Pancreatic cancer with peritoneal metastases MedDRA version: 21.1 Level: PT Classification code 10059326 Term: Pancreatic carcinoma stage IV System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: Abraxane
Product Code: [Abraxane]
Pharmaceutical Form: Powder for suspension for injection
INN or Proposed INN: NAB PACLITAXEL
CAS Number: 33069-62-4
Current Sponsor code: 33069-62-4
Con
Sponsors
FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¿ Age = 18 years; ¿ Willing and able to provide written and informed consent; ¿ Histological or cytological proof of pancreatic cancer; ¿ Metastatic disease with peritoneal carcinomatosis determined by the treating physician, based on abdominal CT or MR and/or diagnostic laparotomy or laparoscopy; ¿ Evaluable disease defined by RECIST 1.1 criteria ¿ Eastern Cooperative Oncology Group (ECOG) performance status =2; ¿ Life expectancy of at least 3 months; ¿ No contraindication for laparoscopy; ¿ No contraindication for drugs used in the study; ¿ Adequate bone marrow function: Absolute neutrophil count = 1500 cell./mm3; Platelets = 100000 cell./mm3; ¿ Hemoglobin = 9 g/dl ¿ Adequate renal function (serum creatinine up to 1.5 times the maximal limit of the local laboratory) or else based upon clinical evaluation; ¿ Resolution of all toxic effects of prior therapies or surgical procedures to Grade = 1 (except alopecia and peripheral neuropathy); ¿ In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 x the upper limit of normal (ULN). If the patient has liver metastases, ALT and AST should be =65 years) yes F.1.3.1 Number of subjects for this age range 12
Exclusion criteria
Exclusion criteria: ¿ Advanced metastatic systemic disease with clinical deterioration; ¿ Symptoms of gastrointestinal occlusion and total parenteral nutritional support; ¿ Patients defined as “refractory” to previous systemic treatment with Nab-paclitaxel and Gemcitabine administered for locally advanced pancreatic cancer (patients treated with Nabpaclitaxel-Gemcitabine for a locally advanced disease may be included if PM developed after at least 6 months from the end of previous chemotherapy); ¿ History of severe and unexpected reactions to Nabpaclitaxel or Gemcitabine derivates? ¿ Known hypersensitivity reaction to drugs chemically related to Nabpaclitaxel, Gemcitabine and their excipients; ¿ Severe cardiac disease (recent myocardial ischemia, severe cardiac arrhythmias, severe cardiac failure); ¿ Clinical disease progression after first 2 months of systemic Nabpaclitaxel Gemcitabine chemotherapy; ¿ Any concurrent severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk of associated with study participation or investigational product administration or may interfere with compliance with study procedures or the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into the study; ¿ Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive beta-hCG laboratory test; ¿ Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and through 120 days after the last dose of study drug. Highly effective contraception methods include: Total abstinence (when this is in line with the preferred and usual lifestyle of the Subject). Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Tubal ligation at least six weeks before taking study treatment. Male sterilization (at least 6 months prior to screening). For female subjects on the study, the vasectomized male partner should be the sole partner for that subject. Combination of the following: Placement of an intrauterine device (IUD) or intrauterine system (IUS); Barrier methods of contraception: Condom or Occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/ vaginal suppository.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the anti-tumoral activity of combined Nabpaclitaxel-PIPAC and systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases.;Secondary Objective: Secondary objectives include the evaluation of the feasibility, the safety, further assessment of the antitumoral activity, the overall and progression free survival, the QoL, the pharmacokinetics of Nabpaclitaxel PIPAC. Furthermore, the study aims to evaluate the patients’ nutritional status and the molecular evolution of PM along treatment with a time-course translational research.;Primary end point(s): Primary endpoint: The Disease Control Rate (DCR) defined as the combined incidence of complete response (CR), partial response (PR) and stable disease (SD) for = 16 weeks measured according to the RECIST v. 1.1 criteria during study treatments and the EOT visit.;Timepoint(s) of evaluation of this end point: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: 3 years;Secondary end point(s): - The compliance to treatment will be assessed through the following endpoints: - The number of patients unable to undergo six cycles of systemic chemotherapy combined with three PIPAC cycles and reasons for discontinuation - The number of patients who discontinued or postponed beyond 10 days the scheduled standard systemic chemotherapy after each PIPAC cycle. - The number of patients that reduce the dose of systemic chemotherapy during the study; - The number of patients that reduce the dose of PIPAC drug during the study; - The safety and toxicity will be assessed through the following endpoints: - The number of patients with major toxicity, defined as grade =3 according to Common Terminology Criteria for Adverse Events (CTCAE) V5.0 during the on-study evaluation phase and up to 4 weeks after the last chemotherapy cycleadministration (around 8 months). - The number of patients with minor toxicity, defined as grade =2 according to CTCAE v5.0 during the treatment period and up to 4 weeks after the last combined coursechemotherapy administration. - The number of patients with major and minor postoperative complications, defined as grade =3 and grade =2 according to Clavien-Dindo, respectively, during the treatment period and up to 4 weeks after the last PIPAC procedure. - The procedures-related characteristics of PIPAC (eg, intraoperative complications, amount of adhesions, procedure-related mistakes and difficulties, operating time). - The hospital stay, defined as the number of days between PIPAC and initial discharge. - The number of readmissions, defined as any hospital admission after discharge, up to 4 weeks after the last PIPAC procedure. - The antitumoral activity of the proposed treatment will be assessed also through: - The pathological tumor response, based on review of peritoneal biopsies collected during each PIPAC, performed by a pathologist blinded to clinical outcomes | — |
Countries
Italy
Contacts
Public ContactDIREZIONE SCIENTIFICA
MARGHERITA ZONA
Outcome results
None listed