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Study Title: Stage IV Urothelial Cancer
Category: Cancer, General

Currently accepting participants?
Not at this time.

Principal Investigator: Jacqueline Vuky, MD
Study Coordinator: Gail Chumbley
Phone: (206) 583-6559 Ext.68710
Email: gchumbley@benaroyaresearch.org

What is the Stage IV Urothelial Cancer study?

Phase II, single arm, open investigation of the safety, efficacy and pharmacokinetics of the agent, AZD4877. Concentration: 5 mg/ml concentrate: 25 mg dose, 1 hour IV infusion once per week for 3 weeks. Dose preparation: 5.0 ml of 5 mg/ml added to 250 ml NaCl 0.9%. Pre Treatment: Anti-emetics, growth factors are allowed. Cycle: 4 week regimen. IV infusion each week for 3 weeks as long as tolerated per treating MD. Expected complications: - Fatigue - Nausea - Neutropenia - Thrombocytopenia - Anemia Less Common complications seen in individual patients: Chills, Pain – abdominal, pulmonary emboli, Pneumonia, Bleeding, Rash, Arial Fibrillation. Clinical tests: Pre dose hematology for all treatments Pre dose chemistry (+mg, +PO) & UA at C1, C2 and Q 3 months COAG (PT, PTT a nd INR)at screening. 12 L ECG at screening X 3 and C1D1 at end of dose. RECIST CT at screen, pre C3, then Q 8 weeks Research Labs: Pharmacokinetics Cycle 1 Day 1: Pre dose, 55 min after start and 5 min and 1 hour after end of infusion in clinic. Cycle 1 Day 8: Pre dose, 55 min after start. Assess patients' safety and tolerabililty. Collect information on lab tests and any complications.

Who can participate?

Patients diagnosed with advanced urothelial, transitional cell carcinoma of the following: - Bladder, renal pelvis, ureter, urethra. - Stage IV cancer, not amenable to surgery or radiotherapy. - Good kidney function: Serum creatinine should be adequate. - Adequate hematology and chemistry including liver Fx. - Measurable target lesions by CT.

What do I have to do as a study participant?

Provide written consent to participate in the study. Come into the VMMC clinic once a week for a one hour infusion through your port or IV. Allow research samples to be drawn at Cycle 1 and Cycle 2 (day 1 only). Allow quality of life assessments (answer questionnaires). Have a CT every 8 weeks. Allow follow-up telephone calls from research staff.

Study Summary:

Phase II study of the efficacy and safety of AZD4877 for recurrent stage IV urothelial transitional cell carcinoma. Jacqueline Vuky, MD is the PI.

Detailed Study Description:

Phase II study of the efficacy and safety of AZD4877 (AstraZeneca compound, non-FDA approved) for advanced urothelial transitional cell cancer. Mechanism of agent: Eg5 inhibition. Eg5 is a kinesin spindle protein, active during cell division. AZD4877 stops mitosis resulting in cell apoptosis (cell death). Population: Bladder, renal pelvis, ureter, urethra. Stage: IV not amenable to surgery or radiotherapy. Adequate hematology and chemistry including renal and liver function. Measurable target lesions. Cycle: 4 weeks. Agent: AZD4877 5 mg/ml concentrate. Dose: 25 mg, 1 hour IV infusion once a week for 3 weeks. 4th week is off. Restaging cy CT: Every 8 weeks. Allow research staff and MDs to follow your tolerance to agent and lab results.

Study Design: Interventional
Phase of Study: Phase II
Study Type: Interventional
Condition or Study Focus: Urothelial, predominantly Transitional Cell Carcinoma; advanced and recurrent. Not amenable to radiation therapy or surgery.
Intervention Type: Drug
Intervention Name: AZD4877
Gender: Male and Female
Age group: Interventional
Sponsor: AstraZeneca


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