Combined Nabpaclitaxel Pressurized IntraPeritoneal Aerosol Chemotherapy and systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases. A single-arm, open-label, phase II trial. Nab-PIPAC Trial
- Conditions
- Pancreatic cancer with peritoneal metastasesMedDRA version: 21.1Level: PTClassification code 10059326Term: Pancreatic carcinoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2021-002539-51-IT
- Lead Sponsor
- FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 38
¿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 < 5 x ULN
¿Total bilirubin = ULN, or total bilirubin 1.5 x ULN with direct bilirubin = ULN of the laboratory in subjects with documented Gilbert's Syndrome
¿If screening assessments are abnormal, chemistry assessments may be repeated up to two times; subjects may receive appropriate supplementation prior to re-assessment.
¿Confirmed negative serum pregnancy test (beta-hCG) within 72 hours before starting study treatment for patients with pre- or peri-menopausal status.
Male subject must, even if surgically sterilized (ie, status post-vasectomy): Agree to practice highly effective barrier contraception (use condoms) during the entire study treatment period and through 120 days after the last dose of study drugs. For subjects (who have not undergone vasectomy) with female partners of childbearing potential, the subject and his partner must in addition to condoms, use highly effective contraceptive measures when engaging in sexual intercourse throughout the study, and for at least 120 days after the last dose of study drugs (eg, oral contraceptive and condoms, intrauterine device
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 26
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
¿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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the anti-tumoral activity of combined Nabpaclitaxel-PIPAC and systemic Nabpaclitaxel-Gemcitabine chemotherapy for pancreatic cancer peritoneal metastases.;Primary end point(s): Primary endpoint:<br>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.;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.;Timepoint(s) of evaluation of this end point: 12 months
- Secondary Outcome Measures
Name Time Method