327TiP - A single arm phase II study of single agent pemetrexed in platinum resistant/refractory epithelial ovarian or primary peritoneal cancer

Background

Management of platinum resistant ovarian cancer has always been challenging for oncologists. Best option in this setting is single agent chemotherapy with bevacizumab. However, due to various contraindications and financial constraints, many of them do not receive bevacizumab. Due to high expression of folate receptor alpha in high grade epithelial ovarian cancers pemetrexed could be a potential treatment option. To our knowledge there are only 2 phase II trials across the globe showing the effectiveness of pemetrexed in platinum resistant/refractory ovarian cancer and till date there is no prospective data in Indian patients with platinum resistant/refractory ovarian cancer.

Trial design

The study is a single centre, investigator-initiated, single arm phase II clinical trial designed using Simon two stage optimal design. Eligible patients are adults (age ≥18 years), with histologically confirmed high grade epithelial ovarian or primary peritoneal cancer, who have relapsed within 6 months of platinum-based chemotherapy, who are bevacizumab ineligible, with ECOG performance status of 0-2, adequate organ function, with either measurable disease with at least one target lesion for response evaluation as per RECIST 1.1 criteria or non-measurable disease with CA-125 level ≥2 times ULN measured at least 2 weeks before enrolment. Estimated sample size is 63. At least 2 out of 22 responses in stage I are expected in order to proceed to stage II and further recruitment of the patients. Baseline contrast enhanced CT scan of chest, abdomen and pelvis along with CA-125 level will be recorded. Eligible patients will receive Pemetrexed at dose of 500 mg/m² every 21 days. Response assessment will be done after 3 cycles of chemotherapy (RECIST 1.1 will be used for measurable disease and GCIG criteria using CA-125 level will be used for non-measurable disease) and subsequent responses will be assessed every 12-16 weeks. Treatment will continue until progression, intolerable toxicity or death. Primary objective is Objective Response Rate (ORR). Secondary objectives are Progression Free survival (PFS), Overall Survival (OS), Clinical Benefit Rate (CBR), Toxicity profile and Quality of Life (QoL).

Clinical trial identification

CTRI/2022/08/044939.

Legal entity responsible for the study

The authors.

Funding

Has not received any funding.

Disclosure

All authors have declared no conflicts of interest.