PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis

NCT ID: NCT04000906

Last Updated: 2024-05-24

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-11
• Study Completion Date: 2024-12-31

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.

Conditions

Peritoneal Carcinomatosis

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental Arm

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

Group Type: EXPERIMENTAL

Nab paclitaxel

Intervention Type: 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)

Cisplatin

Intervention Type: DRUG

10.5 mg/m2

Interventions

Nab paclitaxel

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

Intervention Type: DRUG

Cisplatin

10.5 mg/m2

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Intidhar Labidi-Galy, MD, PhD

Staff Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Intidhar Labidi-Galy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

University Hospital, Lausanne

Lausanne, Canton of Vaud, Switzerland

University Hospital, Geneva

Geneva, , Switzerland

Countries

Switzerland

References

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.

Reference Type: DERIVED

PMID: 36604127 (View on PubMed)

Other Identifiers

2018-01327-Nab-PIPAC

Identifier Type: -

Identifier Source: org_study_id