Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Losartan Drug: Tab. Losartan 25mg OD orally for 2 weeks along with Tab. Cyclophosphamide Chemotherpay 50mg OD orally for 21 days On and 7 Days off.
If 25 mg of Losartan tolerated well
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age 18yrs or older Females. 2.Patient who has signed Informed consent forms. 3.Recurrent platinum resistant/refractory epithelial ovarian cancer (at-least one line of treatment should be received, including prior bevacizumab allowed). 4.Patient has an ECOG performance status of 0, 1, 2. 5.Patient has adequate bone marrow; hepatic, renal functions as below: Screening Laboratory Values should be within the following limits: a) Absolute Neutrophil Count should be greater than or equal to 1500 per cubic millimeter b) Platelet Count should be greater than or equal to 100000 per cubic millimeter c) Hemoglobin should be greater than or equal to 9 grams per deciliter d) Creatinine should be less than or equal to 1.5 times the upper limit of normal e) Serum Bilirubin should be less than or equal to 1.5 times the upper limit of normal f) Aspartate Aminotransferase and/or Alanine Aminotransferase should be less than 2 times the upper limit of normal
Exclusion criteria
Exclusion criteria: 1.Patient has not recovered to Grade two or to baseline from adverse events caused by prior chemotherapy. 2.Patient has symptomatic and uncontrolled brain or leptomeningeal metastases. 3.Patient is considered to be at poor medical risk due to a serious and uncontrolled medical disorder, a nonmalignant systemic disease, or an active and uncontrolled infection. 4.Patient has a bowel obstruction that is related to the underlying disease. 5.Known hypertensive on Losartan: Patients who have taken losartan as an antihypertensive medication within six months prior to enrollment in the study will be excluded
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the progression free survival (PFS).Timepoint: Disease Assessment will be done at Basline, Week 1, Week 2, Week 4 and then at every 4 weeks until disease progression or any toxicity. | — |
Secondary
| Measure | Time frame |
|---|---|
| a.Overall Survival b.Decrease in Ascites /clinical benefit c.Disease control ratesTimepoint: Assessment will be done at every 4 weeks till the disease progression. | — |
Countries
India
Contacts
Public ContactDr Sushmita Rath
Tata Memorial Hospital
Outcome results
None listed