Ovarian Cancer
Conditions
Keywords
Cancer, ovary, PARP inhibitors, toxicity, elder patients
Brief summary
Poly(ADP-ribose) polymerase (PARP) inhibitors are anti-cancer treatments that induce preferential tumor cell death. Their efficacy has been demonstrated in many tumor models, primarily in advanced ovarian cancer. PARP inhibitors also exhibit a particular toxicity, damaging the hematopoietic tissue. With age, pharmacokinetic changes or a reduction in medullary cavity may increase these toxicities and may lead to dose reductions/postponements or premature discontinuation of PARP inhibitors, which may impact the efficacy of treatment. Close biological monitoring must be carried out to limit these toxicities, in most cases anemia, thrombocytopenia and neutropenia. Until now, the geriatric factors impacting the tolerance and uptake of PARP inhibitors in the elderly patient population with advanced ovarian cancer are not clearly established. It is therefore necessary to have prospective real-life data in order to support patients in a decision-making process on whether or not to continue such treatments. PARIB-OLD-PRO² will evaluate the association between various clinical, biological, and geriatric factors and the relative dose intensity (RDI) of therapy by PARP inhibitors. This is a prospective, multicenter longitudinal and non-interventional study and will involve a population of 50 patients, aged 70 years and elder, with advanced ovarian cancer who are scheduled to start a therapy with PARP inhibitors for the first time. The aim of the study is to better understand the effects of PARP inhibitors on a elderly population, knowledge of the genetic and clinical determinants of PARP inhibitors toxicity in this specific population and an optimal management of this therapy related adverse events in order to maintain an RDI.
Interventions
OTHERQoL surveys
2 quality of life surveys (OV28 and ELD14) will be completed by patients every 3 months during a 12-month period
OTHERGeriatric assessment (G-CODE)
A geriatric assessment (G-CODE) will be performed by the research staff every 3 months during a 12-month period
BIOLOGICALBlood sampling
A supplementary volume of blood will be collected from a routine blood sample (8 mL) at 3 different time points : one at inclusion, one 6 and 12 months after the beginning of PARP inhibitors treatment. Genetic lab test will be performed to assess whether there is a specific genetic signature for PARP inhibitors toxicity.
Sponsors
Hospices Civils de Lyon
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
70 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 70 years * Histologically or cytologically confirmed diagnosis of advanced ovarian cancer (FIGO stage III or IV) * PARP inhibitors -naive patient who need to initiate maintenance treatment with PARP inhibitors for the first time (according the the marketing authorization) * Patient with a life expectancy of more then 3 months * Informed patient which does not oppose to participate to the study
Exclusion criteria
* Prior treatment with PARP inhibitors * Patient incapable to take oral tablets/capsules * Participation in a drug trial that does not authorize concurrent participation in another trials * Person unable to attend scheduled examinations/appointments as part of routine care for geographical, social or psychological reasons * Concomitant cancer or f cancer history (other than those included in the inclusion criteria) treated and considered cured for less than 2 years. However, patients with the following pathologies are eligible: * Basal cell carcinoma or non-invasive cutaneous squamous cell carcinoma * Stage 1B or less cervical carcinoma * Non-invasive superficial bladder cancer
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative dose intensity of the PARP inhibitors treatment | at 12 months | Ratio of the delivered PARP inhibitors dose intensity to the planned dose intensity at the beginning of the treatment |
Countries
France
Contacts
CONTACTClaire FALANDRY, Professor
CONTACTGabriel ANTHERIEU, MD, PhD
PRINCIPAL_INVESTIGATORClaire FALANDRY, Professor
Hospices Civils de Lyon
Outcome results
None listed