Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer (NCT04377087) | Clinical Trial Compass
TerminatedPhase 2
Delayed Initiation of Olaparib Maintenance Therapy in Platinum Sensitive Recurrent Ovarian Cancer
Stopped: Slow enrollment
United States3 participantsStarted 2020-06-29
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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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 …