Health Condition 1: C569- Malignant neoplasm of unspecifiedovary
Conditions
Interventions
Intervention1: Pemetrexed injection every 3 weeks: Pemetrexed 500 mg/m2 IV infusion in 100 mL NS over 10 minutes.
The cycle will be repeated every 21 days.
Pre-medications: Dexamethasone 4 mg BD x 3
Sponsors
Dr BRA IRCH AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1. Histologically confirmed recurrent or metastatic epithelial ovarian cancer or primary peritoneal cancer of high grade serous or endometrioid histology. 2. One or more prior lines of therapy with at least one platinum based chemotherapeutic regimen, containing carboplatin or cisplatin. 3. Bevacizumab ineligible patients ââ?¬â?? either not affordable for bevacizumab or contraindication for use of bevacizumab or use of bevacizumab in past 6 months. 4. Disease must be platinum refractory (progression during platinum based therapy) or platinum resistant (treatment free interval after platinum based therapy of less than 6 months) 5. Age > 18 years 6. ECOG PS 0-2 7. Measurable disease with at least one target lesion which could be used for response evaluation as per RECIST 1.1 criteria or non-measurable disease (as defined by RECIST) with CA-125 level ââ?°Â¥2 times ULN at least 2 weeks before enrolment. 8. Adequate organ function: Bone marrow function: Hb more than 8g/dL, WBC count more than 3000/mm3, granulocytes more than 1500/mm3 and platelets more than 100000/mm3 9. LFT: S. bilirubin less than 1.5 times institutional norm, AST/ALT/ALP less than 3 times ULN 10. RFT: S. creatinine less than 2 mg/dL, eGFR more than 45mL/min 11. Written informed consent
Exclusion criteria
Exclusion criteria: 1. Patient with another malignancy before entering the study or a concomitant malignancy 2. Clear cell or mucinous histology 3. Recent surgery, radiation therapy or chemotherapy directed at the malignant tumor within 3 weeks prior to enrolment 4. Uncontrolled severe comorbidities 5. Pregnancy or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the Objective Response Rate [ORR; Complete Response (CR) plus Partial Response (PR)]Timepoint: After 3 cycles (after 9 weeks) and subsequently every 12-16 weeks or earlier if clinical suspicion of progression | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the Progression Free Survival (PFS) and Overall Survival (OS) Clinical Benefit Rate [CBR; CR plus PR plus stable disease (SD)] Evaluate the change in Quality of Life (QOL) at different time points To assess toxicity profile Timepoint: Progression free survival (PFS) will be assessed after confirmation of progression or death Overall survival (OS) will be assessed after death due to any cause Quality of Life (QoL) will be assessed at baseline and subsequently after every cycle (every 3 weeks) Toxicity profile will be assessed after every cycle (every 3 weeks) | — |
Countries
India
Contacts
Public ContactSwasthik Upadhya P
Dr. BRA IRCH, AIIMS, New Delhi
Outcome results
None listed