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NCT00001579 · ClinicalTrials.gov registry record · Phase 1
A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors
A Phase 1 study, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 1
- Development phase
- 50
- Enrollment target
NCT00001579: Completed Phase 1 study, sponsored by National Cancer Institute (NCI).
NCT00001579 is a Phase 1 study that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 50 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00001579, a Phase 1 study, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 50 participants
- Enrollment target
Study Summary
This is a dose escalation study. During the first period of this study, an initial pharmacological assessment of fluorouracil administered intravenously along with oral leucovorin calcium is made. Leucovorin calcium is given orally bid on days 1-3. Fluorouracil is given as a 24 hour infusion on day 2. After a 2 week rest period and resolution of any toxicities experienced during the first period of treatment, patients are given an escalating dose of fluorouracil with fixed doses of leucovorin calcium and ethynyluracil. Ethynyluracil and leucovorin calcium are given bid orally on days 1-3 of each week. Fluorouracil is given bid orally on day 2 of each week. Treatment is repeated for three weeks followed by a one week rest period. 3 to 6 patients are enrolled at each dose level. Dose escalation proceeds until the maximum tolerated dose (MTD) is determined. MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity.
Interventions
- DRUG Leucovorin
- DRUG 5-Fluorouracil
- DRUG Ethynyluracil
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 1997-06 |
| Est. Completion | 2001-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001579
The ClinicalTrials.gov registry entry for NCT00001579 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Cancer Institute (NCI), which has 3,257 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Leucovorin is the first listed.
NCT00001579 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00001579 about?
NCT00001579 is a clinical study titled "A Phase I Trial of 5-Fluorouracil Given With 776C85 (GW776) and Low-Dose Leucovorin in Adult Patients With Solid Tumors". This is a dose escalation study. During the first period of this study, an initial pharmacological assessment of fluorouracil administered intravenously along with oral leucovorin calcium is made. Leucovorin calcium is given orally bid on days 1-3. Fluorouracil is given as a 24 hour infusion on day...
What is the current status of trial NCT00001579?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 50 participants. The study started on 1997-06. Estimated completion is 2001-03.
What interventions are being tested in trial NCT00001579?
The interventions under investigation include: Leucovorin (DRUG), 5-Fluorouracil (DRUG), Ethynyluracil (DRUG).
Who is sponsoring clinical trial NCT00001579?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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