Status:
TERMINATED
Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer
Lead Sponsor:
Sarah E Taylor
Collaborating Sponsors:
American Society of Clinical Oncology
Conditions:
Ovarian Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
This is a Phase II trial will investigate if waiting until the time of chemical recurrence, denoted by rising CA125, to start a PARP inhibitor will lead to an improved time to next therapy with improv...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04377087
Start Date
June 29 2020
End Date
May 31 2023
Last Update
August 20 2024
Active Locations (1)
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1
Magee Women's Hospital of UPMC
Pittsburgh, Pennsylvania, United States, 15213