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出境医 / 临床实验 / PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis (Nab-PIPAC)

PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis (Nab-PIPAC)

Study Description
Brief Summary:
Phase Ib trial including investigating the combination of nab-paclitaxel and cisplatin in patients diagnosed with peritoneal carcinomatosis related to pancreatic, oeso-gastric, ovarian cancer or primitive peritoneal mesothelioma.

Condition or disease Intervention/treatment Phase
Peritoneal Carcinomatosis Drug: Nab paclitaxel Drug: Cisplatin Phase 1

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib Trial of Intraperitoneal Cisplatin and Nab-paclitaxel Administered by Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in the Treatment of Advanced Malignancies Confined to the Peritoneal Cavity
Estimated Study Start Date : July 27, 2020
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : September 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: Experimental Arm
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin
Drug: 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)

Drug: Cisplatin
10.5 mg/m2

Outcome Measures
Primary Outcome Measures :
  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 Measures :
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

Contacts
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Contact: Intidhar Labidi-Galy, MD, PhD 0041 22 372 4014 intidhar.labidi-galy@hcuge.ch
Contact: Laura Le Bouil 0041 22 37 22 908 laura.lebouil@hcuge.ch

Locations
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Switzerland
University Hospital, Lausanne
Lausanne, Vaud, Switzerland, 1011
Contact: Antonella Diciolla, MD    0041 79 55 63 011    Antonella.Diciolla@chuv.ch   
University Hospital, Geneva
Geneva, Switzerland, 1211
Contact: Intidhar Labidi-Galy, MD, PhD    0041 22 372 4014    intidhar.labidi-galy@hcuge.ch   
Contact: Laura Le Bouil    0041 22 37 22 908    laura.lebouil@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Layout table for investigator information
Principal Investigator: Intidhar Labidi-Galy, MD, PhD University Hospital, Geneva
Tracking Information
First Submitted Date  ICMJE May 29, 2019
First Posted Date  ICMJE June 27, 2019
Last Update Posted Date July 29, 2020
Estimated Study Start Date  ICMJE July 27, 2020
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
Safety and tolerability of IP administration by PIPAC of Nab-paclitaxel (ABRAXANE®) and cisplatin. Measure of 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 ]
To determine the maximal tolerated dose (MTD) of Nab-paclitaxel (ABRAXANE®) administered IP by PIPAC in concomitance with cisplatin. MTD is defined as the lowest dose level at which ≥33% of patients experience dose limiting toxicity in accordance to CTCAE version 4.0 criteria.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 27, 2020)
  • 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)
  • 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).
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2019)
  • Free plasmatic concentration of paclitaxel [ Time Frame: First 48 hours of each cycle (each cycle is 28 days) ]
    Analysis of free plasmatic concentrations of paclitaxel will be performed at 0.5, 1, 4, 8, 24, 48 hours after the two first PIPAC treatment of each cohort
  • Free plasmatic concentration of cisplatin [ Time Frame: First 48 hours of each cycle (each cycle is 28 days) ]
    Analysis of plasmatic concentrations of cisplatin will be performed at 0.5, 1, 4, 8, 24, 48 hours after the two first PIPAC treatment of each cohort
  • Urinary platinum concentration [ Time Frame: First 48 hours of each cycle (each cycle is 28 days) ]
    Analysis of urinary Platinum concentration will be performed at 0, 4, 8, 24, 48 hours after the two first PIPAC treatment of each cohort
  • Objective histological regression [ Time Frame: Day 0 of each cycle (each cycle is 28 days) ]
    The histologic regression will be assessed by pathologic review of repeated peritoneal biopsies proceeded during laparoscopy before each PIPAC cycle, according to the new regression system for peritoneal cancer.
  • Objective tumor response rate [ Time Frame: Screening, Day 10 of Cycle 2, after completion of 3 cycles (each cycle is 28 days) ]
    Objective tumor response rate as defined by RECIST version 1.1 criteria
  • Benefit in Quality of Life [ Time Frame: Day-1 and Day 10 of each cycle, after completion of 3 cycles (each cycle is 28 days) ]
    The Quality of Life will be evaluated based on the EORTC questionnaire-C30 Version 3.0
  • Benefit in Quality of Life [ Time Frame: Day-1 and Day 10 of each cycle, after completion of 3 cycles (each cycle is 28 days) ]
    The Quality of Life will be evaluated based on visual analogic scale for pain (VAS scale). The VAS scale measures the pain from 0, the minimum pain, to 10 the maximum pain.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis
Official Title  ICMJE A Phase Ib Trial of Intraperitoneal Cisplatin and Nab-paclitaxel Administered by Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC) in the Treatment of Advanced Malignancies Confined to the Peritoneal Cavity
Brief Summary Phase Ib trial including investigating the combination of nab-paclitaxel and cisplatin in patients diagnosed with peritoneal carcinomatosis related to pancreatic, oeso-gastric, ovarian cancer or primitive peritoneal mesothelioma.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Peritoneal Carcinomatosis
Intervention  ICMJE
  • Drug: 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)
  • Drug: Cisplatin
    10.5 mg/m2
Study Arms  ICMJE Experimental: Experimental Arm
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin
Interventions:
  • Drug: Nab paclitaxel
  • Drug: Cisplatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 25, 2019)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2023
Estimated Primary Completion Date September 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Intidhar Labidi-Galy, MD, PhD 0041 22 372 4014 intidhar.labidi-galy@hcuge.ch
Contact: Laura Le Bouil 0041 22 37 22 908 laura.lebouil@hcuge.ch
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04000906
Other Study ID Numbers  ICMJE 2018-01327-Nab-PIPAC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intidhar Labidi-Galy, MD, PhD, University Hospital, Geneva
Study Sponsor  ICMJE University Hospital, Geneva
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Intidhar Labidi-Galy, MD, PhD University Hospital, Geneva
PRS Account University Hospital, Geneva
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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