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

Ovarian Cancer Clinical Trial

— EPITOC  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04055038
• Other study ID #: PROC2019
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: September 1, 2019
• Est. completion date: January 1, 2022

Study information

• Verified date: August 2019
• Source: Blokhin's Russian Cancer Research Center
• Contact: Alexey Rumyantsev, MD
• Phone: +79100022255
• Email: alexeymma[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 164
• Est. completion date: January 1, 2022
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adenocarcinoma
• BRCA1 Mutation
• BRCA2 Mutation
• Carcinoma, Ovarian Epithelial
• Chemotherapy
• Ovarian Cancer
• Ovarian Neoplasms
• Serous Adenocarcinoma

Intervention

Drug:
• Platinum-Based Drug
Reintroduction of platinum-based chemotherapy
• Conventional chemotherapy
Conventional chemotherapy

Locations

Country	Name	City	State
Russian Federation	N.N. Blokhin Cancer Research Center	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Blokhin's Russian Cancer Research Center

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	0-18 weeks
Primary	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	1 year
Secondary	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;	12 months
Secondary	Overall survival	Overall survival defined as time from randomization to death from any reason (for Phase II part only);	12 months
Secondary	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;	24 months
Secondary	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).	12 months