Trials / Completed
CompletedNCT00004931
Fluorouracil Plus Leucovorin With or Without Oxaliplatin in Treating Patients With Stage II or Stage III Colon Cancer
A Clinical Trial Comparing 5-Fluorouracil (5-FU) Plus Leucovorin (LV) and Oxaliplatin With 5-FU Plus LV for the Treatment of Patients With Stages II and III Carcinoma of the Colon
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 2,472 (estimated)
- Sponsor
- National Cancer Institute (NCI) · NIH
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
Randomized phase III trial to compare the effectiveness of fluorouracil plus leucovorin with or without oxaliplatin in treating patients who have stage II or stage III colon cancer. 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. It is not yet known which combination chemotherapy regimen is more effective for colon cancer
Detailed description
PRIMARY OBJECTIVES: I. To compare the relative efficacy of 5-FU + LV + Oxaliplatin (FLOX) with that of 5-FU + LV (FL) in prolonging DFS. SECONDARY OBJECTIVES: I. To compare the relative efficacy of FLOX with FL in prolonging S. OUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. ARM I: Patients receive leucovorin calcium IV over 2 hours and fluorouracil IV (administered after 1 hour of leucovorin calcium) weekly for 6 weeks. ARM II: Patients receive oxaliplatin IV over 2 hours on days 1, 15, and 29 and leucovorin calcium and fluorouracil as in arm I. Treatment in both arms repeats every 8 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 6, 9, and 12 months; every 6 months for 4 years; and then annually thereafter.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | leucovorin calcium | Given IV |
| DRUG | fluorouracil | Given IV |
| DRUG | oxaliplatin | Given IV |
| OTHER | laboratory biomarker analysis | Correlative studies |
Timeline
- Start date
- 2000-02-01
- Primary completion
- 2005-09-01
- First posted
- 2003-05-14
- Last updated
- 2013-01-14
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00004931. Inclusion in this directory is not an endorsement.