Trial 0C-06-3

A Phase I Study of Halichondrin B Analog (E7389) in Combination with Cisplatin in Advanced Solid Tumors.

Type: Cancer Therapy
Phase: Phase I
Status: Closed to Accrual with Ongoing Follow-up
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: Heinz Josef Lenz, M.D.
Other Trial Staff: Susan Edwards, R.N., Anayansi Miloud, D.M., Xiomara Menendez, R.N., Arthur Alvarez, D.M., Arthur Alvarez, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Histologically confirmed metastatic or unresectable solid tumor for which standard curative or palliative measures do not exist or are no longer effective. Prior Cisplatin is allowed if cumulative dose is 300 mg/m2 (or less) .
2	Two (or less) prior chemotx regimens for advanced disease allowed.
3	18 y/o and above.
4	ECOG Performance Status 0-2.
5	Life expectancy more than 3 months.
6	Leukocytes 3,000 or higher; Absolute Neutrophil Count 1,500 or higher; Platelets 100,000 or higher.
7	Total bilirubin within normal; AST/ALT 2.5 (or less) x ULN.
8	Calculated Creatinine Clearance 60 mL/min or higher (Cockcroft-Gault method).
9	Eligibility of patients receiving medications or substances known to affect or with potential to affect activity or PK of E7389 or Cisplatin will be determined after PI review.
10	Women & men of childbearing potential must agree to use adequate contraception (hormonal, barrier, abstinence) prior to study entry & for the duration of study participation.
11	Signed Informed Consent (including HIPAA authorization).

You may not participate in this study if:

1	Chemotherapy, immunotherapy, targeted therapy or radiotherapy within 4 wks (6 wks for nitrosoureas or mitomycin C) prior to study entry.
2	Not recovered from toxicities due to agents administered more than 4 wks earlier.
3	Any other investigational agents. Bisphosphonates (e.g., pamidronate or zolendronate) will not be considered investigational for the purpose of eligibility.
4	Known active brain metastases.
5	Prior cumulative Cisplatin dose more than 300 mg/m2.
6	Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic CHF, unstable angina, cardiac arrhythmia, or psychiatric illness/social situations that would limit study compliance.
7	Pregnant or lactating females.
8	HIV positive, on combination antiretroviral tx.
9	Pre-existing Grade 2, or higher, neuropathy.

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.