Trials / Terminated
TerminatedNCT00044785
Phase I Study of PN401, Fluorouracil, Leucovorin and CPT-11 in Patients With Solid Tumors
A Phase I Study of Escalating Doses of CPT-11 and 5fluorouracil (5FU) Plus PN401 With a Fixed Dose of Leucovorin in Patients With Solid Tumor Malignancies.
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (planned)
- Sponsor
- Wellstat Therapeutics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
CPT-11 and 5Fluorouracil (5FU) combined with leucovorin has become the standard of care for colorectal cancer. PN401 permits treatment with higher than normal doses of 5FU, which could increase its therapeutic potential. It is hypothesized that adding PN401 to the CPT-11, 5FU, leucovorin regimen will reduce toxicity and will allow higher doses of 5FU to be well tolerated and therefore potentially increase effectiveness.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | triacetyluridine | |
| DRUG | fluorouracil | |
| DRUG | leucovorin | |
| DRUG | camptosar |
Timeline
- Start date
- 2002-08-01
- Completion
- 2004-03-01
- First posted
- 2002-09-06
- Last updated
- 2005-06-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00044785. Inclusion in this directory is not an endorsement.