A Phase I Trial of the Combination of the PARP Inhibitor ABT-888 With Intraperitoneal Floxuridine (FUDR) in Epithelial Ovarian, Primary Peritoneal and Fallopian Tube Cancers

Inclusion Criteria:

- Histologically confirmed epithelial ovarian, primary peritoneal or fallopian tube
malignancy that is metastatic and for which standard curative measures do not exist

- Disease confined to the intraperitoneal and retroperitoneal cavity; note: nodal
disease below the diaphragm, implants adherent to the surface of the liver or
intrahepatic lesions will not be exclusionary; patients remain eligible if all
intrahepatic tumor is debulked at the time of the intraperitoneal catheter placement

- EXPANSION PHASE ONLY: Evaluable or measurable disease with the largest nodule
measuring less than 5 cm in greatest dimension by radiographic imaging after
debulking procedure

- Candidate for and willingness to have a surgically placed intraperitoneal catheter
and tissue acquisition at the time of port placement; note: if an intraperitoneal
catheter is already in place, a tumor biopsy will still be required; a guided
core-needle biopsy is sufficient in these cases

- Able to swallow and absorb the medication

- Absolute neutrophil count (ANC) >= 1500/mm^3

- Platelets (PLT) >= 100,000/mm^3

- Total bilirubin =< 1.5 x institutional upper limit of normal (ULN)

- Creatinine =< 1.5 x institutional ULN

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) =< 3 x
institutional ULN

- Hemoglobin (Hgb) > 9.0 mg/dl

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2

- Ability to provide informed written consent

- Life expectancy >= 12 weeks

- Women of childbearing potential only: negative pregnancy test done =< 7 days prior to
registration

Exclusion Criteria:

- Known standard therapy for the patient's disease that is potentially curative or
definitely capable of extending life expectancy; note: patients with recurrent
platinum-sensitive ovarian, primary peritoneal or fallopian tube will be allowed, if
the investigator believes the study treatment is a better alternative to initiation
platinum-based chemotherapy, such as patients with a prior platinum allergy or low
volume disease for whom platinum-based therapy is deferred until a later date

- More than 4 prior chemotherapy regimens; note: repeat use of regimens count as 1
prior regimen; switching front-line therapy regimens (for example, from
intraperitoneal to intravenous therapy) for reasons other than progression will count
as 1 prior therapy; bevacizumab and other 'targeted' agents will count in the total
number of prior regimens; vaccine therapies will not count in the total of prior
therapies

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Any of the following prior therapies:

- Chemotherapy =< 28 days prior to registration

- Mitomycin C/nitrosoureas =< 42 days prior to registration

- Immunotherapy =< 28 days prior to registration

- Biologic therapy =< 28 days prior to registration

- Radiation therapy =< 28 days prior to registration

- Investigational therapy or any ancillary therapy considered investigational
(utilized for a non-Food and Drug Administration [FDA] approved indication and
in the context of a research investigation) =< 28 days prior to registration

- Prior poly (ADP-ribose) polymerase (PARP) inhibitor therapy

- Failure to fully recover from acute, reversible effects of prior chemotherapy
regardless of interval since last treatment

- New York Heart Association classification III or IV

- Metastatic disease outside the intraperitoneal cavity and retroperitoneum,
intrahepatic lesions, or pleural effusions; significant ascites precluding catheter
placement; exception: intrahepatic lesions removed or planning to be removed during
the debulking procedure

- Any of the following:

- Nursing women

- Pregnant women

- Women of childbearing potential who are unwilling to employ adequate
contraception (non-barrier method)

- Immunocompromised patients (other than that related to the use of corticosteroids)
with the exception of patients known to be human immunodeficiency virus (HIV)
positive and have a cluster of differentiation 4 (CD4) count > 400 and do not require
antiretroviral therapy

- Receiving any other investigational agent that would be considered a treatment for
the primary neoplasm

- Other active malignancy =< 1 year prior to registration

- EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix

- NOTE: If there is a history or prior malignancy, they must not be receiving
other specific treatment for their cancer

- Significant cardiovascular disease defined as congestive heart failure (New York
Heart Association class II, III or IV), angina pectoris requiring nitrate therapy, or
recent myocardial infarction (=< 6 months prior to registration)