TriangleNCT00397488 · REGISTRY CONDITION SEARCH
Sunitinib in Treating Patients With Progressive Metastatic Transitional Cell Cancer of the Urothelium
Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.
- Phase
- PHASE2
- Status at capture
- COMPLETED
- Registry last update
- 2016-01-25
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.
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Who could take part
- 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)
- healthy Volunteers
- false
- maximum Age
- 120 Years
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- 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.
- intervention Names
- Drug: sunitinib malate
- label
- Sunitinib
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- Sunitinib
- name
- sunitinib malate
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 78
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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
- measure
- Overall Objective Response
- time Frame
- 2 years
Full study description
- 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.
Source references
Source notices and limitations
Discovery and provenance
- release id
- ctgov-registry-1336d216cbd1bbff780dac70
- edge id
- nct-edge-d5610a70c0d7bd0ef080
- requested nct id
- NCT00397488
- primary nct id
- NCT00397488
- source kind
- ctgov_condition_query
- source record id
- Source null
- source file sha256
- 308f79635904744c3081b7bece1bbf864685110f5917c0840a211e0e58d7fefc
- payload sha256
- c707750434bd869c76e17bda43cb2e5cd96c6a9b01934ad636e73e25a9c10f44
- payload
- clinical indication matching status
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- end exclusive
- true
- id
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- link basis
- returned_by_explicit_condition_and_posted_results_filter_query
- nct id
- NCT00397488
- occurrences
- context exact
- NCT00397488
- end
- 11
- exact text
- NCT00397488
- start
- 0
- offset unit
- unicode_code_points
- query cond
- Urethral Cancer
- query disease state id
- ds-urethral-cancer
- source file
- /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-urethral-cancer-000.json
- source file sha256
- 308f79635904744c3081b7bece1bbf864685110f5917c0840a211e0e58d7fefc
- source json pointer
- /studies/25/protocolSection/identificationModule/nctId
- source kind
- ctgov_condition_query
- source record id
- Source null
- source string basis
- parsed_JSON_string_unmodified
- source string sha256
- ceb7db1cc26f194c97e748b86241482097d374b17474557833b12258ecadd740
Preserved source evidence · Not medical advice