Peritoneal CarcinomatosisPhase 1PIPAC-nabpacNCT03304210
PIPAC Nab-pac for Stomach, Pancreas, Breast and Ovarian Cancer
A Phase 1 study testing PIPAC with Abraxane in people with Peritoneal Carcinomatosis and Ovarian Cancer Stage IIIB, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
The PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis, Ovarian Cancer Stage IIIB, Ovarian Cancer Stage IIIC
- What is being tested?
- PIPAC with Abraxane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 16 Sep 2017to 6 May 2020
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Phase I study: patients with advanced carcinomatosis from ovarian, breast, gastric, or pancreatic origin. No alternative systemic treatment options are available.
- Age over 18 years
- Adequate performance status (Karnofsky index > 60%)
- Absence of intestinal or urinary obstruction
- Limited size of the majority of peritoneal tumor implants (< 5 mm)
- Absent or limited ascites
Show all 18Show fewer
- Ability to understand the proposed treatment protocol and provide informed consent
- Expected life expectancy more than 6 months
- Laboratory data
- Serum creatinine ≤ 1.5 mg/dl or a calculated GFR (CKD-EPI) ≥ 60 mL/min/1.73 m²
- Serum total bilirubin ≤ 1.5 mg/dl, except for known Gilbert's disease
- Platelet count > 100.000/µl
- Hemoglobin > 9g/dl
- Neutrophil granulocytes > 1.500/ml
- No major blood coagulation disorders. Parameters within normal range.
- Absence of alcohol and/or drug abuse
- No other concurrent malignant disease
- Written informed consent
Who cannot join
- Pregnancy or breast feeding. Women who can become pregnant must ensure effective contraception.
- Active bacterial, viral or fungal infection
- Active gastro-duodenal ulcer
- Parenchymal liver disease (any stage cirrhosis)
- Uncontrolled diabetes mellitus
- Psychiatric pathology affecting comprehension and judgement faculty
Show all 9Show fewer
- General or local (abdominal) contra-indications for laparoscopic surgery
- Documented intolerance or allergy to paclitaxel
- Patients who receive other taxane therapy until three weeks before the first experimental treatment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraperitoneal Aerosolization of Albumin-stabilized Paclitaxel Nanoparticles for Stomach, Pancreas, Breast and Ovarian Cancer
The PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial.
Read the detailed description
Over 85% of women with ovarian cancer (OC) will develop a peritoneal recurrence after initial therapy. The prognosis of patients with recurrent disease is poor, with a median survival ranging from 12 to 24 months. Most of these patients ultimately develop platinum resistant disease (PROC). Current systemic therapy results in a very modest improvement of progression free and overall survival. The addition of locoregional, intraperitoneal (IP) therapy may improve disease control in recurrent OC. Recently, pressurized intraperitoneal aerosol therapy (PIPAC) was added to the therapeutic arsenal. This novel technique allows repeated laparoscopy aided aerosol delivery of anticancer drugs to the peritoneal cavity. Abraxane (nab-pac, Celgene) is a novel 130 nm, albumin-bound (nab) nanoparticle formulation of paclitaxel which has noteworthy single-agent activity and a favourable toxicity profile when used systemically in PROC. A recent phase I study showed a significant pharmacokinetic advantage after IP instillation of nab-pac in patients with peritoneal carcinomatosis from ovarian or gastro-intestinal (GI) origin.
In phase I of this study, dose escalation will be combined with pharmacokinetic/pharmacodynamic modelling which incorporates, in addition to plasma, tumour tissue, and peritoneal drug concentrations, biomarkers of toxicity and efficacy.
- Conditions
- Peritoneal Carcinomatosis, Ovarian Cancer Stage IIIB, Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV, Breast Cancer Stage IIIB, Breast Cancer Stage IIIc
- Being tested
- PIPAC with Abraxane
- Keywords
- PIPAC, Peritoneal carcinomatosis, Ovarian cancer, Pharmacokinetics, Pharmacodynamics, Safety and efficacy, Abraxane, Breast cancer, Pancreas cancer, Stomach cancer
- Medical subject headings
- Peritoneal Neoplasms, Ovarian Neoplasms, Breast Neoplasms, Stomach Neoplasms, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIPAC with AbraxaneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Abraxane 35 mg/m² | Experimental | PIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles. Receives: Drug: PIPAC with Abraxane |
| Abraxane 70 mg/m² | Experimental | PIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. Receives: Drug: PIPAC with Abraxane |
| Abraxane 90 mg/m² | Experimental | PIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. Receives: Drug: PIPAC with Abraxane |
| Abraxane 112.5 mg/m² | Experimental | PIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. Receives: Drug: PIPAC with Abraxane |
| Abraxane 140 mg/m² | Experimental | PIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. Receives: Drug: PIPAC with Abraxane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximally Tolerated Dose (MTD) of Abraxane
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.
