Condition or disease | Intervention/treatment | Phase |
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Peritoneal Carcinomatosis | Drug: Nab paclitaxel Drug: Cisplatin | Phase 1 |
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 |
Arm | Intervention/treatment |
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Experimental: Experimental Arm
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin
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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
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Exclusion criteria:
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 |
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 |
Principal Investigator: | Intidhar Labidi-Galy, MD, PhD | University Hospital, Geneva |
Tracking Information | |||||||||
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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 |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
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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 |
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Condition ICMJE | Peritoneal Carcinomatosis | ||||||||
Intervention ICMJE |
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Study Arms ICMJE | Experimental: Experimental Arm
Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin
Interventions:
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Publications * | Not Provided | ||||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Not yet recruiting | ||||||||
Estimated Enrollment ICMJE |
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:
Exclusion criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
Accepts Healthy Volunteers ICMJE | No | ||||||||
Contacts ICMJE |
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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 |
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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 |
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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 |