Aroplatin and Capecitabine in Patients With Advanced Colorectal Cancer Resistant to Standard Therapies

Phase 1

• Conditions: Colorectal Neoplasms

• Registration Number: NCT00081536
• Lead Sponsor: Aronex Pharmaceuticals

Brief Summary

This study is a Phase I/II study. In Phase I of this study, the objective is to determine the maximum tolerated dose (MTD) of combination therapy with Aroplatin and capecitabine in subjects with unresectable, local recurrence or distant metastases of colorectal cancer refractory to 5-FU/leucovorin and irinotecan. In Phase II, the primary objective is to evaluate the response proportion and duration with Aroplatin/capecitabine therapy. Secondary objectives are to evaluate frequency and severity of adverse events.

Detailed Description

Phase I Primary Objective:

* Determine the MTD of Aroplatin/capecitabine subjects with unresectable local recurrence or distant metastases of colorectal cancer refractory to 5-FU/LV and irinotecan.

Phase II Primary Objective:

* Evaluate the response proportion and duration with Aroplatin/capecitabine therapy.

Phase II Secondary Objective:

* Evaluate the frequency of adverse events.

Study Timeline

• Status Verified: 2004-04
• Study First Submitted: 2004-04-15
• Study First Submitted QC: 2004-04-19
• Study First Posted: 2004-04-20
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER