Status:
COMPLETED
5-Fluoro-2'-Deoxcyctidine and Tetrahydrouridine to Treat Patients With Advanced Cancer
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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...
Detailed Description
PRIMARY OBJECTIVES: I. To determine the maximum tolerated dose (MTD) of 5-fluoro-2'-deoxycytidine (5-fluoro-2-deoxycytidine) (FdCyd) administered by intravenous (IV) infusion over three hours with co...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- 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
Exclusion
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00359606
Start Date
April 1 1999
End Date
June 1 2012
Last Update
May 6 2015
Active Locations (4)
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1
City of Hope National Medical Center
Duarte, California, United States, 91010
2
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90089
3
University of California, Davis Cancer Center
Sacramento, California, United States, 95817
4
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892