- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00393796
Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
Randomized Blinded Phase II Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
Studieoversikt
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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California
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Los Angeles, California, Forente stater, 90095
- David Geffen School of Medicine at UCLA
-
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Illinois
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Chicago, Illinois, Forente stater, 60637
- The University of Chicago
-
-
Michigan
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Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan Comprehensive Cancer Center
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-
Minnesota
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Rochester, Minnesota, Forente stater, 55905
- Mayo Clinic - Rochester
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New York
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New York, New York, Forente stater, 10032
- Columbia University Medical Center
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New York, New York, Forente stater, 10021
- Weill Medical College of Cornell University
-
-
Ohio
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Cleveland, Ohio, Forente stater, 44195
- Cleveland Clinic Foundation
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19104
- Abramson Cancer Center of the University of Pennsylvania
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Wisconsin
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Milwaukee, Wisconsin, Forente stater, 53226
- Medical College of Wisconsin
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Histologic/cytologic diagnosis of urothelial carcinoma (transitional cell carcinoma either pure or mixed histology)
- All patients must have received four - six cycles of standard first line chemotherapy (protocol details suggested combinations) for treatment of locally recurrent or metastatic disease AND must have achieved stable disease (SD), partial response (PR), or complete response (CR) to this chemotherapy.
- Type of response, number of cycles and specific regimen given must be carefully recorded and submitted at time of registration.
- Reports from pre and post treatment imaging will be required at time of registration to document response.
- Patients must be registered within 1 month (or the next business day if falls on a weekend or holiday) of scans demonstrating stable disease or better and no more than 42 days after receiving the last standard chemotherapy dose. For example, if patients are receiving treatment on days 1 and 8 of each cycle, day 8 of the last cycle would be considered the last standard chemotherapy dose.
- Patients may have received previous adjuvant or neoadjuvant therapy.
- No prior antiangiogenic therapy for this stage of the disease.
Exclusion Criteria:
- Major surgery within 4 weeks of starting the study treatment.
- NCI CTCAE grade 3 hemorrhage or higher within 4 weeks of starting the study treatment.
- History of or known spinal cord compression, or carcinomatous meningitis, or evidence of symptomatic brain or leptomeningeal disease on screening CT or MRI scan. However treated, stable and asymptomatic brain metastases are allowed.
- Known HIV - positive patients may not participate. This is to avoid additional complications that immune suppression and HIV infection may cause due to the intense nature of the chemotherapy in this trial.
- Any of the following within 6 months prior to study administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure (CHF), cerebrovascular accident or transient ischemic attack, or pulmonary embolism.
- Patients with history of or who are suspected to have CHF can be included as long as they are asymptomatic and have an ejection fraction that is equal to or above the institutional lower limit of normal by baseline MUGA(obtained within one month of registration or the next business day if falls on a weekend or holiday).
- Ongoing cardiac dysrhythmias of NCI CTCAE Grade > 2.
- Unresolved bacterial infection.
- Uncontrolled hypertension.
- Pre-existing thyroid abnormality that can not be controlled medically.
- Concurrent treatment on another clinical trial.
- Pregnant or breast-feeding
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: SUTENT
Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
|
50 mg/PO once daily for four consecutive weeks with a two week rest period.
Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded.
Participants receiving SU011248 will be removed from the study.
Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
Andre navn:
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Placebo komparator: Placebo
Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
|
50 mg/PO once daily for four consecutive weeks with a two week rest period.
Study participants who show evidence of disease progression (or are considered for removal from study for any other reason) will be unblinded.
Participants receiving SU011248 will be removed from the study.
Participants receiving placebo will be given the opportunity to "crossover" and receive SU011248.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo
Tidsramme: 6 Months Post Treatment
|
The primary endpoint of this unblinded, randomized trial is to compare the 6-month progression rate in patients randomized to maintenance SU011248 as compared with placebo following primary chemotherapy. Progression is defined as a 20% increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. |
6 Months Post Treatment
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Maha H. Hussain, M.D., University of Michigan Rogel Cancer Center
Publikasjoner og nyttige lenker
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
Ytterligere relevante MeSH-vilkår
- Neoplasmer etter histologisk type
- Neoplasmer
- Karsinom
- Neoplasmer, kjertel og epitel
- Karsinom, overgangscelle
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antineoplastiske midler
- Angiogenese-hemmere
- Angiogenesemodulerende midler
- Vekststoffer
- Veksthemmere
- Proteinkinasehemmere
- Sunitinib
Andre studie-ID-numre
- UMCC 2005.145
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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