Cisplatin and Etoposide With or Without Veliparib in Treating Patients With Extensive Stage Small Cell Lung Cancer

PHASE I

Inclusion Criteria (phase I):

• Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study
• All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
• Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception
• Patients must have histologically or cytologically confirmed:
• Extensive stage small cell lung cancer (SCLC) or
• Stage IV (M1a or M1b according to American Joint Committee on Cancer [AJCC] Staging Manual, 7th edition) large cell neuroendocrine non-small cell lung cancer (NSCLC) or
• Small cell carcinoma of unknown primary or extrapulmonary origin and must be a candidate for systemic therapy
• NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy
• Patients must have measurable or non-measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1; baseline measurements and evaluations of all sites of disease must be obtained = = 1,500/mm^3
• Platelets >= 100,000/mm^3
• Leukocytes >= 3,000/mm^3
• Hemoglobin >= 9 g/dL
• Total bilirubin = = 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x ULN
• Patients with central nervous system (CNS) metastases or a history of CNS metastases are ineligible
• Patients cannot have had prior chemotherapy or biologic therapy for SCLC or large cell neuroendocrine NSCLC, or small cell carcinoma of unknown primary or extrapulmonary origin; patients receiving prior radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to = = 1,500/mm^3
• Platelets >= 100,000/mm^3
• Leukocytes >= 3,000/mm^3
• Hemoglobin >= 9 g/dL
• Total bilirubin = = 60 mL/min/1.73 m^2 for patients with creatinine levels > 1.5 x ULN
• Patients cannot have had prior chemotherapy or biologic therapy for small cell lung cancer; patients receiving prior radiation cannot register within 7 days after completion of radiation, and must have resolved adverse events attributed to radiation to =< grade 1; no previous irradiation to the only site of measurable or evaluable disease, unless that site had subsequent evidence of progression
• Patient must be able to swallow pills
• Patients may not be receiving any other investigational agents while on study

Exclusion Criteria (phase II):

• Patients with CNS metastases or a history of CNS metastases are ineligible
• Patients have history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in the study
• Patients have active seizure(s) or history of seizure(s)
• Patients must NOT have uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, uncontrolled cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• HIV-positive patients on combination antiretroviral therapy are inel