Measured: Within 14 weeks of the start of the treatment
Secondary outcomes (6)
Surgical Morbidity
Surgical 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
Measured: 6 months after third PIPAC
Maximum Plasma Concentration of Abraxane
Abraxane will be measured in plasma, using UPLC-MS/MS.
Measured: 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 hours
Area Under The Curve (AUC) of Abraxane
Abraxane will be measured in plasma, using LC-MS/MS.
Measured: 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 hours
Histological Response Via Peritoneal Regression Grading Scoring (PRGS)
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.
Measured: T = 0 minutes, before nebulization
Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Blood samples will be collected to analyse the absolute neutrophil count
Measured: Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC
Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Blood samples will be collected to analyse the amount of platelets.
Measured: Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2017
- Study start16 Sep 2017
- Primary completion6 May 2020
- Study completion6 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peritoneal CarcinomatosisStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Kom Op Tegen Kanker, University Ghent, Hopital Lariboisière, University Women's Hospital Tübingen, Candiolo Cancer Institute - IRCCS, Centre Hospitalier Universitaire Vaudois
- Responsible party
- Sponsor
- Investigators
- Wim P Ceelen, MD, PhD, Prof, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03304210
- Sponsor's protocol ID
- AGO/2017/003
- Acronym
- PIPAC-nabpac
- Status last verified
- Jan 2023
- First submitted
- 11 Sep 2017
- Last updated
- 7 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van De Sande L, Graversen M, Hubner M, Pocard M, Reymond M, Vaira M, Cosyns S, Willaert W, Ceelen W. Intraperitoneal aerosolization of albumin-stabilized paclitaxel nanoparticles (Abraxane) for peritoneal carcinomatosis - a phase I first-in-human study. Pleura Peritoneum. 2018 Jun 8;3(2):20180112. doi: 10.1515/pp-2018-0112. eCollection 2018 Jun 1.
PubMed 30911657Ceelen W, Sandra L, de Sande LV, Graversen M, Mortensen MB, Vermeulen A, Gasthuys E, Reynders D, Cosyns S, Hoorens A, Willaert W. Phase I study of intraperitoneal aerosolized nanoparticle albumin based paclitaxel (NAB-PTX) for unresectable peritoneal metastases. EBioMedicine. 2022 Aug;82:104151. doi: 10.1016/j.ebiom.2022.104151. Epub 2022 Jul 15.
PubMed 35843174
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraperitoneal Aerosolization of Albumin-stabilized Paclitaxel Nanoparticles for Stomach, Pancreas, Breast and Ovarian Cancer
- ClinicalTrials.gov ID
- NCT03304210
- Acronym / sponsor ID
- PIPAC-nabpac / AGO/2017/003
- Conditions
- Peritoneal Carcinomatosis, Ovarian Cancer Stage IIIB, Ovarian Cancer Stage IIIC, Ovarian Cancer Stage IV, Breast Cancer Stage IIIB, Breast Cancer Stage IIIc
- Keywords
- PIPAC, Peritoneal carcinomatosis, Ovarian cancer, Pharmacokinetics, Pharmacodynamics, Safety and efficacy, Abraxane, Breast cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Kom Op Tegen Kanker, University Ghent, Hopital Lariboisière, University Women's Hospital Tübingen, Candiolo Cancer Institute - IRCCS, Centre Hospitalier Universitaire Vaudois
- Study start
- 16 Sep 2017 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 6 May 2020 (actual)
- First posted
- 6 Oct 2017 (actual)
- Results
- Posted 7 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The PIPAC nab-pac study is designed to examine the maximal tolerated dose of albumin bound nanoparticle paclitaxel (nab-pac, Abraxane) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a multicentre, multinational phase I trial.
Detailed description
Over 85% of women with ovarian cancer (OC) will develop a peritoneal recurrence after initial therapy. The prognosis of patients with recurrent disease is poor, with a median survival ranging from 12 to 24 months. Most of these patients ultimately develop platinum resistant disease (PROC). Current systemic therapy results in a very modest improvement of progression free and overall survival. The addition of locoregional, intraperitoneal (IP) therapy may improve disease control in recurrent OC. Recently, pressurized intraperitoneal aerosol therapy (PIPAC) was added to the therapeutic arsenal. This novel technique allows repeated laparoscopy aided aerosol delivery of anticancer drugs to the peritoneal cavity. Abraxane (nab-pac, Celgene) is a novel 130 nm, albumin-bound (nab) nanoparticle formulation of paclitaxel which has noteworthy single-agent activity and a favourable toxicity profile when used systemically in PROC. A recent phase I study showed a significant pharmacokinetic advantage after IP instillation of nab-pac in patients with peritoneal carcinomatosis from ovarian or gastro-intestinal (GI) origin.
