DAVANAT Plus 5-Fluorouracil as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer

Condition
Colorectal Cancer

Treatment or Intervention
Drug: DAVANAT plus 5-Fluorouracil

Phase
Phase II

Purpose:
This is a Phase II, multi-center study of a carbohydrate (DAVANAT) which has been shown to increase the anti-tumor activity of 5-fluorouracil (5-FU) in mice. 5-FU is a chemotherapy drug commonly used in cancer patients. A Phase I study of 40 patients showed that DAVANAT in different doses plus 5-FU was well tolerated in patients with different types of solid tumors who failed standard, approved treatments. In this Phase II study, patients with colon cancer which has spread, despite treatment with approved therapies, will receive DAVANAT plus 5-FU in monthly cycles for at least 2 cycles or until their disease progresses. The main reason for doing the study is to test the efficacy of this drug combination to shrink tumors or prevent further growth.

Related Topics:
MedlinePlus related topics: Colorectal Cancer
Genetics Home Reference related topics: Colorectal Cancer

Study Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Official Title:
A Phase II, Multi-Center, Open-Label Trial to Evaluate the Efficacy and Safety of Intravenous DAVANAT in Combination With 5-Fluorouracil When Administered in Monthly Cycles as Third- or Fourth-Line Therapy for Metastatic Colorectal Cancer

Further Study Details
• Primary Outcomes: frequency of objective complete or partial tumor response, as characterized by Response Evaluation Criteria in Solid Tumors (RECIST) criteria; frequency of stable and progressive disease
• Secondary Outcomes: safety of DAVANAT plus 5-FU; ancillary clinical indicators including Eastern Cooperative Oncology Group (ECOG) performance, carcinoembryonic antigen (CEA) levels, and quality of life
• Expected Total Enrollment: 33
• Study start: May 2005