Ovarian CancerPhase 2/3EPITOCNCT04055038
Efficacy of Platinum-based Chemotherapy in Platinum-resistant Ovarian Cancer) (EPITOC)
A Phase 2/3 study testing Platinum-Based Drug and Conventional chemotherapy in people with Ovarian Cancer and Ovarian Neoplasms, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Ovarian Cancer, Ovarian Neoplasms, Serous Adenocarcinoma
- What is being tested?
- Platinum-Based Drug and Conventional chemotherapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteRussia
- Study dates
- 1 Sep 2019to 1 Jan 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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)
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
Read the 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 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.
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Serous Adenocarcinoma, BRCA1 Mutation, BRCA2 Mutation, Chemotherapy
- Being tested
- Platinum-Based Drug, Conventional chemotherapy
- Medical subject headings
- Ovarian Neoplasms, Cystadenocarcinoma, Serous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platinum-Based DrugDrug
Reintroduction of platinum-based chemotherapy
Conventional chemotherapyDrug
Conventional chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Platinum-based chemotherapy | Experimental | 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. Receives: Drug: Platinum-Based Drug |
| Non-platinum monochemotherapy | Active comparator | 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. Receives: Drug: Conventional chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective response rate (RR) according to RECIST 1.1 criteria
Primary outcome for Phase II part: response rate to treatment according to RECIST1.1 criteria. For patients without measurable disease Rustin criteria is allowed.
Measured: 0-18 weeks
Overall survival defined as time from randomization to death from any reason;
Primary outcome for Phase III part: 2. Overall survival defined as time from randomization to death from any reason
Measured: 1 year
Secondary outcomes (4)
Progression-free survival
Progression-free survival (PFS) defined as time from randomization to disease progression according to RECIST 1.1 criteria or death from any reason;
Measured: 12 months
Overall survival
Overall survival defined as time from randomization to death from any reason (for Phase II part only);
Measured: 12 months
Progression-free survival 2 (PFS2)
PFS2 defined as time from randomization to second disease progression event according to RECIST 1.1 criteria or death from any reason;
Measured: 24 months
Objective response rate (RR) according to RECIST 1.1 criteria
Response rate to treatment according to RECIST1.1 criteria. For patients without measurable disease Rustin criteria is allowed (only for Phase II part).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Sep 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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)
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blokhin's Russian Cancer Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04055038
- Sponsor's protocol ID
- PROC2019
- Acronym
- EPITOC
- Status last verified
- Aug 2019
- First submitted
- 28 Apr 2019
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT04055038
- Acronym / sponsor ID
- EPITOC / PROC2019
- Conditions
- Ovarian Cancer, Ovarian Neoplasms, Serous Adenocarcinoma, BRCA1 Mutation, BRCA2 Mutation, Chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Blokhin's Russian Cancer Research CenterUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Sep 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 13 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Platinum-based chemotherapy | Experimental | Drug: Platinum-Based DrugThis 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 chemotherapyThis 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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;
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Platinum-Based DrugReintroduction of platinum-based chemotherapy | Drug | Platinum-based chemotherapy |
| Conventional chemotherapyConventional chemotherapy | Drug | Non-platinum monochemotherapy |
Primary outcome
Objective response rate (RR) according to RECIST 1.1 criteria
Time frame: 0-18 weeks
Primary outcome for Phase II part: response rate to treatment according to RECIST1.1 criteria. For patients without measurable disease Rustin criteria is allowed.
Overall survival defined as time from randomization to death from any reason;
Time frame: 1 year
Primary outcome for Phase III part: 2. Overall survival defined as time from randomization to death from any reason
4 secondary outcomes
Progression-free survival
Time frame: 12 months
Overall survival
Time frame: 12 months
Progression-free survival 2 (PFS2)
Time frame: 24 months
Objective response rate (RR) according to RECIST 1.1 criteria
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Platinum-Based Drug and Conventional chemotherapy in people with Ovarian Cancer and Ovarian Neoplasms, run by Blokhin's Russian Cancer Research Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexey Rumyantsev, MD (+79100022255, alexeymma@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate (RR) according to RECIST 1.1 criteria (time frame: 0-18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2019.