Safety and efficacy of faecal transplant and chemotherapy in the management of pancreatic cancer

Phase 1

• Conditions: non-resectable pancreatic cancer; Cancer - Pancreatic

• Registration Number: ACTRN12624000455561
• Lead Sponsor: Central Adelaide Local Health Network (CALHN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-12
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Participants who will be included are patients with a pancreatic cancer diagnosis who underwent an initial CT scan, and whose tumour is not surgically resectable at first assessment (including borderline resectable). The patients must be:

•Adults aged between 18 and 75 years of age
•Seen by a participating clinician for their first assessment between the study start date and the end of recruitment date
•Administered Folfirinox as a chemotherapy agent
•Eastern Cooperative Oncology Group Performance status (ECOG PS) of 0-1.
•Presenting an adequate bone marrow function with haemoglobin > 100 g/L, platelets > 100 X 10^9/L neutrophils > 1.5 X 10^9/L within 7 days of enrolment.
•Presenting an adequate renal function, with calculated creatinine clearance >40 mL/min (Cockcroft and Gault) within 7 days of enrolment.
•Presenting an adequate hepatic function with serum total bilirubin < 1.25 X upper limit of normal range (ULN) and alanine transaminase (ALT) or aspartate aminotransferase (AST)<2.5xULN (<5x ULN) if liver metastases present) within 7 days of enrolment
•Presenting a magnesium close to the lower limit of normal range within 7 days of enrolment.
•With a life expectancy of at least 12 weeks.
•Returning a negative pregnancy test around 72 hours before commencing study treatment (women of childbearing potential only).
•Speaking English or attending appointments accompanied with an English speaking next of kin
•Able to provide a signed informed consent
•Willing and able to comply with all study requirements, including treatment timing and nature of required assessments

Exclusion Criteria

Patients:
•Aged under 18 years old or over 75 years old at first assessment
•With resectable pancreatic tumour who are predicted to receive surgery
•Already receiving chemotherapy treatment either for pancreatic cancer or another cancer
•Who have already received chemotherapy treatment for pancreatic cancer.
•With prior pelvic radiotherapy, systemic chemotherapy, immunotherapy, approved proteins/antibodies or any investigational agent within 4 weeks prior to commencing study treatment.
•Who received radiotherapy within 14 days of commencing study treatment.
•With unresolved toxicities from prior systemic therapy or radiotherapy that, in the opinion of the investigator, does not qualify the patient for study treatment.
•Wwith medical or psychiatric conditions that compromise the patient’s ability to give informed consent or to complete the protocol.
•With prior systemic therapy, including with drugs targeting EGFR such as cetuximab, panitumumab or erlotinib
•Pregnant or breastfeeding women
•Severely immunocompromised patients (neutropenic as defined by <1,500 neutrophils cells/µL; this is to optimise the safety of FMT administration)
•With diagnosed dysphagia or other disorder affecting swallowing
•Who received prebiotic or probiotic within 4 weeks of randomisation (to exclude recent manipulation of the gut microbiota)
•Who used antibiotic within 8 weeks of randomisation (to exclude recent manipulation of the gut microbiota)
•For which the pancreatic tumour(s) were identified as a secondary cancer
•With known allergy to Creon and/ or Maxolon
•With known anaphylactic food allergy
•With a history of interstitial pneumonitis, pulmonary fibrosis or evidence of interstitial pneumonitis, or pulmonary fibrosis on baseline chest CT scan.
•With a history of Gilbert syndrome.
•With known cirrhosis, chronic active hepatitis, or chronic persistent hepatitis.
•With active bleeding diathysis.
•With uncontrolled clinically significant cardiac disease, arrhythmias or angina pectoris
•With active inflammatory bowel disease or other bowel disease causing chronic diarrhoea (defined as CTC grade 2 [CTCAE version 4.3])
•Who receive chronic treatment with immunosuppressives.
•Wth a known history of HIV seropositivity.
•Who have any severe and/or uncontrolled medical conditions or infections
•Who have a history of another primary malignant disease apart from non-melanotic skin cancer or carcinoma in situ of the uterine cervix or any other cancer treated with curative intent >2 years previously without evidence of relapse.
•Presenting brain metastasis.
•Women and partners of women of childbearing potential who are not using effective contraception. Adequate contraception must be used throughout study treatment and for 6 months following the completion of all study treatment.
•With history of serious drug adverse reactions.

Study & Design

• Study Type: Interventional
• Study Design: Not specified