Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer

• Status: Recruiting
• Trial end date: 2024-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to test if delaying the start of the olaparib until there is a rise in a tumor marker called CA-125 will result in a longer time until the next or different treatment for the patient's cancer. The study will also evaluate how delaying the start of maintenance therapy will affect symptoms; physical functioning; quality of life; and impact on finances.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sarah E Taylor
• Collaborator: American Society of Clinical Oncology
• Treatments: Olaparib

Criteria

Inclusion Criteria:

• Patient has platinum-sensitive, recurrent ovarian, fallopian-tube or peritoneal cancer. Platinum sensitivity is defined as complete clinical remission after frontline chemotherapy lasting greater than 6 months

• Patient has completed at least 2 courses of platinum-based chemotherapy with a PR or CR as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.139 or a CA-125 response, according to Gynecological Cancer InterGroup (GCIG) criteria40

• BRCA testing required (results not needed for registration)

• ECOG performance status score of 0, 1, or 2 (See Appendix A)

• Life expectancy greater than 6 months

• Normal organ and marrow function as defined: Absolute neutrophil count (ANC) ≥ 1.5 x 109/L; Platelets ≥ 100 x 109/L; Hemoglobin (Hgb) ≥ 8 g/dL (blood transfusions to reach this amount are allowed); Serum creatinine ≤ 1.5 mg/dL; Total serum bilirubin ≤ 1.5 x ULN; AST and ALT ≤ 2.5 x ULN

• Able to take oral medication

• Not pregnant and not breastfeeding

• Able to understand and willingness to sign a written informed consent document

• Patients must be enrolled within 8 weeks of completing last cycle of chemotherapy

Exclusion Criteria:

• Patient has had a prior invasive malignancy diagnosed within the last five years (except [1] non-melanoma skin cancer or [2] prior in situ carcinoma of the cervix or breast [3] has been without evidence of invasive disease for greater than 3 years)

• Patients receiving any other investigational agents

• History of allergic reactions attributed to compounds of similar chemical or biologic composition to olaparib

• Uncontrolled intercurrent illness that could affect their participation in the study including, but not limited to, ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; known inadequately controlled hypertension; significant pulmonary disease including dyspnea at rest, patients requiring supplemental oxygen, or poor pulmonary reserve; or psychiatric illness/social situations that would limit compliance with study requirements

• Impairment of gastrointestinal function or disease that may significantly alter the absorption of olaparib

• Patients who have received prior treatment with a PARP inhibitor

• History of noncompliance to medical regimens