Trials / Unknown
UnknownNCT00024401
DHA-Paclitaxel in Treating Patients With Metastatic Colorectal Cancer
Phase II Open-Label Study of Taxoperxin (DHA-Paclitacel) Injection by 2-Hour Intravenous Infusion in Patients With Metastatic Cancer of the Colon/Rectum
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- Theradex · Industry
- Sex
- All
- Age
- 18 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. PURPOSE: Phase II trial to study the effectiveness of DHA-paclitaxel in treating patients who have metastatic colorectal cancer.
Detailed description
OBJECTIVES: I. Determine the objective tumor response rate, duration of response, and time to disease progression in patients with metastatic colorectal cancer treated with DHA-paclitaxel. II. Determine the overall survival of patients treated with this drug. III. Determine the toxicity profile of this drug in these patients. IV. Assess the quality of life of patients treated with this drug. OUTLINE: This is a multicenter study. Patients receive DHA-paclitaxel IV over 2 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, every 2 courses, and at end of study treatment. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 18-50 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | DHA-paclitaxel |
Timeline
- Start date
- 2001-05-01
- First posted
- 2004-01-15
- Last updated
- 2008-07-24
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00024401. Inclusion in this directory is not an endorsement.