Clinical Trials

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 (adenosine diphosphate [ADP]-ribose) polymerase (PARP) inhibitor therapy
• Failure to fully recover from acute, reversible effects of prior chemotherapy regardless of interval since last treatment
• Significant cardiovascular disease defined as congestive heart failure (New York Heart Association class III or IV cardiac disease), angina pectoris requiring nitrate therapy or recent myocardial infarction (≤ 6 months prior to registration)
• 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