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
Sponsor: Theradex
Listed as NCT00024401, this PHASE2 trial focuses on Colorectal Cancer and remains ongoing. Sponsored by Theradex, it has been updated 6 times since 2001, reflecting limited change activity. This study contributes to the evolving evidence base for cancer treatment protocols.
Study Description(click to expand)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.
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.
Status Flow
Change History
6 versions recorded-
Sep 2025 — Present [monthly]
Unknown PHASE2
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Sep 2024 — Sep 2025 [monthly]
Unknown PHASE2
-
Jul 2024 — Sep 2024 [monthly]
Unknown PHASE2
Status: Unknown Status → Unknown
-
Jan 2021 — Jul 2024 [monthly]
Unknown Status PHASE2
-
Jun 2018 — Jan 2021 [monthly]
Unknown Status PHASE2
▶ Show 1 earlier version
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Jan 2017 — Jun 2018 [monthly]
Unknown Status PHASE2
First recorded
May 2001
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Theradex
For direct contact, visit the study record on ClinicalTrials.gov .