Predictive factors and pharmacokinetics of intraperitonal chemotherapy

Predictive factors and pharmacokinetics of intraperitonal chemotherapy - IP chemo study

Status

Active, not recruiting

Phases

Phase 2

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON42305

Enrollment

Registered

2016-01-22

Start date

2016-08-09

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ovarian cancer

Interventions

Cisplatin

Ovarian Neoplasms

Pharmacokinetics

Predictive factors

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: Primary epitelial ovarían carcinoma FIGO stage III Optimal primary debulking (tumor rests 60 ml/min (Cockroft) Bilirubin and/or transaminases = 3. 10^6/L en Platelets >= 100. 10^6/L

Exclusion criteria

Exclusion criteria: Intestinal stoma proximal to the flexura lienalis Sepsis postoperative after primary debulking Extended intraperitoneal adhesions Neurotoxicity grade >1 Previous chemotherapy for ovarian carcinoma Symptomatic hearing loss Age >70 years old Haemoglobin

Design outcomes

Primary

Measure	Time frame
Patient data Patient data on age, tumor type, grade and stage, surgery type and outcome, I.P. chemotherapy dosing and toxicity, CA 125 and progression free survival (PFS ) site of recurrence (intraperitoneal versus extraperitoneal), overall survival (OS) . Immune Lab data The immune cells will be phenotyped to determine their nature (T cells, regulatory T cells, natural killer cells, dendritic cells, Myeloid-derived suppressor cells or macrophages M1 and M2 type), cytokine secretion and their functionality. If possible, cells will be frozen down for future analysis. STAT protein activation status of these cells will be determined alongside. Concurrently, a peripheral blood sample will be taken (5x 10 ml peripheral blood in heparin tubes on day 1 and day 8 of each round before i.p. chemo; to a maximum of 300 ml/year) and subjected to the same flowcytometry analysis of immune cell numbers, activation state and cytokine secretion as described above. Pharmacokinetic data: 6 ml of EDTA blood samples will be collected at 0, 15, 30, 60 min and at 2 h, 4 h, 8h, 16h, 24 h, 48hr and 72hr at the first i.p cycle of chemotherapy. to assess the concentrations of cisplatin and paclitaxel in the peripheral blood after IP administration.Also 3 ml intra-peritoneal fluid will be collected at time points -30 min 0 min, 15 min, 30 min, 60 min, 2hr , 4hr, 8h, 24h, 48 and 72 hr after i.p. infusion of cisplatin and paclitaxel.	—

Measure

Time frame

Patient data Patient data on age, tumor type, grade and stage, surgery type and outcome, I.P. chemotherapy dosing and toxicity, CA 125 and progression free survival (PFS ) site of recurrence (intraperitoneal versus extraperitoneal), overall survival (OS) . Immune Lab data The immune cells will be phenotyped to determine their nature (T cells, regulatory T cells, natural killer cells, dendritic cells, Myeloid-derived suppressor cells or macrophages M1 and M2 type), cytokine secretion and their functionality. If possible, cells will be frozen down for future analysis. STAT protein activation status of these cells will be determined alongside. Concurrently, a peripheral blood sample will be taken (5x 10 ml peripheral blood in heparin tubes on day 1 and day 8 of each round before i.p. chemo; to a maximum of 300 ml/year) and subjected to the same flowcytometry analysis of immune cell numbers, activation state and cytokine secretion as described above. Pharmacokinetic data: 6 ml of EDTA blood samples will be collected at 0, 15, 30, 60 min and at 2 h, 4 h, 8h, 16h, 24 h, 48hr and 72hr at the first i.p cycle of chemotherapy. to assess the concentrations of cisplatin and paclitaxel in the peripheral blood after IP administration.Also 3 ml intra-peritoneal fluid will be collected at time points -30 min 0 min, 15 min, 30 min, 60 min, 2hr , 4hr, 8h, 24h, 48 and 72 hr after i.p. infusion of cisplatin and paclitaxel.

—

Secondary

Measure	Time frame
Not applicable.	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)