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Randomized Blinded Phase II Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma

Phase 2
18 Years
Open (Enrolling)
Bladder Cancer

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Trial Information

Randomized Blinded Phase II Trial of Maintenance SUO11248 Versus Placebo Post Chemotherapy for Patients With Advanced Urothelial Carcinoma

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

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Time Frame:

six-month progression assessment post treatment

Safety Issue:


Principal Investigator

Maha H. Hussain, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan Cancer Center


United States: Institutional Review Board

Study ID:

UMCC 2005.145



Start Date:

May 2006

Completion Date:

June 2015

Related Keywords:

  • Bladder Cancer
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell



Cleveland Clinic Foundation Cleveland, Ohio  44195
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Weill Medical College of Cornell University New York, New York  10021
The University of Chicago Chicago, Illinois  60637
David Geffen School of Medicine at UCLA Los Angeles, California  90095
Columbia University Medical Center New York, New York  10032
Mayo Clinic - Rochester Rochester, Minnesota  55905