Veliparib and Floxuridine in Treating Patients With Metastatic Epithelial Ovarian, Primary Peritoneal Cavity, or Fallopian Tube Cancer


About this study

This phase I trial studies the side effects and best dose of veliparib when given together with floxuridine in treating patients with metastatic epithelial ovarian, primary peritoneal cavity, or fallopian tube cancer. Veliparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as floxuridine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving veliparib together with floxuridine may kill more tumor cells.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Andrea Wahner Hendrickson, M.D.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Kristina Butler, M.D., M.S.

Closed for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office


More information


Publications are currently not available

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions