- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00397488
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
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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
-
-
New York
-
New York, New York, Forente stater, 10021
- Memorial Sloan-Kettering Cancer Center
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: Sunitinib
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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Overall Objective Response
Tidsramme: 2 years
|
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
|
2 years
|
Samarbeidspartnere og etterforskere
Etterforskere
- Hovedetterforsker: Dean F. Bajorin, MD, Memorial Sloan Kettering Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
- tilbakevendende blærekreft
- stadium IV blærekreft
- metastatisk overgangscellekreft i nyrebekkenet og urinlederen
- tilbakevendende overgangscellekreft i nyrebekkenet og urinlederen
- overgangscellekarsinom i blæren
- tilbakevendende kreft i urinrøret
- urinrørskreft assosiert med invasiv blærekreft
- kreft i fremre urinrør
- bakre urinrørskreft
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Urologiske neoplasmer
- Urogenitale neoplasmer
- Neoplasmer etter nettsted
- Nyresykdommer
- Urologiske sykdommer
- Karsinom
- Neoplasmer, kjertel og epitel
- Urinblæresykdommer
- Ureteriske sykdommer
- Uretrale sykdommer
- Nyre-neoplasmer
- Neoplasmer i urinblæren
- Karsinom, overgangscelle
- Ureterale neoplasmer
- Urethrale neoplasmer
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Proteinkinasehemmere
- Sunitinib
Andre studie-ID-numre
- 06-081
- MSKCC-06081
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