Trial 0S-09-7

A Multi-Histology Phase II Study of 5-Fluoro-2’-Deoxycytidine with Tetrahydrouridine (FdCyd + THU).

Type: Cancer Therapy
Phase: Phase II
Status: Open to Accrual
Treatments: Chemotherapy: Systemic
Randomized: No
Defintions of terms and FAQ about clinical trials.

Trial Leaders/Researchers: Barbara Gitlitz, M.D.
Other Trial Staff: Charlean Ketchens, R.N., Lagrimas Ilagan, D.M., Gina Tse, R.N., Eduardo Mejia, D.M.

Staff may log in to see study documents.

You may participate in this study if:

	Requirement
1	Histologically documented metastatic or unresectable non-small cell lung cancer, head and neck cancer, urothelial transitional cell carcinoma, or breast cancer whose disease has progressed after at least one line of standard therapy
2	Measurable disease
3	Any prior therapy must have been completed at least 4 weeks prior to enrollment with complete recovery of all toxicities (at least six weeks out from nitrosoureas and mitomycin C). Prior radiation should have been completed 4 weeks prior to study enrollment with resolution of all associated toxicities to eligibility levels. Must be at least 2 weeks since any investigational agent treatment with recovery of toxicities to eligibility levels.
4	At least 18 years of age
5	Karnofsky performance status at least 60%
6	Life expectancy >3 months
7	AGC = / > 1.5; platelets = / > 100,000
8	Total bilirubin <1.5 x uln; SGOT/SGPT < / = 2.5 x uln
9	Creatinine <1.5 x uln OR creatinine clearance = / > 60 ml/min with creatinine levels >1.5 x uln
10	Signed an approved study-specific informed consent and HIPAA

You may not participate in this study if:

1	Concomitant treatment with any other investigational agents
2	Clinically significant illnesses which would compromise participation in the study, including, but not limited to, active or uncontrolled infection, immune deficiencies or confirmed diagnosis of HIV infection, Hepatitis B, Hepatitis C, or uncontrolled DM, uncontrolled HTN, symptomatic CHF, unstable angina pectoris, MI within the past 6 months, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
3	Pregnant or nursing women. Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation, and for 3 months after completion of study. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she or her partner should inform the treating physician immediately.
4	History of allergic reactions attributed to fluoropyrimidines (e.g., capecitabine, fluorouracil, fluorodeoxyuridine) or tetrahydrouridine

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.