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JOURNAL ONKOLOGIE – STUDIE
Nab-PIPAC

PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis

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NCT-Nummer:
NCT04000906

Studienbeginn:
Juli 2020

Letztes Update:
29.07.2020

Wirkstoff:
nab paclitaxel, Cisplatin

Indikation (Clinical Trials):
Carcinoma, Peritoneal Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
Phase 1

Sponsor:
University Hospital, Geneva

Collaborator:
-

Studienleiter

Intidhar Labidi-Galy, MD, PhD
Principal Investigator
University Hospital, Geneva

Kontakt

Studienlocations
(2 von 2)

University Hospital, Geneva
1211 Geneva
Switzerland» Google-Maps
Ansprechpartner:
Intidhar Labidi-Galy, MD, PhD
Phone: 0041 22 372 4014
E-Mail: intidhar.labidi-galy@hcuge.ch

Laura Le Bouil
Phone: 0041 22 37 22 908
E-Mail: laura.lebouil@hcuge.ch
» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Phase Ib trial investigating the combination of intraperitoneal Cisplatin (10.5 mg/m2) and Nab-paclitaxel (escalated dose from 7.5 mg/m2 to 70 mg/m2) administered by pressurized intraperitoneal aerosol chemotherapy (PIPAC) every 4-6 weeks for 3 cycles.

Ein-/Ausschlusskriterien

Inclusion criteria:

- Informed consent as documented by signature

- ≥18 years,

- psychologically able to follow the trial procedures

- with malignancy disease confined to the abdominal cavity (peritoneal carcinomatosis) from pancreatic, oeso-gastric, epithelial ovarian cancers (platinum resistant only) or primitive peritoneal mesothelioma,

- ECOG 0, 1 or 2,

- Life expectancy > 3 months,

- Not candidate for surgical cytoreduction and IP/HIPEC based on expert multidisciplinary board

- For whom standard therapies have been exhausted or not feasible (>1 line of treatment for platinum resistant epithelial ovarian carcinoma, oesgastric carcinoma, pancreatic carcinoma and primitive peritoneal mesothelioma)

Exclusion criteria:

- Extra-abdominal and intra-abdominal parenchymatous metastatic disease, with the exception of isolated pleural carcinomatosis/effusion or lymph node,

- Bowel obstruction, active gastro-duodenal ulcer or ongoing abdominal infection (bacterial, viral or fungal),

- Chemotherapy or surgery within the last two weeks prior to enrollment,

- Previous intra-abdominal chemotherapy,

- General or local (abdominal) contra-indications for laparoscopic surgery

- Known allergy to cisplatin or other platinum-containing compounds or to nab-paclitaxel,

- Progression while under or within 6 weeks of treatement by platinum

- Severe renal impairment (calculated GFR (CKD-EPI) < 60 mL/min/1.73 m2), myelosuppression (platelet count < 100.000/μl, hemoglobin < 9g/dl, neutrophil granulocytes < 1.500/ml), International Normalized Ratio (INR) > 2, severe hepatic (Serum total bilirubin > 1.5 mg/dl), respiratory or neurologic impairment (grade 3), severe myocardial insufficiency (NYHA class > 2), recent myocardial infarction, severe arrhythmias,

- Pregnancy or breastfeeding, women who can become pregnant must ensure effective contraception.

- Known or suspected non-compliance, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,

- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.

Studien-Rationale

Primary outcome:

1. Determine the maximal tolerated dose (MTD) of Nab paclitaxel (Abraxane®) administered IP by PIPAC in concomitance with cisplatin. (Time Frame - From the time of treatment randomization through 30 days following cessation of treatment):
MTD is defined as the lowest dose level at which ≥33% of patients' experience dose limiting toxicity in accordance to CTCAE version 5.0 criteria.



Secondary outcome:

1. Adverse events (AE) and serious adverse events (SAE) (Time Frame - D-1/D10 of each cycle):
AE and SAE with predefined toxicity criteria will be applied using CTCAE version 5.0 criteria, documented before and after each cycle of PIPAC treatment. Surgical complications will be assessed according to Clavien classification and comprehensive complication index (CCI)

2. The efficacy (Time Frame - D0 of each cycle):
It will be assessed by the objective histological regression and objective tumor response rate (OTR) according to the new regression system for peritoneal cancer (PRGS, peritoneal regression grade score system). The objective response rate (ORR), the clinical benefit rate (CBR) as defined by RECIST version 1.1 criteria and the relevance of radiological response assessed by CT enterography (CT-PCI score).

3. The QoL (Time Frame - D-1/D10 of each cycle):
QoL will be evaluated based on the EORTC questionnaire QLQ-C30 Version 3.0 and visual analogic scale for pain (VAS scale).

Studien-Arme

  • Experimental: Arm 1
    Dose escalated intraperitoneal Nab-paclitaxel (7.5 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
  • Experimental: Arm 2
    Dose escalated intraperitoneal Nab-paclitaxel (15 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
  • Experimental: Arm 3
    Dose escalated intraperitoneal Nab-paclitaxel (25 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
  • Experimental: Arm 4
    Dose escalated intraperitoneal Nab-paclitaxel (37.5 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
  • Experimental: Arm 5
    Dose escalated intraperitoneal Nab-paclitaxel (52.5 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
  • Experimental: Arm 6
    Dose escalated intraperitoneal Nab-paclitaxel (70 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy

Geprüfte Regime

  • Nab paclitaxel:
    Dose escalation (7.5 mg/m2, 15 mg/m2, 25 mg/m2, 37.5 mg/m2, 52.5 mg/m2 and 70 mg/m2)
  • Cisplatin:
    10.5 mg/m2

Quelle: ClinicalTrials.gov


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