Randomized Phase II/III Trial to Assess the Efficacy of Platinum-based Chemotherapy vs Standard Non-platinum Therapy in Patients With Platinum-resistant Recurrent Ovarian Cancer (ROC)
| Registry | NCT04055038, acronym EPITOC |
|---|---|
| Status | Unknown |
| Phase | Phase 2 / Phase 3 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 164 (Estimated) |
| Sponsor | Blokhin's Russian Cancer Research Center (Other) |
| Conditions | Ovarian Cancer, Ovarian Neoplasms, Serous Adenocarcinoma, BRCA1 Mutation, BRCA2 Mutation, Chemotherapy |
| Interventions | Platinum-Based Drug, Conventional chemotherapy (Drug) |
| Dates | start 2019-09-01 (estimated), primary completion 2021-09-01 (estimated), completion 2022-01-01 (estimated), first posted 2019-08-13, last updated 2019-08-13 |
| Locations | 1 site in Russia |
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All trials for Ovarian Cancer All trials for Ovarian Neoplasms All trials of Platinum-Based Drug All trials of Conventional chemotherapy
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
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 the latter group is dismal and current guidelines recommend treating these patients with non-platinum based chemotherapy. However, the evidence behind this is quite unconvincing and according to recent data patients with non-platinum refractory platinum-resistant ovarian cancer could derive benefit from platinum rechallenge. This trial is designed for head-to-head comparison of platinum and non-platinum therapy efficacy in treatment of platinum-resistant ovarian cancer.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Platinum-based chemotherapy | Experimental | Drug: Platinum-Based Drug | This is an experimental arm of this study. Allowed therapeutic options: 1. Paclitaxel 60-80 mg/m2 + carboplatin area under curve (AUC) 2-2.7 d 1, 8, 15 every 3 or 4 weeks (Q3W or Q4W); 2. Gemcitabine 1000 mg/m2 d 1, 8 + cisplatin 75 mg/m2 1 every 3 weeks; 3. Doxorubicin 40-50 mg/m2 d 1 + carboplatin AUC5 or cisplatin 60-75 mg/m2 d 1 every 3 weeks; 4. Topotecan 0.75 mg/m2 d 1-3 + cisplatin 60-75 mg/m2 or carboplatin AUC 4-5 d 1 every 3 weeks; 5. Etoposide 100 mg once daily orally d 1-7 + cisplatin 60-75 mg/m2 d1 every 3 weeks. Up to 6 cycles of chemotherapy will be administered to study participants allocated to this arm. |
| Non-platinum monochemotherapy | Active comparator | Drug: Conventional chemotherapy | This is a control arm of this study. Allowed therapeutic options: 1. Paclitaxel 60-80 mg/m2 weekly (or day 1, 8, 15 every 4 weeks schedule); 2. Gemcitabine 1000 mg/m2 d 1, 8, 15 every 4 weeks; 3. Doxorubicin 50-60 mg/m2 d 1 every 3 weeks; 4. Topotecan 1,2-1,5 mg/m2 d 1-5 every 3 weeks; 5. Etoposide 100 mg once daily orally d 1-10 every 3 weeks. Up to 6 cycles of chemotherapy will be administered to study participants allocated to this arm. |
Sex: Female, ages: 18 Years to 70 Years
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.
| Facility | City | Country | Status |
|---|---|---|---|
| N.N. Blokhin Cancer Research Center | Moscow | Russia |