PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis (NCT04000906) | Clinical Trial Compass
Active — Not RecruitingPhase 1
PIPAC With Nab-paclitaxel and Cisplatin in Peritoneal Carcinomatosis
Switzerland18 participantsStarted 2020-11-11
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Determine the maximal tolerated dose (MTD) of Nab paclitaxel (Abraxane®) administered IP by PIPAC in concomitance with cisplatin.
Timeframe: From the time of treatment randomization through 30 days following cessation of treatment