Clinical trial NCT00397488: Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
Official title: Phase II Study of Sunitinib in Metastatic Transitional Cell Carcinoma of the Urothelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Keywords: recurrent bladder cancer
stage IV bladder cancer
transitional cell carcinoma of the bladder
anterior urethral cancer
posterior urethral cancer
recurrent urethral cancer
metastatic transitional cell cancer of the renal pelvis and ureter
recurrent transitional cell cancer of the renal pelvis and ureter
urethral cancer associated with invasive bladder cancer
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Pfizer
First posted: 2006-11-09
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Histologically confirmed transitional cell carcinoma of the urothelium, including 1 of the following sites:

  * Bladder
  * Urethra
  * Ureter
  * Renal pelvis
* Progressive metastatic disease

  * Progressive disease defined as new or progressive lesions on cross-sectional imaging
  * Progressed despite prior treatment with cytotoxic chemotherapy
* Measurable disease
* Previously treated disease, as defined by the following:

  * Received treatment with 1-4 cytotoxic agents
  * Prior therapy must have included ≥ 1 of the following:

    * Cisplatin
    * Carboplatin
    * Paclitaxel
    * Docetaxel
    * Gemcitabine hydrochloride
  * Prior cytotoxic agents in the perioperative or metastatic setting allowed and may have been administered sequentially (e.g., first-line treatment followed by second-line treatment at time of progression) or all as part of a single regimen
* No symptomatic CNS metastases

PATIENT CHARACTERISTICS:

* Karnofsky performance status 60-100%
* Absolute neutrophil count ≥ 1,000/mm³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 8.0 g/dL
* Bilirubin ≤ 1.5 mg/dL (unless Gilbert's disease is present)
* AST and ALT ≤ 2.5 times upper limit of normal (ULN) (5 times ULN if liver function abnormalities are due to underlying malignancy)
* Creatinine ≤ 2.0 mg/dL
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* None of the following within the past 6 months:

  * Myocardial infarction
  * Severe or unstable angina
  * Coronary or peripheral artery bypass graft
  * Symptomatic congestive heart failure
  * Cerebrovascular accident or transient ischemic attack
  * Pulmonary embolism
* No ongoing cardiac dysrhythmias ≥ grade 2
* No prolonged QTc interval on baseline ECG
* No uncontrolled hypertension, defined as blood pressure \> 150/100 mm Hg despite optimal medical therapy
* No preexisting thyroid abnormality (i.e., thyroid function tests that cannot be maintained in the normal range with medication)
* No known HIV- or AIDS-related illness or other active infection

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy or chemotherapy
* At least 4 weeks since prior major surgery
* No other concurrent investigational drugs
* No concurrent participation in another clinical trial (supportive care trials or non-treatment trials \[e.g., quality of life\] allowed)
* No concurrent therapeutic doses of warfarin (low-dose warfarin ≤ 2 mg once daily for thromboembolic prophylaxis allowed)

Primary outcomes:
measure: Overall Objective Response
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Dean F. Bajorin, MD
role: PRINCIPAL_INVESTIGATOR
References: