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 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: Closed to Accrual with Ongoing Follow-up
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
1Histologically 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
2Measurable disease
3Any 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.
4At least 18 years of age
5Karnofsky performance status at least 60%
6Life expectancy >3 months
7AGC = / > 1.5; platelets = / > 100,000
8Total bilirubin <1.5 x uln; SGOT/SGPT < / = 2.5 x uln
9Creatinine <1.5 x uln OR creatinine clearance = / > 60 ml/min with creatinine levels >1.5 x uln
10Signed an approved study-specific informed consent and HIPAA


You may not participate in this study if:
1Concomitant treatment with any other investigational agents
2Clinically 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.
3Pregnant 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.
4History 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.