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NCT00359606 · ClinicalTrials.gov registry record · Phase 1
5-Fluoro-2'-Deoxcyctidine and Tetrahydrouridine to Treat Patients With Advanced Cancer
A Phase 1 study of Neoplasms, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 1
- Development phase
- 58
- Enrollment target
- 4
- Study locations
NCT00359606: Completed Phase 1 study of Neoplasms, sponsored by City of Hope Medical Center.
NCT00359606 is a Phase 1 study of Neoplasms that has completed, run by City of Hope Medical Center. The registered enrollment target is 58 participants, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower). The trial reports 4 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00359606, a Phase 1 study of Neoplasms, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 58 participants
- Enrollment target
- 4
- Study locations
Study 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 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.
Primary Outcome
MTD is defined as the highest dose tested in which \< 33% of patients experienced dose limiting toxicity. The toxicities observed at each dose level will be summarized in terms of type (organ affected or laboratory determination such as absolute neutrophil count), severity (by National Cancer Institute Common Toxicity Criteria version 2.0 and nadir or maximum values for the laboratory measures), time of onset (i.e., cycle number), duration, and reversibility or outcome. Tables will be created to
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Pharmacological Study
- DRUG 5-Fluoro-2-Deoxycytidine (FdCyd)
- DRUG Tetrahydrouridine (THU)
Study Locations (4)
California
- City of Hope National Medical Center - Duarte
- USC/Norris Comprehensive Cancer Center - Los Angeles
- University of California, Davis Cancer Center - Sacramento
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 1999-04 |
| Est. Completion | 2012-06 |
| Phase | Phase 1 |
What the finished NCT00359606 record still lists
NCT00359606 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, below the 1,621-participant average among 158 other Neoplasms trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT00359606 reports a single indexed study location in California, Maryland.
Frequently Asked Questions
What is clinical trial NCT00359606 about?
NCT00359606 is a clinical study titled "5-Fluoro-2'-Deoxcyctidine and Tetrahydrouridine to Treat Patients With Advanced Cancer". 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 chem...
What is the current status of trial NCT00359606?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 58 participants. The study started on 1999-04. Estimated completion is 2012-06.
What conditions does trial NCT00359606 study?
This clinical trial studies the following conditions: Neoplasms.
What interventions are being tested in trial NCT00359606?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Pharmacological Study (OTHER), 5-Fluoro-2-Deoxycytidine (FdCyd) (DRUG), Tetrahydrouridine (THU) (DRUG).
Who is sponsoring clinical trial NCT00359606?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00359606 being conducted?
This trial has 4 study locations across California, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00359606's enrollment target sits among peer trials
58 97th of 158 higher than 60 of 158 other Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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