PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis

NCT04000906 | Active Not Recruiting Phase 1

• 1 other identifier: 2018-01327-Nab-PIPAC
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Peritoneal Carcinomatosis

Keywords

pancreatic cancer; oeso-gastric cancer; epithelial ovarian cancer; primitive peritoneal mesothelioma

Outcome Measures

Primary Outcomes (1)

• 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.

  From the time of treatment randomization through 30 days following cessation of treatment

Secondary Outcomes (3)

• Adverse events (AE) and serious adverse events (SAE)

  D-1/D10 of each cycle

• The efficacy

  D0 of each cycle

• The QoL

  D-1/D10 of each cycle

Study Arms (1)

Experimental Arm

EXPERIMENTAL

Pressurized intraperitoneal aerosol chemotherapy (PIPAC) administration of Nab paclitaxel and cisplatin

Drug: Nab paclitaxel; Drug: Cisplatin

Interventions

Nab paclitaxel DRUG

Dose escalation (7.5 mg/m2, 15 mg/m2, 25 mg/m2, 37.5 mg/m2, 52.5 mg/m2 and 70 mg/m2)

Experimental Arm

Cisplatin DRUG

10.5 mg/m2

Experimental Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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,
• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (2)

University Hospital, Lausanne

Lausanne, Canton of Vaud, 1011, Switzerland

Location

University Hospital, Geneva

Geneva, 1211, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 36604127 DERIVED

MeSH Terms

Conditions

Peritoneal Neoplasms; Pancreatic Neoplasms; Carcinoma, Ovarian Epithelial

Interventions

Taxes; Cisplatin

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Endocrine Gland Neoplasms; Pancreatic Diseases; Endocrine System Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Ovarian Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Intidhar Labidi-Galy, MD, PhD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 27, 2019
• Study Start: November 11, 2020
• Primary Completion: December 12, 2023
• Study Completion: December 1, 2024
• Last Updated: May 24, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: All data supporting the findings of the current study will be made available from the corresponding author upon reasonable request.

Locations

CH (2)