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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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00397488
Enrollment
78
Registered
2006-11-09
Start date
2006-09-30
Completion date
2012-02-29
Last updated
2016-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

DRUGsunitinib malate

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Pfizer
CollaboratorINDUSTRY
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Overall Objective Response2 yearsResponse 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

Countries

United States

Participant flow

Participants by arm

ArmCount
Sunitinib
Sunitinib in patients with metastatic urothelial carcinoma.
78
Total78

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyAdverse Event3
Overall StudyDeath1
Overall StudyWithdrawal by Subject3

Baseline characteristics

CharacteristicSunitinib
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
39 Participants
Age, Categorical
Between 18 and 65 years
39 Participants
Sex: Female, Male
Female
24 Participants
Sex: Female, Male
Male
54 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
67 / 78
serious
Total, serious adverse events
34 / 78

Outcome results

Primary

Overall Objective Response

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

Time frame: 2 years

ArmMeasureGroupValue (NUMBER)
SunitinibOverall Objective ResponsePartial Response (PR)3 participants
SunitinibOverall Objective ResponseStable Disease (SD)29 participants
SunitinibOverall Objective ResponseProgression of Disease (POD)39 participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026