Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium

Response rate as measured by RECIST criteria. The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for PD the smallest measurements recorded since the treatment started). In general, the patient's best response assignment will depend on the achievement of both measurement and confirmation criteria

Spots Global Cancer Trial Database for Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium

Trial Identification

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Study Description

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