Abstract 327TiP
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.
Resources from the same session
485P - LDCT lung cancer screening of never-smokers meta-analysis subgroup analysis: Adenocarcinoma is the highly predictive histology identified in never-smokers
Presenter: Sai-Hong Ou
Session: Poster Display
Resources:
Abstract
486P - Fiscal feasibility and implications of integrating lung cancer screening into Hong Kong’s healthcare system
Presenter: Herbert Ho Fung Loong
Session: Poster Display
Resources:
Abstract
487P - Evaluating the performance of the USPSTF lung cancer screening guidelines in an Asian population of lung cancer patients
Presenter: Jian Wei Tan
Session: Poster Display
Resources:
Abstract
488P - Pulmonary ground glass opacity lesions: Immune ecosystem and its clinical relevances of early-stage lung adenocarcinoma
Presenter: Shensi Shen
Session: Poster Display
Resources:
Abstract
489TiP - BGB-LC-202 (NCT05577702): Phase II Umbrella study of tislelizumab (TIS) monotherapy and TIS-based immunotherapy combinations +/- chemotherapy (CT) as neoadjuvant treatment in Chinese patients (pts) with resectable stage II to IIIA non-small cell lung cancer (NSCLC)
Presenter: Wentao Yu
Session: Poster Display
Resources:
Abstract
491P - Furmonertinib as adjuvant therapy for elderly patients in resected EGFR-mutated non-small cell lung cancer: A double-center, real-world experience
Presenter: Ziheng Wu
Session: Poster Display
Resources:
Abstract
492P - Penpulimab-based combination neoadjuvant/adjuvant therapy for patients with resectable locally advanced non-small cell lung cancer: Preliminary results from a phase II study (ALTER-L043)
Presenter: Changli Wang
Session: Poster Display
Resources:
Abstract
493P - The prognostic value of 4L lymph node dissection in left-sided operable non-small cell lung cancer: A systematic review and meta-analysis
Presenter: Lei Peng
Session: Poster Display
Resources:
Abstract
495P - Intrinsic STING of CD8+T cells regulates self-metabolic reprogramming and exerts anti-tumor effects
Presenter: Qiuli Xu
Session: Poster Display
Resources:
Abstract
496P - Fruquintinib plus sintilimab in patients (pts) with advanced non-small cell lung cancer (NSCLC) with PD-L1-positive expression: A multicenter, single-arm phase II study
Presenter: Shun Lu
Session: Poster Display
Resources:
Abstract