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

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ClinicalTrials.gov Identifier: NCT04000906
Recruitment Status : Not yet recruiting
First Posted : June 27, 2019
Last Update Posted : June 27, 2019
Sponsor:
Information provided by (Responsible Party):
Francesco Sciotto, University Hospital, Geneva

Brief Summary:

Bicentric phase 1b dose escalation trial including 6 to 36 patients diagnosed with peritoneal carcinomatosis from pancreatic, oeso-gastric, epithelial ovarian cancers or primitive peritoneal mesothelioma.

After registration, the patient will receive intraperitoneal Nab-paclitaxel (escalated dose from 7.5 mg/m2 to 70 mg/m2) and Cisplatin (10.5 mg/m2) administered by pressurized intraperitoneal aerosol chemotherapy (PIPAC) every 4-6 weeks for 3 cycles.

All Dose Limiting Toxicities (DLT) will be permanently monitored in order to evaluate de Maximum Tolerated Dose. Assessment of plasmatic and urinary concentration of paclitaxel and cisplatin will be performed. The efficacy will be assessed by the objective histological regression and objective tumor response rate (OTR) according to the new regression system for peritoneal cancer. The quality of life will be evaluated based on the EORTC questionnaire quality of life questionnaire-C30 Version 3.0 and visual analogic scale for pain.


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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1b 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 : September 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2022


Arm Intervention/treatment
Experimental: Arm 1
Dose escalated intraperitoneal Nab-paclitaxel (7.5 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
Drug: NAB paclitaxel
Intraperitoneal (IP) administration by PIPAC of Nab-paclitaxel

Drug: Cisplatin
Intraperitoneal (IP) administration by PIPAC of Cisplatin

Experimental: Arm 2
Dose escalated intraperitoneal Nab-paclitaxel (15 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
Drug: NAB paclitaxel
Intraperitoneal (IP) administration by PIPAC of Nab-paclitaxel

Drug: Cisplatin
Intraperitoneal (IP) administration by PIPAC of Cisplatin

Experimental: Arm 3
Dose escalated intraperitoneal Nab-paclitaxel (25 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
Drug: NAB paclitaxel
Intraperitoneal (IP) administration by PIPAC of Nab-paclitaxel

Drug: Cisplatin
Intraperitoneal (IP) administration by PIPAC of Cisplatin

Experimental: Arm 4
Dose escalated intraperitoneal Nab-paclitaxel (37.5 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
Drug: NAB paclitaxel
Intraperitoneal (IP) administration by PIPAC of Nab-paclitaxel

Drug: Cisplatin
Intraperitoneal (IP) administration by PIPAC of Cisplatin

Experimental: Arm 5
Dose escalated intraperitoneal Nab-paclitaxel (52.5 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
Drug: NAB paclitaxel
Intraperitoneal (IP) administration by PIPAC of Nab-paclitaxel

Drug: Cisplatin
Intraperitoneal (IP) administration by PIPAC of Cisplatin

Experimental: Arm 6
Dose escalated intraperitoneal Nab-paclitaxel (70 mg/m2) and cisplatin (10.5 mg/m2) administration by pressurized intraperitoneal aerosol chemotherapy
Drug: NAB paclitaxel
Intraperitoneal (IP) administration by PIPAC of Nab-paclitaxel

Drug: Cisplatin
Intraperitoneal (IP) administration by PIPAC of Cisplatin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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

  7. 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.



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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:

  • psychologically able to follow the trial procedures and to give a written informed consent,
  • with malignancy disease confined to the abdominal cavity (peritoneal carcinomatosis) from pancreatic, oeso-gastric, epithelial ovarian cancers (platinum resistant only) or primitive peritoneal mesothelioma,
  • Eastern Cooperative Oncology Group status 0, 1 or 2,
  • Life expectancy more than 3 months,
  • Not candidate for surgical cytoreduction and IP-Hyperthermic Intraoperative Intraperitoneal Chemotherapy based on expert multidisciplinary board
  • For whom standard therapies have been exhausted or not feasible (more than 1 line of treatment for platin resistant epithelial ovarian carcinoma, oeso-gastric 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 abdominal lymph node metastasis,
  • 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,
  • Severe renal impairment (calculated glomerular filtration rate (CKD-EPI) inferior 60 mL/min/1.73 m2), myelosuppression (platelet count inferior 100.000/µl, hemoglobin less than 9g/dl, neutrophil granulocytes less than 1.500/ml), International Normalized Ratio (INR) more than 2, severe hepatic (Serum total bilirubin more than 1.5 mg/dl), respiratory or neurologic impairment, severe myocardial insufficiency (NYHA class more than 2), recent myocardial infarction, severe arrhythmias,
  • Pregnancy or breastfeeding, women who can become pregnant must ensure effective contraception.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04000906


Contacts
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Contact: Francesco Sciotto, MD 0041 79 55 35 099 Francesco.Sciotto@hcuge.ch
Contact: Laura Le Bouil 0041 22 37 22 908 laura.lebouil@hcuge.ch

Locations
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Switzerland
University Hospital, Lausanne Not yet recruiting
Lausanne, Vaud, Switzerland, 1011
Contact: Antonella Diciolla, MD    0041 79 55 63 011    Antonella.Diciolla@chuv.ch   
University Hospital, Geneva Not yet recruiting
Geneva, Switzerland, 1211
Contact: Francesco Sciotto, MD    0041 79 55 35 099    francesco.sciotto@hcuge.ch   
Contact: Laura Le Bouil    0041 22 37 22 908    laura.lebouil@hcuge.ch   
Sponsors and Collaborators
University Hospital, Geneva
Investigators
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Principal Investigator: Francesco Sciotto, MD University Hospital, Geneva

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Responsible Party: Francesco Sciotto, Medical Doctor, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT04000906     History of Changes
Other Study ID Numbers: 2018-01327-Nab-PIPAC
First Posted: June 27, 2019    Key Record Dates
Last Update Posted: June 27, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francesco Sciotto, University Hospital, Geneva:
pancreatic cancer
oeso-gastric cancer
epithelial ovarian cancer
primitive peritoneal mesothelioma
Additional relevant MeSH terms:
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Carcinoma
Peritoneal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Abdominal Neoplasms
Neoplasms by Site
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Cisplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action