- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
California
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Los Angeles, California, Förenta staterna, 90095
- David Geffen School of Medicine at UCLA
-
-
Illinois
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Chicago, Illinois, Förenta staterna, 60637
- The University of Chicago
-
-
Michigan
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Ann Arbor, Michigan, Förenta staterna, 48109
- University of Michigan Comprehensive Cancer Center
-
-
Minnesota
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Rochester, Minnesota, Förenta staterna, 55905
- Mayo Clinic - Rochester
-
-
New York
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New York, New York, Förenta staterna, 10032
- Columbia University Medical Center
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New York, New York, Förenta staterna, 10021
- Weill Medical College of Cornell University
-
-
Ohio
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Cleveland, Ohio, Förenta staterna, 44195
- Cleveland Clinic Foundation
-
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Pennsylvania
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Philadelphia, Pennsylvania, Förenta staterna, 19104
- Abramson Cancer Center of the University of Pennsylvania
-
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Wisconsin
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Milwaukee, Wisconsin, Förenta staterna, 53226
- Medical College of Wisconsin
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
Andra namn:
|
Placebo-jämförare: 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.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Percentage of Participants That Experience Progression by 6 Months for Participants Receiving Sunitinib and Participants Receiving Placebo
Tidsram: 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
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Maha H. Hussain, M.D., University of Michigan Rogel Cancer Center
Publikationer och användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter histologisk typ
- Neoplasmer
- Carcinom
- Neoplasmer, körtel och epitel
- Karcinom, övergångscell
- Läkemedels fysiologiska effekter
- Molekylära mekanismer för farmakologisk verkan
- Enzyminhibitorer
- Antineoplastiska medel
- Angiogeneshämmare
- Angiogenesmodulerande medel
- Tillväxtämnen
- Tillväxthämmare
- Proteinkinashämmare
- Sunitinib
Andra studie-ID-nummer
- UMCC 2005.145
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