5-Fluoro-2'-Deoxcyctidine and Tetrahydrouridine to Treat Patients With Advanced Cancer

Completed · Phase 1

Conditions studied: Neoplasms

In brief

This phase I trial studies the side effects and best dose of 5-fluoro-2-deoxycytidine when given together with tetrahydrouridine in treating patients with solid tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced). Drugs used in chemotherapy, such as 5-fluoro-2-deoxycytidine and tetrahydrouridine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Key facts

Study ID: NCT00359606
Run by: City of Hope Medical Center
People needed: 58
Starts: 1999-04-01
Expected to finish: 2012-06-01
Last updated by the study team: 2015-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Advanced, histologically-confirmed neoplastic disease refractory to standard therapy or for which no standard therapy exists
Karnofsky performance status of at least 60% and estimated survival of at least two months
Serum creatinine =< 2.0 mg/dl or creatinine clearance >= 50 ml/min
Absolute neutrophil count (ANC) >= 1,500/ul
Platelets >= 125,000/ul
Bilirubin =< 1.5 mg/dl
Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =< 3 times the upper limits of normal
Prior antineoplastic therapy must have been completed at least four weeks prior to the patient's entry on this study, or patients must have recovered from any expected side effects of the prior therapy; there is no limit on the number of cycles of prior chemotherapy
Patients must be ineligible for or have refused participation in higher priority institutional protocols
Written, voluntary, informed consent of the patient must be obtained in compliance with institutional, state and federal guidelines
Pregnant patients are INELIGIBLE; all patients of child-bearing potential, both male and female, must be advised to practice adequate contraception; premenopausal women must have a negative pregnancy test prior to entry on this study
Patients with any non-malignant intercurrent illness (e.g. cardiovascular, pulmonary, or central nervous system disease) which is either poorly controlled with currently available treatment, or which is of such severity that the investigators deem it inappropriate to treat the patient on this protocol are INELIGIBLE
Patients currently being treated for a severe infection or who are recovering from major surgery are INELIGIBLE until recovery is deemed complete by the investigators
The presence of measurable disease is NOT required for this phase I study; if bidimensionally measurable disease is present, baseline measurements of up to 3 indicator lesions should be made no earlier than four weeks prior to the first cycle of chemotherapy; pleural effusions, ascites and bone metastases are not considered measurable
Complete blood count (CBC), differential count, platelet count, and blood chemistries should be done no earlier than 72 hours prior to each cycle of chemotherapy
Pretreatment tests should be done no earlier than two weeks prior to the first cycle of chemotherapy
Priority for accrual will be given to patients with breast cancer due to the in vitro data suggesting potential activity for this disease

Where it is running

City of Hope National Medical Center — Duarte, California, United States
USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
University of California, Davis Cancer Center — Sacramento, California, United States
National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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