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



Status:Completed
Conditions:Ovarian Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/5/2018
Start Date:April 9, 2012
End Date:January 27, 2018

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A Phase II Evaluation of the Poly (ADP-Ribose) Polymerase (PARP)-1 and -2 Inhibitor Veliparib (ABT-888) (NSC#737664) in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Who Carry a Germline BRCA1 or BRCA2 Mutation

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.

PRIMARY OBJECTIVES:

I. To estimate the proportion of patients who have objective tumor response (complete or
partial).

II. To determine the frequency and severity of adverse events associated with treatment with
veliparib (ABT-888) as assessed by the Active Version of the National Cancer Institute (NCI)
Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival (PFS) and overall survival (OS).

II. To determine the proportion of patients who survive progression-free for at least 6
months.

TERTIARY OBJECTIVES:

I. To explore the association between single nucleotide polymorphisms (SNPs) in
deoxyribonucleic acid (DNA) repair genes (e.g., breast cancer [BRCA]1, Fanconi) and clinical
characteristics, response, and patient outcome (PFS and OS).

OUTLINE:

Patients receive veliparib orally (PO) twice daily (BID) on days 1-28. Courses repeat every
28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

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
We found this trial at
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Bremerton, Washington 98310
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