PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis

Phase 1

Active, not recruiting

• Conditions: Peritoneal Carcinomatosis
• Interventions: Drug: Nab paclitaxel; Drug: Cisplatin

• Registration Number: NCT04000906
• Lead Sponsor: University Hospital, Geneva

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-05-29
• Study First Submitted QC: 2019-06-25
• Study First Posted: 2019-06-27
• Study Start: 2020-11-11
• Primary Completion: 2023-12-12
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-23
• Last Update Posted: 2024-05-24
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Experimental Arm	Nab paclitaxel	Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin
Experimental Arm	Cisplatin	Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin

Primary Outcome Measures

Name	Time	Method
Determine the maximal tolerated dose (MTD) of Nab paclitaxel (Abraxane®) administered IP by PIPAC in concomitance with cisplatin.	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

Name	Time	Method
Adverse events (AE) and serious adverse events (SAE)	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 QoL	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).
The efficacy	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).

Trial Locations

Locations (2)

University Hospital, Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland

University Hospital, Geneva; 🇨🇭 Geneva, Switzerland