A Limited Access Phase I/II Trial of Paclitaxel, Cisplatin and CTEP Supplied Agent ABT-888 (Veliparib) (IND#77840, NSC#737664) in the Treatment of Advanced, Persistent, or Recurrent Carcinoma of the Cervix

Inclusion Criteria:

- Patients must have primary stage IVB, recurrent, or persistent squamous cell
carcinoma, adenosquamous carcinoma, or adenocarcinoma of the cervix that is not
amenable to curative treatment with surgery and/or radiotherapy

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

- All patients in the phase I portion must have received prior chemoradiation

- Measurable disease not required for patients in the phase I portion

- All patients in the phase II portion 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 dimension to be recorded)

- Each lesion must be ≥ 10 mm when measured by CT scan, 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 scan or MRI

- Patients in the phase II portion 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 radiotherapy

- No patients with history or evidence, upon physical examination, of CNS disease,
including primary brain tumor or brain metastases, within the past 6 months of the
first date of treatment on this study

- GOG performance status 0-2

- ANC ≥ 1,500/mm³

- Platelet count ≥ 100,000/mm³

- Hemoglobin ≥ 9 g/dL

- Creatinine normal OR creatinine clearance ≥ 60 mL/min

- Calcium, magnesium, phosphate, and potassium normal

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST and ALT ≤ 3 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Not pregnant or nursing

- Negative pregnancy test

- Women of child-bearing potential must agree to use adequate contraception (hormonal,
barrier method of birth control, or abstinence) prior to study entry and for the
duration of study participation

- Able to swallow medication

- Free of active infection requiring antibiotics (with the exception of uncomplicated
urinary tract infection [UTI])

- Peripheral neuropathy (sensory and motor) ≤ grade 1

- No history of other invasive malignancies, with the exception of non-melanoma skin
cancer and other specific malignancies, within the past 3 years.

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to veliparib or other agents used in study

- No 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

- No history of cerebrovascular accident (CVA, stroke), transient ischemic attack
(TIA), or subarachnoid hemorrhage within the past 6 months of the first date of
treatment on this study

- No other concurrent investigational agents

- Recovered from effects of recent surgery, radiotherapy, or other therapy

- At least 1 week since prior hormonal therapy directed at the malignant tumor

- Continuation of hormone replacement therapy is permitted

- At least 6 weeks since prior chemoradiotherapy

- At least 3 weeks since prior radiotherapy alone

- At least 6 weeks since prior major surgery

- No prior cancer treatment that contraindicates this protocol therapy

- No prior veliparib or other PARP inhibitors

- No prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for
the treatment of cervical cancer within the last 3 years

- Prior radiotherapy for localized cancer of the breast, head and neck, or skin is
permitted, provided that it was completed more than 3 years prior to
registration and the patient remains free of recurrent or metastatic disease

- No prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment
of cervical cancer within the last 3 years

- Prior adjuvant chemotherapy for localized breast cancer allowed, provided that
it was completed more than 3 years prior to registration and the patient remains
free of recurrent or metastatic disease

- No prior chemotherapy for cervical cancer except when used concurrently with
radiotherapy

- No patients who have received concurrent paclitaxel with radiation therapy