Study of Niraparib With Radiotherapy for Treatment of Metastatic Invasive Carcinoma of the Cervix

Inclusion Criteria

• •1. Participant must have histologically confirmed diagnosis of invasive squamous cell or adenocarcinoma of the cervix, FIGO Stage IIIC2 or IV (see Appendix 5 of the currently approved protocol).
• •2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1.
• •3. Participant must be ≥ 18 years of age.
• •4. Participant must have adequate organ function within 28 days of registration, defined as follows:
• •* Absolute neutrophil count ≥ 1,500/µL
• •* Platelets ≥ 100,000/µL
• •* Hemoglobin ≥ 9 g/dL
• •* Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance ≥ 30 mL/min using the Cockcroft-Gault equation
• •* Total bilirubin ≤ 1.5 x ULN (≤2.0 in patients with known Gilberts syndrome) OR direct bilirubin ≤ 1 x ULN
• •* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x ULN unless liver metastases are present, in which case they must be ≤ 5 x ULN
• •5. Participant receiving corticosteroids may continue as long as their dose is stable for least 4 weeks prior to initiating protocol therapy.
• •6. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
• •7. Female participant of childbearing potential must have a negative serum pregnancy test within 14 days prior to registration. Pregnancy test should be repeated within 7 days before CT simulation if more than 14 days has passed since the previous pregnancy test. (If serum test is falsely positive, pregnancy can be excluded by appropriate pelvic imaging.) Patient must agree to abstain from activities that could result in pregnancy from screening through completion of 7 days of pelvic radiotherapy. Females of non-childbearing potential is defined as follows (by other than medical reasons):
• •* ≥45 years of age and has not had menses for \>1 year
• •* Post-hysterectomy, post-bilateral oophorectomy, post external beam radiation of 6 Gy to the pelvis, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by a physical exam or imaging.
• •8. Participant must agree to not breastfeed during the study and for 180 days after the last dose of study treatment.
• •9. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent
• •10. Participant must have completed 3-6 cycles of platinum based chemotherapy (acceptable regimens in Appendix 7) with clinical evidence of CR (complete response) or PR (partial response) by RECIST criteria no less than 4 weeks and no greater than 12 weeks prior to initiation of protocol therapy. If bevacizumab used, 6 weeks must elapse between administration of bevacizumab and start of radiation therapy.
• •11. Participant must be eligible for chemoradiation treatment in the opinion of the treating investigator.
• •12. Participants who are HIV+ must have CD4 counts \>200/dL and demonstrate documented HAART compliance
• •13. Chemotherapy-related hematological toxicities must have resolved to Grade 1 or less.
• •14. Participant must have had a CT (chest/abdomen/pelvis) or PET-CT, within 56 days of registration