Trial Outcomes & Findings for PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer (NCT NCT03304210)
NCT ID: NCT03304210
Last Updated: 2023-11-07
Results Overview
The MTD was defined as the highest dose of aerosolized Abraxane, administered 3 times using PIPAC, that does not cause unacceptable side effects. Dose limiting toxicity was recorded in a 14 week-window starting from the first PIPAC and defined a priori as any of the following: 1. any Grade 3 or 4 non-hematologic toxicity excluding fatigue and controllable nausea, vomiting, abdominal pain, and diarrhoea; 2. grade 4 thrombocytopenia; 3. grade 4 neutropenia lasting more than 7 days or associated with fever; 4. failure to perform more than one PIPAC due to toxicity; 5. surgical complication Dindo-Clavien grade IIIB or higher. In order to optimize the balance between safety and efficacy, we used a time-to-event continual reassessment model (TITE-CRM), where an initial design was followed until the first DLT occurred. Conservative a priori estimates of DLT were used to calculate the original dose escalation scheme.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
20 participants
Primary outcome timeframe
Within 14 weeks of the start of the treatment
Results posted on
2023-11-07
Participant Flow
Participant milestones
| Measure |
Abraxane 35 mg/m²
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
3
|
3
|
10
|
|
Overall Study
COMPLETED
|
2
|
2
|
3
|
3
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Abraxane 35 mg/m²
n=2 Participants
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 Participants
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 Participants
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 Participants
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=10 Participants
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=3 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
9 Participants
n=10 Participants
|
15 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
1 Participants
n=10 Participants
|
5 Participants
n=20 Participants
|
|
Age, Continuous
|
64 years
n=2 Participants
|
68 years
n=2 Participants
|
52 years
n=3 Participants
|
59 years
n=3 Participants
|
51 years
n=10 Participants
|
57 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=2 Participants
|
2 Participants
n=2 Participants
|
0 Participants
n=3 Participants
|
2 Participants
n=3 Participants
|
7 Participants
n=10 Participants
|
12 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=2 Participants
|
0 Participants
n=2 Participants
|
3 Participants
n=3 Participants
|
1 Participants
n=3 Participants
|
3 Participants
n=10 Participants
|
8 Participants
n=20 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Within 14 weeks of the start of the treatmentThe MTD was defined as the highest dose of aerosolized Abraxane, administered 3 times using PIPAC, that does not cause unacceptable side effects. Dose limiting toxicity was recorded in a 14 week-window starting from the first PIPAC and defined a priori as any of the following: 1. any Grade 3 or 4 non-hematologic toxicity excluding fatigue and controllable nausea, vomiting, abdominal pain, and diarrhoea; 2. grade 4 thrombocytopenia; 3. grade 4 neutropenia lasting more than 7 days or associated with fever; 4. failure to perform more than one PIPAC due to toxicity; 5. surgical complication Dindo-Clavien grade IIIB or higher. In order to optimize the balance between safety and efficacy, we used a time-to-event continual reassessment model (TITE-CRM), where an initial design was followed until the first DLT occurred. Conservative a priori estimates of DLT were used to calculate the original dose escalation scheme.
Outcome measures
| Measure |
Abraxane 35 mg/m²
n=2 Participants
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 Participants
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 Participants
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 Participants
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=10 Participants
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Maximally Tolerated Dose (MTD) of Abraxane
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 6 months after third PIPACSurgical complications were scored using the Clavien Dindo classification. Grade I: Any deviation from the normal post-operative course not requiring surgical, endoscopic or radiological intervention. This includes the need for certain drugs (e.g. antiemetics, antipyretics, analgesics, diuretics and electrolytes), treatment with physiotherapy and wound infections that are opened at the bedside Grade II: Complications requiring drug treatments other than those allowed for Grade I complications; this includes blood transfusion and total parenteral nutrition (TPN) Grade III: Complications requiring surgical, endoscopic or radiological intervention Grade IV: Life-threatening complications; this includes CNS complications (e.g. brain haemorrhage, ischaemic stroke, subarachnoid haemorrhage) which require intensive care, but excludes transient ischaemic attacks (TIAs) Grade V: Death of the patient
Outcome measures
| Measure |
Abraxane 35 mg/m²
n=2 Participants
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 Participants
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 Participants
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 Participants
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=10 Participants
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Surgical Morbidity
|
2 participants
|
2 participants
|
3 participants
|
3 participants
|
10 participants
|
SECONDARY outcome
Timeframe: T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hoursAbraxane will be measured in plasma, using UPLC-MS/MS.
