Negative urine or serum pregnancy test done =< 7 days prior to registration for females of child bearing potential only Females only:* Urine or serum pregnancy test negative assessed within seven (7) days prior to the start of therapy Non-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 potential Females 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) For females of child-bearing potential, negative serum/urine pregnancy test within 14 days prior to study registration Negative serum pregnancy test obtained for females of child-bearing potential within 28 days prior to step 2 registration For females of child-bearing potential, negative serum or urine pregnancy test within 14 days prior to study registration Women of child-bearing potential must have a negative pregnancy test Female 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 hysterectomy Negative serum pregnancy test result for females of child bearing potential Females of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to start of first cycle of therapy