Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Oral Metronomic therapy- OMT
Etoposide, Cyclophosphamide,and Pazopanib: The intervention group will receive 3 drugs OMT:
Tab etoposide (50 mg, day 1 to 10,
Tab cyclophosphamide (50 m
Sponsors
Department of Biotechnology
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed recurrent or metastatic epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer of high-grade serous or endometrioid histology. 2. Patients must have platinum resistant disease (defined as progression within 6 months from completion of a minimum of 4 cycles of platinum containing chemotherapy. 3. Patients must have progressed on or after their most recent line of therapy. Progression must be determined radiographically (RECIST 1.1) and/or CA125 GCIG progression criteria. 4. Participants who had received one line of platinum-based therapy must have received at least four cycles of their initial platinum-containing regimen, had a response (complete or partial), and then had disease progression between 3 and 6 months after their last dose. 5. Patients who have previously received two or three lines of platinum-based therapy must have had disease progression while receiving the therapy or within 6 months after the last dose. Progression will be calculated from the date of the last administered dose of platinum-based therapy to the date of radiographic imaging that shows evidence of progression. Adjuvant Neoadjuvant and maintenance is considered 1 line of therapy, therapy changed due to toxicity in the absence of progression will be considered part of same line, hormonal therapy will be counted as a separate line unless given in maintenance. 6. Patient must have at least one lesion that meets the definition of measurable disease by RECIST 1.1. 7. Age 18 years to 85 years 8. ECOG PS 0 to 2 9. Written informed consent 10. Registered in the Gynecologic Medical Oncology Clinic at AIIMS, New Delhi, or in NCI-AIIMS, Jhajjar
Exclusion criteria
Exclusion criteria: 1. Patients who have refractory disease (progression during the previous platinum-containing therapy) will be ineligible. 2. Patients with clinical symptoms of bowel obstruction. 3. Surgery within 4 weeks before starting study therapy or anticipated need for major surgery during study treatment. 4. Current or recent treatment with another investigational drug within 30 days before the first study dose. 5. Untreated CNS disease or symptomatic CNS metastasis. 6. Serious concurrent illness or clinically relevant active infections. 7. Patients assigned to PLD stratum only. LVEF below the institutional limit of normal as measured by echocardiography. 8. Pregnant or lactating 9. Patients with clear-cell, mucinous or sarcomatous histology, low grade or borderline disease.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| median progression free survivalTimepoint: 3 years | — |
Secondary
| Measure | Time frame |
|---|---|
| median overall survivalTimepoint: median overall survival;overall response rateTimepoint: after 4 months of intervention;quality of lifeTimepoint: At 0,4,6 months | — |
Countries
India
Contacts
Public ContactRaja Pramanik
AIIMS, NEW DELHI
Outcome results
None listed