Peritoneal CarcinomatosisPhase 1Nab-PIPACNCT04000906
PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis
A Phase 1 study testing Nab paclitaxel and Cisplatin in people with Peritoneal Carcinomatosis, run by University Hospital, Geneva at 2 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peritoneal Carcinomatosis
- What is being tested?
- Nab paclitaxel and Cisplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 11 Nov 2020to Dec 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- Informed consent as documented by signature
- ≥18 years,
- psychologically able to follow the trial procedures
- with peritoneal carcinomatosis from pancreatic, oesogastric, epithelial ovarian cancers or primitive peritoneal mesothelioma,
- ECOG 0, 1 or 2,
- Life expectancy > 3 months,
- Not candidate for surgical cytoreduction and IP/HIPEC based on expert multidisciplinary board
- who received at least one line of chemotherapy and for whom standard therapies have been exhausted or not feasible. patients with residual disease following the first line of therapy or Following secondary debulking are eligible.
Who cannot join
- Predominant extra-peritoneal metastases at the discretion of the study team after discussion at the multidisciplinary board,
- 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,
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- Severe renal impairment (calculated GFR (CKD-EPI) < 60 mL/min/1.73 m2), myelosuppression (platelet count < 100.000/μl, hemoglobin < 9g/dl, neutrophil granulocytes < 1.500/ml), International Normalized Ratio (INR) > 2, severe hepatic (Serum total bilirubin > 1.5 mg/dl), respiratory or neurologic impairment (grade 3), severe myocardial insufficiency (NYHA class > 2), recent myocardial infarction, severe arrhythmias,
- Pregnancy or breastfeeding, women who can become pregnant must ensure effective contraception.
- Known or suspected non-compliance, inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- 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.
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
University Hospital, Geneva
Geneva, 1211
University Hospital, Lausanne
Lausanne, Canton of Vaud, 1011
About this study
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
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.
Read the 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.
- Conditions
- Peritoneal Carcinomatosis
- Being tested
- Nab paclitaxel, Cisplatin
- Keywords
- pancreatic cancer, oeso-gastric cancer, epithelial ovarian cancer, primitive peritoneal mesothelioma
- Medical subject headings
- Peritoneal Neoplasms, Pancreatic Neoplasms, Carcinoma, Ovarian Epithelial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nab paclitaxelDrug
Dose escalation (7.5 mg/m2, 15 mg/m2, 25 mg/m2, 37.5 mg/m2, 52.5 mg/m2 and 70 mg/m2)
CisplatinDrug
10.5 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Experimental Arm | Experimental | Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin Receives: Drug: Nab paclitaxel; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 5.0 criteria.
Measured: From the time of treatment randomization through 30 days following cessation of treatment
Secondary outcomes (3)
Adverse events (AE) and serious adverse events (SAE)
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)
Measured: D-1/D10 of each cycle
The efficacy
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).
Measured: D0 of each cycle
The QoL
QoL will be evaluated based on the EORTC questionnaire QLQ-C30 Version 3.0 and visual analogic scale for pain (VAS scale).
Measured: D-1/D10 of each cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2019
- Study start11 Nov 2020
- Primary completion12 Dec 2023
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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, GenevaThe 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
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Intidhar Labidi-Galy, MD, PhD, University Hospital, Geneva
- Investigators
- Intidhar Labidi-Galy, MD, PhD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04000906
- Sponsor's protocol ID
- 2018-01327-Nab-PIPAC
- Other IDs
- 2018
- Acronym
- Nab-PIPAC
- Status last verified
- May 2024
- First submitted
- 29 May 2019
- Last updated
- 24 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The only clinical data available to researchers will be anonymised. Requests may be directed to Sponsor Investigator or designee. The informed consent form and clinical study report will be made available
Publications
Lang N, Diciola A, Labidi-Galy I, Ris F, Di Marco M, Mach N, Petignat P, Toso C, Undurraga M, Hubner M. Nab-PIPAC: a phase IB study protocol of intraperitoneal cisplatin and nab-paclitaxel administered by pressurised intraperitoneal aerosol chemotherapy (PIPAC) in the treatment of advanced malignancies confined to the peritoneal cavity. BMJ Open. 2023 Jan 5;13(1):e067691. doi: 10.1136/bmjopen-2022-067691.
PubMed 36604127
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04000906
- Acronym / sponsor ID
- Nab-PIPAC / 2018-01327-Nab-PIPAC
- Conditions
- Peritoneal Carcinomatosis
- Keywords
- pancreatic cancer, oeso-gastric cancer, epithelial ovarian cancer, primitive peritoneal mesothelioma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 11 Nov 2020 (actual)
- Primary completion
- 12 Dec 2023 (actual)
- Study completion
- Dec 2024 (estimated)
- First posted
- 27 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Arm | Experimental | Drug: Nab paclitaxel, Drug: CisplatinPressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent as documented by signature
- ≥18 years,
- psychologically able to follow the trial procedures
- with peritoneal carcinomatosis from pancreatic, oesogastric, epithelial ovarian cancers or primitive peritoneal mesothelioma,
- ECOG 0, 1 or 2,
Key exclusion criteria (10 listed)
- Predominant extra-peritoneal metastases at the discretion of the study team after discussion at the multidisciplinary board,
- 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
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 |
|---|---|---|
| Nab paclitaxelDose escalation (7.5 mg/m2, 15 mg/m2, 25 mg/m2, 37.5 mg/m2, 52.5 mg/m2 and 70 mg/m2) | Drug | Experimental Arm |
| Cisplatin10.5 mg/m2 | Drug | Experimental Arm |
Primary outcome
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.
3 secondary outcomes
Adverse events (AE) and serious adverse events (SAE)
Time frame: D-1/D10 of each cycle
The efficacy
Time frame: D0 of each cycle
The QoL
Time frame: D-1/D10 of each cycle
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2024.
- Derived from this study: PubMed 36604127Lang N, Diciola A, Labidi-Galy I, Ris F, Di Marco M, Mach N, Petignat P, Toso C, Undurraga M, Hubner M. Nab-PIPAC: a phase IB study protocol of intraperitoneal cisplatin and nab-paclitaxel administered by pressurised intraperitoneal aerosol chemotherapy (PIPAC) in the treatment of advanced malignancies confined to the peritoneal cavity. BMJ Open. 2023 Jan 5;13(1):e067691. doi: 10.1136/bmjopen-2022-067691.
- Individual participant dataSharing planned: Yes. The only clinical data available to researchers will be anonymised. Requests may be directed to Sponsor Investigator or designee. The informed consent form and clinical study report will be made available
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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.
Intidhar Labidi-Galy, MD, PhD principal investigator
University Hospital, Geneva
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Nab paclitaxel and Cisplatin in people with Peritoneal Carcinomatosis, run by University Hospital, Geneva at 2 sites in Switzerland.
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 8 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 24 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. 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?
Results are not available in the source record.
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?
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). 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 NCT04000906, which also lists 1 linked publication.
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 24 May 2024.