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: Cancer Therapy
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., Ernesto Duverger, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Must have histologically or cytologically confirmed locally advanced or unresectable metastatic urothelial cancer
2	18 y/o and above
3	Life expectancy at least 6 mos
4	ECOG Performance Status 0-2
5	Absolute Neutrophil must be more than 1000; Platelets must be more than 100,000; Hemoglobin must be more than or equal to 9.0
6	Total bilirubin must be less than or equal to 1.5 ULN; AST/ALT must be less than or equal to 2.5 x ULN
7	Men & women of child-bearing potential must use adequate contraception (hormonal, barrier method or abstinence)
8	For Ph I of the study (Dose Levels 1 or 2): may have 2 or less prior treatments
9	For 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
10	Patients who are taking drugs that may affect the activity or PK of E7389 Halichondrin analog may be eligible after review
11	Must sign Informed Consent (including HIPAA authorization)

You may not participate in this study if:

1	On dialysis
2	Taking other investigational agents
3	Has untreated or unstable brain metastases
4	Has 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
5	Pregnant or breastfeeding
6	HIV 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.