PHII-94/NCI#8351; A Multi-Histology Phase II Study of 5-Fluoro-2'-Deoxycytidine with Tetrahydrouridine (FdCyd+THU)

SUMMARY

You have been asked to participate in this research study because you have advanced cancer that has progressed after receiving standard treatment or for which no effective therapy exists. The purpose of this study is to evaluate the safety and effectiveness of FdCyd + THU in four types of cancer: non small cell lung cancer, breast cancer, bladder cancer and head and neck cancer. Repeated blood samples will be taken before and after the first dose of FdCyd + THU is given to study the levels of FdCyd + THU that stay in the body over time. Urine will be collected to measure the amount of the drugs in urine. Tumor biopsies will be obtained for laboratory tests to study the effect of the drug on tumor cells. Your treatment on this study is expected to last for as long as you are not having any unmanageable side effects and your tumor is no growing. After your treatment on this study is over, your medical condition will continue to be followed for 30 days.

FdCyd is a member of a class of anticancer drugs called fluoropyrimidines. Two other drugs in this class are 5-fluorouracil (5-FU) and 5-fluoro-2'-deoxyuridine (FUDR). FdCyd is thought to work by changing how genes work in cancer cells. FdCyd is rapidly broken down to the two known drugs FUDR and 5-FU by enzymes (proteins that speed up chemical reactions) in blood, liver and other tissues. It is desirable to slow down this reaction so that more FdCyd can get to the cancer cells before it is broken down. The drug THU is expected to slow the breakdown of FdCyd in the body, but is not expected to have any anticancer activity on its own. Breast cancer, non small cell lung cancer, bladder cancer and head and neck cancer all have the genes that FdCyd appears to change. On an earlier study in heavily pre-treated subjects, one subject with breast cancer achieved a 16 month partial response to treatment. Other subjects had stable disease.
 

COH Protocol Number : 09188

ClinicalTrials.gov Number : NCT00978250

Principal Investigator : Cristea, Mihaela M.D.

Sponsor : California Cancer Consortium (CCCP)--NCI

BRIEF ELIGIBILITY CRITERIA :

Eligible Ages : >=18

Gender : Either

Treatment Intent : Non-Adjuvant treatment

Prior Chemotherapy : Breast: Allowed

Brain Metastases :

Measurable Disease : Breast: Required