Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Condition: BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Ovarian Epithelial Tumor; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma
MeSH terms: Carcinoma; Recurrence
Intervention: Laboratory Biomarker Analysis; Veliparib
Intervention description: Correlative studies; Given PO
Intervention MeSH terms: Veliparib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well veliparib works in treating patients with epithelial
      ovarian, fallopian tube, or primary peritoneal cancer that has come back or does not respond
      to treatment. Veliparib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have recurrent or persistent epithelial ovarian, fallopian tube, or
             primary peritoneal carcinoma AND carry a germline mutation in BRCA1 or BRCA2
             (confirmation required via Myriad test report); histologic documentation of the
             original primary tumor is required via the pathology report

          -  All patients must have measurable disease as defined by Response Evaluation Criteria
             in Solid Tumors(RECIST)1.1; measurable disease is defined as at least one lesion that
             can be accurately measured in at least one dimension (longest diameter to be
             recorded); each lesion must be >= 10 mm when measured by computed tomography (CT),
             magnetic resonance imaging (MRI), or caliper measurement by clinical exam; or >= 20 mm
             when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured
             by CT or MRI

          -  Patient must have at least one "target lesion" to be used to assess response on this
             protocol as defined by RECIST; tumors within a previously irradiated field will be
             designated as "non-target" lesions unless progression is documented or a biopsy is
             obtained to confirm persistence at least 90 days following completion of radiation
             therapy

          -  Patients who have received one prior cytotoxic regimen must have a Gynecological
             Oncology Group (GOG) performance status of 0, 1, or 2

          -  Patients who have received two or three prior cytotoxic regimens must have a GOG
             performance status of 0 or 1

          -  Recovery from effects of recent surgery, radiotherapy, or chemotherapy

               -  Patients should be free of active infection requiring antibiotics (with the
                  exception of uncomplicated urinary tract infection [UTI])

               -  Any hormonal therapy directed at the malignant tumor must be discontinued at
                  least one week prior to registration; continuation of hormone replacement therapy
                  is permitted

               -  Any other prior therapy directed at the malignant tumor, including chemotherapy,
                  biologic/targeted (non-cytotoxic) agents and immunologic agents, must be
                  discontinued at least three weeks prior to registration; patients receiving
                  nitrosoureas or mitomycin C must discontinue 6 weeks prior to registration

               -  Any prior radiation therapy must be discontinued at least four weeks prior to
                  registration

          -  Prior therapy

               -  Patients must have had one prior platinum-based chemotherapeutic regimen for
                  management of primary disease containing carboplatin, cisplatin, or another
                  organoplatinum compound; this initial treatment may have included intraperitoneal
                  therapy, consolidation, biologic/targeted (non-cytotoxic) agents or extended
                  therapy administered after surgical or non-surgical assessment

               -  Patients are allowed to receive, but are not required to receive, two additional
                  cytotoxic regimens for management of recurrent or persistent disease

               -  Patients are allowed to receive, but are not required to receive,
                  biologic/targeted (non-cytotoxic) therapy for management of recurrent or
                  persistent disease; patients are allowed to receive, but are not required to
                  receive, biologic/targeted (non-cytotoxic) therapy as part of their primary
                  treatment regimen

               -  Patients with both platinum-sensitive and platinum-resistant disease are
                  eligible; patients with platinum-refractory disease are NOT eligible

               -  Definitions:

                    -  Platinum sensitive ovarian cancer is defined as patients who respond to
                       platinum-based therapy (complete or partial) and then progress/recur more
                       than 6 months after their last platinum dose (i.e., platinum-free interval
                       is > 6 months)

                    -  Platinum resistant ovarian cancer is defined as patients who respond to
                       platinum-based therapy (complete or partial) and then progress/recur within
                       6 months of their last platinum dose (i.e., platinum-free interval is =< 6
                       months)

                    -  Platinum refractory ovarian cancer is defined as patients who have
                       progression of disease while receiving platinum-based chemotherapy or who
                       fail to achieve at least a partial response to platinum-based chemotherapy
                       (i.e., best response to platinum-based chemotherapy is stable disease)

          -  Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

          -  Platelets greater than or equal to 100,000/mcl

          -  Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)

          -  Bilirubin less than or equal to 1.5 x ULN

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) less than or equal
             to 3 x ULN

          -  Alkaline phosphatase less than or equal to 2.5 x ULN

          -  Patients must have signed an approved informed consent and authorization permitting
             release of personal health information

          -  Patients of childbearing potential must have a negative pregnancy test prior to the
             study entry and be practicing an effective form of contraception

        Exclusion Criteria:

          -  Patients who have had previous treatment with veliparib (ABT-888) or any other poly
             (adenosine diphosphate [ADP]-ribose) polymerase 1 (PARP) inhibitor (including
             olaparib); note: Iniparib (BSI-201) cannot inhibit PARP1 at pharmacologically
             achievable concentrations, therefore prior iniparib therapy is allowed

          -  Patients with a history of other invasive malignancies, with the exception of
             non-melanoma skin cancer and other specific malignancies, are excluded if there is any
             evidence of other malignancy being present within the last three years; patients are
             also excluded if their previous cancer treatment contraindicates this protocol therapy

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis OTHER THAN for the treatment of ovarian, fallopian tube, or primary
             peritoneal cancer within the last three years are excluded; prior radiation for
             localized cancer of the breast, head and neck, or skin is permitted, provided that it
             was completed more than three years prior to registration, and the patient remains
             free of recurrent or metastatic disease

          -  Patients who have received prior chemotherapy for any abdominal or pelvic tumor OTHER
             THAN for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within
             the last three years are excluded; patients may have received prior adjuvant
             chemotherapy for localized breast cancer, provided that it was completed more than
             three years prior to registration, and that the patient remains free of recurrent or
             metastatic disease

          -  Patients with seizures or history or seizures are ineligible

          -  Patients with history or evidence upon physical examination of central nervous system
             (CNS) disease, including primary brain tumor, any CNS metastases, or history of
             cerebrovascular accident (CVA, stroke), transient ischemic attack (TIA) or
             subarachnoid hemorrhage within six months of the first date of treatment on this study
             are ineligible; patients with CNS metastases must be stable for > 3 months after
             treatment and off steroid treatment prior to study enrollment

          -  Inability or unwillingness to swallow pills

          -  Patients with clinical symptoms or signs of gastrointestinal obstruction and/or who
             require parenteral hydration or nutrition

          -  Patients who are pregnant or nursing