Negative urine or serum pregnancy test done =< 7 days prior to registration for females of child bearing potential onlyXx_NEWLINE_xXFemales only:* Urine or serum pregnancy test negative assessed within seven (7) days prior to the start of therapyXx_NEWLINE_xXNon-pregnant and non-lactating; patients of child-bearing potential must have a negative pregnancy test within 7 days prior to registration; perimenopausal patients must be amenorrheic > 12 months to be considered not of child-bearing potentialXx_NEWLINE_xXFemales of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 50 mIU/mL prior to starting therapy and prior to beginning another cycle (if applicable)Xx_NEWLINE_xXFor females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registrationXx_NEWLINE_xXNegative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registrationXx_NEWLINE_xXFor females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registrationXx_NEWLINE_xXWomen of child-bearing potential must have a negative pregnancy testXx_NEWLINE_xXFemale subjects with child bearing potential must have a negative pregnancy test at screening; child bearing potential is defined as sexually active patients with menses less than 1 year prior to enrollment, < 65 years of age, have no history of oophorectomy or hysterectomyXx_NEWLINE_xXNegative serum pregnancy test result for females of child bearing potentialXx_NEWLINE_xXFemales of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of first cycle of therapyXx_NEWLINE_xX