Status:
UNKNOWN
Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC)
Lead Sponsor:
Blokhin's Russian Cancer Research Center
Conditions:
Ovarian Cancer
Ovarian Neoplasms
Eligibility:
FEMALE
18-70 years
Phase:
PHASE2
PHASE3
Brief 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 ov...
Detailed Description
Recurrent ovarian cancer (ROC) is usually subdivided to platinum-sensitive (platinum-free interval \[PFI\] ≥6 mo.) and platinum-resistant ovarian cancer \[PROC\] (PFI \<6 mo.) subtypes. Prognosis for ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
164 Patients enrolled
Trial Details
Trial ID
NCT04055038
Start Date
September 1 2019
End Date
January 1 2022
Last Update
August 13 2019
Active Locations (1)
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1
N.N. Blokhin Cancer Research Center
Moscow, Russia, 115478