In phase I of this study, dose escalation will be combined with pharmacokinetic/pharmacodynamic modelling which incorporates, in addition to plasma, tumour tissue, and peritoneal drug concentrations, biomarkers of toxicity and efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Abraxane 35 mg/m² | Experimental | Drug: PIPAC with AbraxanePIPAC with Abraxane (35 mg/m²) will be administered every 4 weeks for 3 cycles. |
| Abraxane 70 mg/m² | Experimental | Drug: PIPAC with AbraxanePIPAC with Abraxane (70 mg/m²) will be administered every 4 weeks for 3 cycles. |
| Abraxane 90 mg/m² | Experimental | Drug: PIPAC with AbraxanePIPAC with Abraxane (90 mg/m²) will be administered every 4 weeks for 3 cycles. |
| Abraxane 112.5 mg/m² | Experimental | Drug: PIPAC with AbraxanePIPAC with Abraxane (112.5 mg/m²) will be administered every 4 weeks for 3 cycles. |
| Abraxane 140 mg/m² | Experimental | Drug: PIPAC with AbraxanePIPAC with Abraxane (140 mg/m²) will be administered every 4 weeks for 3 cycles. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Phase I study: patients with advanced carcinomatosis from ovarian, breast, gastric, or pancreatic origin. No alternative systemic treatment options are available.
- Age over 18 years
- Adequate performance status (Karnofsky index > 60%)
- Absence of intestinal or urinary obstruction
- Limited size of the majority of peritoneal tumor implants (< 5 mm)
Key exclusion criteria (9 listed)
- Pregnancy or breast feeding. Women who can become pregnant must ensure effective contraception.
- Active bacterial, viral or fungal infection
- Active gastro-duodenal ulcer
- Parenchymal liver disease (any stage cirrhosis)
- Uncontrolled diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIPAC with AbraxaneAlbumin 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. | Drug | Abraxane 112.5 mg/m², Abraxane 140 mg/m², Abraxane 35 mg/m², Abraxane 70 mg/m², Abraxane 90 mg/m² |
Primary outcome
Maximally Tolerated Dose (MTD) of Abraxane
Time frame: Within 14 weeks of the start of the treatment
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.
6 secondary outcomes
Surgical Morbidity
Time frame: 6 months after third PIPAC
Maximum Plasma Concentration of Abraxane
Time frame: 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 hours
Area Under The Curve (AUC) of Abraxane
Time frame: 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 hours
Histological Response Via Peritoneal Regression Grading Scoring (PRGS)
Time frame: T = 0 minutes, before nebulization
Neutropenia - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC
Decreased Platelets - Number of Participants With Treatment-related Adverse Events as Assessed by CTCAE v4.0
Time frame: Pre-operatively, and 12 hours, 24 hours and 1 week after each PIPAC
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30911657Van De Sande L, Graversen M, Hubner M, Pocard M, Reymond M, Vaira M, Cosyns S, Willaert W, Ceelen W. Intraperitoneal aerosolization of albumin-stabilized paclitaxel nanoparticles (Abraxane) for peritoneal carcinomatosis - a phase I first-in-human study. Pleura Peritoneum. 2018 Jun 8;3(2):20180112. doi: 10.1515/pp-2018-0112. eCollection 2018 Jun 1.
- Results publication: PubMed 35843174Ceelen W, Sandra L, de Sande LV, Graversen M, Mortensen MB, Vermeulen A, Gasthuys E, Reynders D, Cosyns S, Hoorens A, Willaert W. Phase I study of intraperitoneal aerosolized nanoparticle albumin based paclitaxel (NAB-PTX) for unresectable peritoneal metastases. EBioMedicine. 2022 Aug;82:104151. doi: 10.1016/j.ebiom.2022.104151. Epub 2022 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wim P Ceelen, MD, PhD, Prof principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PIPAC with Abraxane in people with Peritoneal Carcinomatosis and Ovarian Cancer Stage IIIB, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Nov 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximally Tolerated Dose (MTD) of Abraxane (time frame: Within 14 weeks of the start of the treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03304210, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.