• Subject decides to withdraw from the study therapy . (In this event, the reasons for withdrawal will be documented .) • Positive pregnancy test 3.4.2 Off-S tudy Criteria Subjects will be removed from study for any one of the following criteria: • Participant requests to be withdrawn from study; in this event, the reasons for withdrawal will be documented. • A patient who is noncompliant with protocol guidelines may be removed from the study at the discretion of the principal investigator. • Disease progression, defined by irRC in Appendix B (Section 13.2). • Death . 3.4.3 Off-Study Procedure Authorized staff must notify Central R egistration Office (CRO) when a subject is taken off - study. An off-study form from the web site (http://home.ccr.cancer.gov/intra/eligibility/welcome.htm ) main page must be completed and sent via encrypted email to: NCI Central Registration Office (HOIS) ncicentralregistration - l@mail.nih.gov . 4 CONCOMITANT MEDICATIONS/MEASURES Anti-emetics and antidiarrheal agents may be admi nistered as required, but are not anticipated to be needed and should not be used prophylactically.