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 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.
- 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
United States: Food and Drug Administration
|Arizona Cancer Center||Tucson, Arizona 85724|
|University Medical Center||Tucson, Arizona 85724|