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Investigator(s):
James H. Doroshow, M.D. Principal Investigator Phone: 301-496-4291 Fax: 301-496-0826 doroshoj@mail.nih.gov	Shivaani Kummar, M.D., F.A.C.P. Protocol Chair Phone: 301-435-0517 Fax: 301-496-0826 kummars@mail.nih.gov
Referral Contact(s):
Janelle Bingham, R.N. Research Nurse Phone: 301-435-2715 Fax: 301-451-5433 jbingham@mail.nih.gov	Deborah Allen, R.N., O.C.N. Research Nurse Phone: 301-402-5640 Fax: 301-480-7281 allendeb@mail.nih.gov	Lemual Clayborn Research Coordinator Phone: 301-451-0992 Fax: 301-496-0826 claybornlr@mail.nih.gov

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Key Eligibility Criteria:

• Histologically documented metastatic or unresectable non-small cell lung cancer, head and neck cancer, bladder cancer, or breast cancer
• Progressive disease after at least one line of standard therapy
• Measurable disease, defined as ≥ 1 lesions that can be accurately measured in ≥ 1 dimensions as ≥ 20 mm with conventional techniques or as ≥ 10 mm with spiral CT scan
• ≥ 18 years of age
• Karnofsky performance status ≥ 60%
• Absolute neutrophil count ≥ 1,500/mcL
• Platelets ≥ 100,000/mcL
• Total bilirubin < 1.5 x institutional upper limit of normal (ULN)
• AST/ALT ≤ 2.5 x ULN
• Creatinine < 1.5 x ULN OR creatinine clearance ≥ 60 mL/min for patients with creatinine levels ≥ 1.5 x ULN
• Not pregnant or nursing; must agree to use adequate contraception for the duration of study participation and for 3 months after completion of study
• No other investigational agents
• No medical conditions that would preclude study participation
• No history of allergic reactions attributed to fluoropyrimidines

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Study Outline:

• FdCyd and THU are given through a vein for about 3 hours each day on days 1–5 and 8–12 of each 28-day period (cycle)
• Cycles continue in the absence of disease progression or unacceptable toxicity
• Patients will undergo a number of tests and procedures during the treatment cycle, including physical examinations, blood and urine samples for standard tests, imaging studies (ultrasound, magnetic resonance imaging (MRI), or computed tomography (CT) scans)

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/12/12
Updated: 9/20/12