Study of Perifosine + Capecitabine for Colon Cancer Patients

• D-21266
• KRX-0401

• Xeloda

The maximum tolerated dose (MTD) is defined in which fewer than 33% of patients experienced dose limiting toxicity (DLT) attributable to the study drug(s), when at least six patients were treated at that dose and are evaluable for toxicity. A DLT will be defined as any of the following deemed to be related to study drug(s):

• Grade 3 non-hematologic toxicity except alopecia not reversible to Grade 2 or less within 96 hours
• Any Grade 4 toxicity DLT will be based on the first cycle of treatment (first 21 days). Toxicity will be graded according to the NCI CTCAE version 3.0. To be evaluable for toxicity, a patient must receive at least 1 complete course of treatment or have experienced DLT.

The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started).

Response Evaluation Criteria in solid tumors (RECIST): Measurable disease is defined as the presence of at least one measurable lesion. Measurable lesions are lesions that can be accurately measured in at least one dimension and fit one of the following criteria:

1. Longest diameter ≥ 20 mm using conventional techniques, or
2. ≥ 10 mm with spiral CT scan.

This is the interval from the initiation of treatment to the time of documented, objective progression using the same methods of evaluation that were used at baseline.

In order for a patient to be regarded as having progressive disease, the following criteria must be met:

1. The site of disease must have been evaluated either at baseline or while receiving study medication. Both evaluations must use the same methodology.
2. PET scan results will not be used as evidence of either progression or response..