Outcome measures
| Measure |
Abraxane 35 mg/m²
n=2 Participants
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 Participants
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 Participants
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 Participants
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=10 Participants
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Maximum Plasma Concentration of Abraxane
|
58 ng/mL
Standard Deviation 15
|
138 ng/mL
Standard Deviation 42
|
101 ng/mL
Standard Deviation 13
|
157 ng/mL
Standard Deviation 49
|
184 ng/mL
Standard Deviation 68
|
SECONDARY outcome
Timeframe: T = 0 minutes, T = 15 minutes, T = 30 minutes, T = 60 minutes, T = 1.5 hour, T = 2 hours, T = 4 hours, T = 8 hours, T = 12 hours, T = 24 hoursAbraxane will be measured in plasma, using LC-MS/MS.
Outcome measures
| Measure |
Abraxane 35 mg/m²
n=2 Participants
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 Participants
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 Participants
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 Participants
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=10 Participants
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Area Under The Curve (AUC) of Abraxane
|
585 h*ng/mL
Standard Deviation 93
|
962 h*ng/mL
Standard Deviation 237
|
813 h*ng/mL
Standard Deviation 99
|
1658 h*ng/mL
Standard Deviation 465
|
2002 h*ng/mL
Standard Deviation 569
|
SECONDARY outcome
Timeframe: T = 0 minutes, before nebulizationPopulation: Tumour tissue samples were taken from each abdominal quadrant (n = 4) before aerosol delivery. In 30% of all procedures, less than four biopsies (or none) were taken due to technical reasons (adhesions) or because no visible tumour was present, which explains the lower number of participants analyzed.
Punch biopsies are taken at the same location, which are marked with a stainless-steel surgical clip during each PIPAC procedure. Samples are fixed in 4% paraformaldehyde in PBS for 72 hours and embedded in paraffin. Tissues are serially sectioned and stained with haematoxylin \& eosin; immunohistochemical staining is performed for epithelial cellular adhesion molecule (EpCAM). The peritoneal regression grading score (PRGS) is determined by a GI pathologist. The mean score of all samples is calculated per treatment, and percentage changes in mean PRGS between successive PIPAC treatments is calculated. The unit of measure represented is the amount of participants in which tumor regression was observed.
Outcome measures
| Measure |
Abraxane 35 mg/m²
n=1 Participants
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 Participants
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 Participants
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 Participants
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=8 Participants
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Histological Response Via Peritoneal Regression Grading Scoring (PRGS)
|
0 participants with tumor regression
|
1 participants with tumor regression
|
1 participants with tumor regression
|
0 participants with tumor regression
|
7 participants with tumor regression
|
SECONDARY outcome
Timeframe: Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPACBlood samples will be collected to analyse the absolute neutrophil count
Outcome measures
| Measure |
Abraxane 35 mg/m²
n=2 Participants
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 Participants
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 Participants
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 Participants
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=10 Participants
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
CTCAE grade <=2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
|
Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
CTCAE grade >2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
no neutropenia
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPACBlood samples will be collected to analyse the amount of platelets.
Outcome measures
| Measure |
Abraxane 35 mg/m²
n=2 Participants
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 Participants
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 Participants
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 Participants
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=10 Participants
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
CTCAE grade <=2
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
CTCAE grade >2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
no thrombopenia
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
Adverse Events
Abraxane 35 mg/m²
Serious events: 2 serious events
Other events: 2 other events
Deaths: 1 deaths
Abraxane 70 mg/m²
Serious events: 2 serious events
Other events: 2 other events
Deaths: 2 deaths
Abraxane 90 mg/m²
Serious events: 2 serious events
Other events: 3 other events
Deaths: 1 deaths
Abraxane 112.5 mg/m²
Serious events: 1 serious events
Other events: 3 other events
Deaths: 1 deaths
Abraxane 140 mg/m²
Serious events: 6 serious events
Other events: 10 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Abraxane 35 mg/m²
n=2 participants at risk
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 participants at risk
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 participants at risk
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 participants at risk
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=10 participants at risk
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Redness
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/10 • 6 months
|
|
Gastrointestinal disorders
intestine obstruction
|
50.0%
1/2 • Number of events 2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/10 • 6 months
|
|
Blood and lymphatic system disorders
thrombocytopenia grade 3 (CTCAE)
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/10 • 6 months
|
|
General disorders
progression peritoneal disease leading to death
|
50.0%
1/2 • Number of events 1 • 6 months
|
100.0%
2/2 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
surgical wound infection
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
2/10 • Number of events 2 • 6 months
|
|
Surgical and medical procedures
anaphylactic shock during surgery
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Infections and infestations
infection peritoneum
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
General disorders
anorexia
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
Other adverse events
| Measure |
Abraxane 35 mg/m²
n=2 participants at risk
PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 70 mg/m²
n=2 participants at risk
PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 90 mg/m²
n=3 participants at risk
PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 112.5 mg/m²
n=3 participants at risk
PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
Abraxane 140 mg/m²
n=10 participants at risk
PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles.
