Trial Search Results

Veliparib in Treating Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

National Cancer Institute (NCI)

Intervention(s):

  • Other: Laboratory Biomarker Analysis
  • Drug: Veliparib

Phase:

Phase 2

Eligibility


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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061
Not Recruiting