Trials / Completed
CompletedNCT00004860
Fluorouracil-Uracil and Leucovorin in Treating Elderly Patients With Metastatic Colorectal Cancer
A Phase II Study of ORZEL (UFT + Leucovorin) in Elderly (at Least 75 Years Old) Patients With Colorectal Cancer
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Eastern Cooperative Oncology Group · Network
- Sex
- All
- Age
- 75 Years – 120 Years
- Healthy volunteers
- Not accepted
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of fluorouracil-uracil and leucovorin in treating elderly patients who have metastatic colorectal cancer.
Detailed description
OBJECTIVES: I. Determine the response rate of elderly patients with metastatic colorectal cancer treated with fluorouracil-uracil and leucovorin calcium (Orzel). II. Evaluate the toxicity profile of this regimen in this patient population. III. Compare response rates obtained in this study with those observed in recent phase III studies in younger patients. OUTLINE: Patients receive oral fluorouracil-uracil and oral leucovorin calcium (Orzel) every 8 hours for 28 days. Courses repeat every 35 days in the absence of unacceptable toxicity or disease progression. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 20-55 patients will be accrued for this study within 1 year.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | leucovorin calcium | |
| DRUG | tegafur-uracil |
Timeline
- Start date
- 2000-10-09
- Primary completion
- 2005-10-01
- First posted
- 2004-04-12
- Last updated
- 2023-06-15
Locations
51 sites across 2 countries: United States, Puerto Rico
Source: ClinicalTrials.gov record NCT00004860. Inclusion in this directory is not an endorsement.