PIPAC with Abraxane: Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
thrombopenia
|
0.00%
0/2 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
30.0%
3/10 • Number of events 3 • 6 months
|
|
Blood and lymphatic system disorders
white blood cell decreased
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
30.0%
3/10 • Number of events 3 • 6 months
|
|
Blood and lymphatic system disorders
neutropenia
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
50.0%
5/10 • Number of events 5 • 6 months
|
|
Blood and lymphatic system disorders
anemia
|
0.00%
0/2 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
90.0%
9/10 • Number of events 9 • 6 months
|
|
Metabolism and nutrition disorders
elevated AST
|
100.0%
2/2 • Number of events 2 • 6 months
|
100.0%
2/2 • Number of events 2 • 6 months
|
100.0%
3/3 • Number of events 3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
60.0%
6/10 • Number of events 6 • 6 months
|
|
Metabolism and nutrition disorders
elevated ALT
|
50.0%
1/2 • Number of events 1 • 6 months
|
100.0%
2/2 • Number of events 2 • 6 months
|
100.0%
3/3 • Number of events 3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
40.0%
4/10 • Number of events 4 • 6 months
|
|
Metabolism and nutrition disorders
elevated ALP
|
0.00%
0/2 • 6 months
|
100.0%
2/2 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
40.0%
4/10 • Number of events 4 • 6 months
|
|
Metabolism and nutrition disorders
elevated bilirubin
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
20.0%
2/10 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
elevated GGT
|
50.0%
1/2 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
70.0%
7/10 • Number of events 7 • 6 months
|
|
Metabolism and nutrition disorders
hyperglycemia
|
50.0%
1/2 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
80.0%
8/10 • Number of events 8 • 6 months
|
|
Metabolism and nutrition disorders
hyperkalemia
|
0.00%
0/2 • 6 months
|
100.0%
2/2 • Number of events 2 • 6 months
|
66.7%
2/3 • Number of events 2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
30.0%
3/10 • Number of events 3 • 6 months
|
|
Metabolism and nutrition disorders
hypokalemia
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
20.0%
2/10 • Number of events 2 • 6 months
|
|
Metabolism and nutrition disorders
hypernatremia
|
0.00%
0/2 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/10 • 6 months
|
|
Surgical and medical procedures
bleeding at incision
|
0.00%
0/2 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/10 • 6 months
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
20.0%
2/10 • Number of events 2 • 6 months
|
|
Gastrointestinal disorders
vomiting
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
adhesions
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Gastrointestinal disorders
diarrhea
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/10 • 6 months
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
30.0%
3/10 • Number of events 3 • 6 months
|
|
Gastrointestinal disorders
paralytic ileus
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Vascular disorders
hypertension
|
50.0%
1/2 • Number of events 1 • 6 months
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
70.0%
7/10 • Number of events 7 • 6 months
|
|
Cardiac disorders
electrocardiogram T wave abnormal
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/10 • 6 months
|
|
Respiratory, thoracic and mediastinal disorders
bacterial pneumonia
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
0.00%
0/10 • 6 months
|
|
Skin and subcutaneous tissue disorders
skin infection
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Surgical and medical procedures
surgical wound infection
|
50.0%
1/2 • Number of events 1 • 6 months
|
0.00%
0/2 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
40.0%
4/10 • Number of events 4 • 6 months
|
|
Infections and infestations
peritoneal infection
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
33.3%
1/3 • Number of events 1 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
General disorders
edema lower limbs
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
|
Nervous system disorders
peripheral sensory neuropathy
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
30.0%
3/10 • Number of events 3 • 6 months
|
|
Immune system disorders
allergic reaction to anesthesia
|
0.00%
0/2 • 6 months
|
0.00%
0/2 • 6 months
|
0.00%
0/3 • 6 months
|
0.00%
0/3 • 6 months
|
10.0%
1/10 • Number of events 1 • 6 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place