Overview

Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC)

Status:
Not yet recruiting
Trial end date:
2022-01-01
Target enrollment:
0
Participant gender:
Female
Summary
This is a phase II/III randomized controlled trial to evaluate efficacy of platinum-based chemotherapy vs conventionally prescribed non-platinum monochemotherapy in patients with platinum-resistant ovarian cancer
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Criteria
Inclusion Criteria:

- Age 18-70 years;

- Histologically confirmed epithelial ovarian cancer (excluding mucinous, clear-cell and
low-grade subtypes);

- Ovarian cancer recurrence within 3-6 months after completion of platinum-based
chemotherapy (given to possible variability in follow-up practices and tumor growth
kinetics patients with platinum-free interval ≥3 and <7 months will be considered
platinum-resistant);

- Platinum-free interval ≤12 months;

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2;

- Response to penultimate platinum-based chemotherapy defined as partial or complete
response assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1
criteria or ≥50% reduction in CA-125 concentration for patients without measurable
lesions;

- Not refractory to penultimate platinum-based chemotherapy regimen (ie, the disease did
not progress during platinum-based chemotherapy and within ≤3 months after its
completion);

- Patients received ≤3 lines of prior chemotherapy;

- No central nervous system (CNS) metastatic involvement;

- No severe and uncontrolled concomitant diseases;

- Adequate organ function:

- Bone marrow - hemoglobin ≥ 90 g/l; Neutrophils ≥1,5x109/l; Platelets ≥75x109/l);

- Renal - estimated creatinine clearance ≥50 ml/min (determined by Cockcroft-Gault
equation);

- Hepatic - alanine aminotransferase (ALaT) & aspartate transaminase (ASaT) ≤3
upper limit of normal (ULN), total bilirubin ≤ 25 umol/l;

- Known BRCA1/2 mutation status as it will be used for stratification;

- Life expectancy >3 months;

- Patient is willingly consent to participate in the trial and signed informed consent
form

Exclusion Criteria:

- Platinum-refractory ovarian cancer defined as disease progression during penultimate
platinum-based chemotherapy or ≤3 month after its completion;

- No response to penultimate platinum-based chemotherapy;

- Mucinous, clear-cell or low-grade serous/endometrioid histology;

- >3 lines of prior therapy lines for advanced ovarian cancer (prior maintenance
endocrine therapy or poly ADP ribose polymerase (PARP) inhibitors is allowed);

- Prior therapy with PARP-inhibitors and endocrine therapy as a treatment for
progressive ovarian cancer;

- Platinum-free interval >12 months;

- Symptoms of bowel obstruction of any etiology;

- Contraindications to platinum-based chemotherapy;

- Planned administration of PARP inhibitors during or after this line of chemotherapy;

- Life expectancy <3 months;

- Uncontrolled and/or severe concomitant diseases (eg, uncontrolled diabetes mellitus,
renal failure, hepatic failure, uncontrolled arterial hypertension, arrhythmia, heart
failure);

- Metastatic CNS involvement;

- Neuropathy grade >2.