Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma
Condition: Bladder Cancer
MeSH terms: Carcinoma, Transitional Cell
Intervention: SUTENT; Placebo
Intervention description: 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.
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 54.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This study is a randomized, blinded, placebo-controlled study evaluating the drug, SUO11248
      (SUTENT), for maintenance therapy in advanced urothelial cancer.
    

Eligibility criteria:

        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