ABT-888 and Gemcitabine Hydrochloride in Treating Patients With Advanced Solid Tumors

Inclusion Criteria

• •Histologically confirmed solid tumors meeting 1 of the following criteria:
• •* Progressive disease following standard therapy
• •* Disease for which acceptable standard treatment options do not exist
• •May have received 0-2 prior chemotherapeutic regimens (single-agent or combination chemotherapies)
• •Willing to undergo BRCA mutation analysis
• •* Known BRCA mutations allowed
• •* All patients, at any dose level, without a known BRCA mutation undergo screening with the BRCAPRO program to assess the likelihood of having a BRCA mutation
• •* Patients with a BRCAPRO likelihood of gene mutation of ≥ 20% must undergo BRCA gene testing by the Myriad Genetic Laboratories in order to participate in the study
• •* Patients are eligible whether they have a known deleterious BRCA 1 or 2 mutation or a mutation of uncertain significance
• •No CNS disease (e.g., brain metastases or glioma)
• •No active seizure or history of seizure disorder
• •ECOG performance status 0-2 (Karnofsky 60-100%)
• •Life expectancy \> 3 months
• •ANC ≥ 1,500/mm\^3
• •Platelet count ≥ 100,000/mm\^3
• •Bilirubin \< 2.0 mg/dL
• •AST and ALT \< 3 times upper limit of normal
• •Creatinine normal OR creatinine clearance \> 50 mL/min
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •Able to swallow pills
• •HIV-positive patients allowed provided that CD4 counts are \< 500 and not on protease inhibitors
• •No uncontrolled diarrhea
• •No uncontrolled intercurrent illness including, but not limited to, any of the following:
• •* Ongoing or active infection
• •* Symptomatic congestive heart failure
• •* Unstable angina pectoris
• •* Cardiac arrhythmia
• •* Psychiatric illness or social situations that would limit compliance with study requirements
• •No other concurrent anticancer therapies or agents
• •More than 4 weeks since prior major surgery, radiotherapy, or chemotherapy (6 weeks for mitomycin C or nitrosoureas) and recovered
• •Prior gemcitabine hydrochloride or PARP inhibition therapy, including ABT-888, allowed
• •* No prior combination of gemcitabine hydrochloride and any PARP inhibitor
• •Concurrent bisphosphonate IV allowed provided treatment was initiated before study therapy (for patients with bone metastases or hypercalcemia)
• •Patients with prostate cancer must continue luteinizing-hormone releasing-hormone agonist therapy and discontinue antiandrogens (≥ 6 weeks since bicalutamide and ≥ 4 weeks since flutamide)
• •No other concurrent investigational agents