A Phase II Evaluation of ABT-888 (IND# 77840, NCI Supplied Agent: ABT-888, NSC #737664), Topotecan (NSC #609699) and Filgrastim or Pegfilgrastim in the Treatment of Persistent or Recurrent Squamous or Non-Squamous Cell Carcinoma of the Cervix

Inclusion Criteria:

- Patients must have persistent or recurrent squamous cell carcinoma, adenosquamous
carcinoma, adenocarcinoma, or non-squamous cell carcinoma of the cervix with
documented disease progression

- Histological documentation of the original primary tumor is required via the
pathology report

- All patients must have measurable disease as defined by 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 CT, 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 1.1

- 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 must not be eligible for a higher priority GOG protocol, if one exists

- In general, this would refer to any active GOG phase III protocol or rare tumor
protocol for the same patient population

- Patients MUST have had one prior systemic chemotherapeutic regimen for management of
advanced, metastatic, or recurrent squamous cell or non-squamous cell carcinoma of
the cervix

- Chemotherapy administered in conjunction with primary radiation as a radiation
sensitizer is not counted as a systemic chemotherapy regimen

- Patients are required to have prior pelvic radiation (for patients who are registered
during the safety lead-in portion of this protocol)

- Patients MUST not be eligible for further curative intent surgical or pelvic
radiation treatment for management of recurrent or persistent disease as determined
by treating physicians

- Patients must have a GOG performance status of 0, 1, or 2

- 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 of normal (ULN)

- Bilirubin less than or equal to 1.5 x ULN

- SGOT (AST) less than or equal to 3 x ULN

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use adequate contraception (hormonal or barrier method of birth
control; abstinence) prior to study entry and for the duration of study participation

- Patients must have the ability to swallow pills whole

- Patients should be free of active infection requiring antibiotics

- Neuropathy (sensory and motor) less than or equal to grade 1

- Patients with 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 excluded

- Patients may NOT receive amifostine or other protective agents

- Patients must have NOT received more than one previous cytotoxic chemotherapy regimen
(either with single or combination cytotoxic drug therapy)

- Patients are allowed to have received, but are not required to have received, one
additional non-cytotoxic regimen for management of recurrent or persistent disease
according to the following definition:

- Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to)
monoclonal antibodies, cytokines, and small-molecule inhibitors of signal
transduction

- Recovered from effects of recent surgery, radiotherapy, or chemotherapy

- 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 biological and
immunologic agents, must be discontinued at least three weeks prior to registration

- All side effects must have resolved to ≤ grade 1 or stabilized, prior to
enrolling on this study

Exclusion Criteria:

- Patients are excluded who have had prior therapy with ABT-888 (veliparib), poly
(ADP)-ribose polymerase inhibitors, or topotecan

- Patient 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 cervical 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 cervical cancer within the last three years are excluded

- Patients may have received prior adjuvant chemotherapy for 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 of seizures are ineligible

- Patients with history or evidence upon physical examination of 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
excluded; patients with CNS metastases must be stable for > 3 months after
treatment and off steroid treatment prior to study enrollment