Colorectal Neoplasms Clinical Trial
Official title:
A Phase II Study of Aroplatin in Subjects With Recurrent, Unresectable and Metastatic Colorectal Cancer Refractory to 5-Fluorouracil (5-FU)/Leucovorin or Capecitabine, and Irinotecan
To determine the rate of response and duration of reponse following therapy with Aroplatin in subjects with advanced colorectal cancer resistant to standard therapies. Secondary objectives are to determine safety and tolerability of the Aroplatin therapy.
Primary Objective:
- To determine response rate (RR; complete and partial response[CR,PR] and duration after
therapy with Aroplatin (Liposomal NDDP, L-NDDP) in subjects with locally recurrent,
unresectable or metastatic colorectal cancer refractory to 5-FU/leucovorin or
capecitabine, and irinotecan.
Secondary Objective:
- To determine safety and tolerability of the Aroplatin therapy.
This is a single-arm, open-label phase II study. Subjects refractory to 5-FU/leucovorin or
capecitabine, and irinotecan therapies will be enrolled. Dosing will be every four weeks
with individual dose escalations and adjustments for toxicity.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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