Health Condition 1: null- Relapsed Epithelial Ovarian Cancer
Conditions
Interventions
Intervention1: Metronomic chemotherapy: Tab. Etoposide 50mg/m2 OD, per orally, Day 1- Day 21
Cyclophosphamide 50mg/m2 OD, per orally, Day 1- Day 21
Tamoxifen 20 mg/m2 BD, per orally, Day 1 â?? Day 28
Sponsors
Tata Memorial Hospital
Eligibility
Inclusion criteria
Inclusion criteria: i. Histologically or cytologically confirmed epithelial ovarian carcinoma. ii. Patients who achieved complete remission with 1st-line treatment and at least partial response after 2nd-line chemotherapy. iii. Patients who have clear disease progression after 2nd CR or PR iv. ECOG performance status 0-2. v. Adequate renal, hepatic and hematopoeitic functions. vi. Baseline CA-125 value >= 40 U/ml, confirmed by repeat testing at baseline (to make it consistent with the definition of serological response by Rustin criteria). vii. Patients who give informed consent to participate in the Study and are willing to comply with the follow-up schedule
Exclusion criteria
Exclusion criteria: i. Any other chemotherapy in the 4 weeks prior to inclusion in this study. ii. Participation in another research protocol at the same time. iii. Patients with evidence of partial or complete intestinal obstruction, who will be unable to comply with an oral chemotherapy protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end-point of the study was serological (CA-125) progression-free survival defined as the date from randomization to the date of first documented serological progression by the Rustin criteria, or the date of death, whichever was earlier.Timepoint: 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 50% serological response rate using CA-125 by the Rustin criteriaTimepoint: 2 years; Progression-free survival defined by the RECIST criteria (date of randomization to first documented progression or death, whichever is earlier). Timepoint: 2 years;Correlation of serological response with inhibition of angiogenesis and induction of apoptosis by the regimen Timepoint: 2 years;Duration of serological response (only in patients who achieve a serological response by the Rustin criteria) defined as the duration in months from first documented serological response to serological progression. Timepoint: 2 years;Evaulation of toxicity by the NCI common toxicity criteriaTimepoint: 2 years;Overall survival â?? date of randomization to deathTimepoint: 2 years;Radiological response using the RECIST criteriaTimepoint: 2 years | — |
Countries
India
Contacts
Public ContactDr Gautam Goyal
Tata Memorial Hospital
Outcome results
None listed