University of Southern California
USC Norris Comprehensive Cancer Center
If you are a patient, please contact Keck Medical Center of USC at 800-USC-CARE.

Trial 4B-06-1


A Phase I/II Study of E7389 Halichondrin B Analog (NSC #707389; IND #64395) in Metastatic Urothelial Tract Cancer and Renal Insufficiency.

Type: Treatment
Phase: Phase I/II
Status: Open to Accrual
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.
Trial Leaders/Researchers:  David Quinn, M.D.
Other Trial Staff:  Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Kristy Sartor Massopust, Coordinator, Ernesto Duverger, D.M.

Staff may log in to see study documents.


You may participate in this study if:
 Requirement
1Must have histologically or cytologically confirmed locally advanced or unresectable metastatic urothelial cancer
218 y/o and above
3Life expectancy at least 6 mos
4ECOG Performance Status 0-2
5Absolute Neutrophil must be more than 1000; Platelets must be more than 100,000; Hemoglobin must be more than or equal to 9.0
6Total bilirubin must be less than or equal to 1.5 ULN; AST/ALT must be less than or equal to 2.5 x ULN
7Men & women of child-bearing potential must use adequate contraception (hormonal, barrier method or abstinence)
8For Ph I of the study (Dose Levels 1 or 2): may have 2 or less prior treatments
9For Ph II of the study and Dose Level 3 of Ph I: Must have measurable disease. Must not have any prior therapy for advanced disease, except chemotherapy in the adjuvant setting & last dose must have been more than 6 mos
10Patients who are taking drugs that may affect the activity or PK of E7389 Halichondrin analog may be eligible after review
11Must sign Informed Consent (including HIPAA authorization)


You may not participate in this study if:
1On dialysis
2Taking other investigational agents
3Has untreated or unstable brain metastases
4Has uncontrolled intercurrent illness including: ongoing or active infection, symptomatic congestive heart failure, unstable angina, cardiac arrhythmia or psychiatric illness or social situations that would limit protocol compliance
5Pregnant or breastfeeding
6HIV positive and is on combination antiretroviral therapy or with CD4+ of less than or equal to 500/mm3



For further information on a study, please contact the Clinical Investigation Support Office at (323) 865-0451, or clinical.trials@med.usc.edu.

To schedule a consultation with the hospital, please call our New Patient Referrals Office at (323) 865-3111.