Delayed Initiation of Olaparib Maintenance Therapy for the Treatment of Platinum Sensitive Recurrent Ovarian Cancer

Status: administratively complete

This phase IIA trial investigates 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 patients with platinum sensitive ovarian cancer that has come back (recurrent). PARPs are proteins that help repair DNA mutations. PARP inhibitors, such as olaparib, can keep PARP from working, so tumor cells can't repair themselves, and they may stop growing. This trial also investigates how delaying the start of olaparib affects symptoms, physical functioning, quality of life, and impact on finances.

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 partial response (PR) or complete response (CR) as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 or a CA-125 response, according to Gynecological Cancer InterGroup (GCIG) criteria
BRCA testing required (results not needed for registration)
Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
Life expectancy greater than 6 months
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Platelets >= 100 x 10^9/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 upper limit of normal (ULN)
Aspartate aminotransferase (AST) and alanine aminotransferase (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

PRIMARY OBJECTIVE:

I. To determine the time to first subsequent therapy.

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) for delayed start olaparib in platinum sensitive recurrent epithelial ovarian cancer with a complete or partial response to last platinum therapy.

II. To estimate the overall survival (OS) for delayed start olaparib in platinum sensitive recurrent epithelial ovarian cancer with a complete or partial response to last platinum therapy.

III. To determine the safety and tolerability for delayed start olaparib in platinum sensitive recurrent epithelial ovarian cancer with a complete or partial response to last platinum therapy.

IV. To determine the overall response rate of delayed start olaparib in platinum sensitive recurrent epithelial ovarian cancer with a partial response or complete response to last platinum therapy stratified by BRCA mutational status.

V. To evaluate the impact of delayed start olaparib in platinum sensitive recurrent epithelial ovarian cancer with a complete or partial response to last platinum therapy on patient reported adverse events.

VI. To evaluate the impact of delayed start olaparib in platinum sensitive recurrent epithelial ovarian cancer with a complete or partial response to last platinum therapy on quality of life.

VII. To evaluate the impact of delayed start olaparib in platinum sensitive recurrent epithelial ovarian cancer with a complete or partial response to last platinum therapy on physical functioning.

VIII. To evaluate the impact of delayed start olaparib in platinum sensitive recurrent epithelial ovarian cancer with a complete or partial response to last platinum therapy on worry and distress.

IX. To evaluate the impact of delayed start olaparib in platinum sensitive recurrent epithelial ovarian cancer with a complete or partial response to last platinum therapy on financial toxicity.

X. To explore exposure-response relationships between olaparib exposure and toxicity/efficacy.

EXPLORATORY OBJECTIVES:

I. To evaluate PARP inhibitor resistance mechanisms.

Ia. Characterize genomic changes associated with olaparib resistance.

Ib. Characterize transcriptome changes associated with olaparib resistance.

OUTLINE:

At first evidence of a two-fold rise in CA-125 from baseline, patients receive olaparib orally (PO) twice daily (BID) on days 1-28. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, then every 3 months for up to 18 months.

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Delayed Initiation of Olaparib Maintenance Therapy for the Treatment of Platinum Sensitive Recurrent Ovarian Cancer

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