Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Oseltamivir: Tab. Oseltamivir 75 mg PO OD for 12 weeks in combination with Standard of care physicians choice of chemotherapy
Control Intervention1: Standard of care: Physicians choice
Sponsors
All India Institute of Medical Sciences, Delhi
Eligibility
Inclusion criteria
Inclusion criteria: Be willing and able to provide written informed consent for the trial, with a cytopathological or histopathological proven Epithelial Ovarian cancer, have recurrent or metastatic or unresectable disease not amenable to curative intent treatment, Have received and progressed on at least 1 line of anti-cancer treatment in a palliative setting and have either exhausted the standard of care treatment options in second line and beyond, or are unable to afford them, Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2, Demonstrate adequate organ function. In case of reproductive age group females, the last menstrual period is to be documented, and a urine pregnancy test is to be done to rule out pregnancy, if the uterus and ovaries are intact
Exclusion criteria
Exclusion criteria: Patients with more than one active malignancy or a history of other invasive cancer within the last 5 years, Has an active infection requiring systemic therapy, Has a clinically significant co-morbid condition that might preclude a patient from receiving the intervention treatment, including but not limited to significant cardio-vascular disease, such as history of myocardial infarction, acute coronary syndrome or coronary angioplasty, stenting, bypass grafting within the last 6 months. Congestive heart failure, New York Heart Association Class II-IV, or history of CHF, NYHA class III or IV, Respiratory illness like Chronic Obstructive airway disease or Interstitial lung disease , uncontrolled diabetes mellitus, uncontrolled hypertension, residual grade II or more toxicity per National Cancer Institute - Common Terminology Criteria for Adverse Events v6.0, grade II or more peripheral neuropathy from previous treatments, etc., HIV positive patients not on antiretroviral therapy, Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial, Has a known hypersensitivity to the components of the study therapy or its analogues, Is pregnant or lactating, unless willing to go for medical termination of pregnancy and stop lactation respectively.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 12-week Disease Control RateTimepoint: 12-week from the date of randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| 1). Median Progression-free Survival (PFS) End-point Definition: PFS is the time of progression/death from randomization. Outcome measure: Log-rank test will be used to estimate median PFS. 2) Median Overall Survival (OS) End-point definition: OS is the time of death from randomization. Patients will be censored on the data-cut-off date. Outcome measure: Log-rank test will be used to estimate the median OS. 3). Assessment of Toxicities in the intervention arm: Definition & outcome measure: National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events (CTCAE) v6.0 will be used to define & grade the toxicities.Timepoint: median PFS & median OS will be estomated when 50% of enrolled subjects would have progressed/ died respecxtively. Toxicity assessment will continue till 30 days after the last dose of intervention drug administration. | — |
Countries
India
Contacts
Public ContactBabita Kataria
National Cancer Institute campus, All India Institute of Medical Sciences, New Delhi
Outcome results
None listed