A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.

Metastatic Pancreatic Ductal Adenocarcinoma Clinical Trial

Official title:

A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04523987
• Other study ID #: PA02/07/18
• Status: Recruiting
• Phase: Phase 1
• Start date: February 22, 2019
• Est. completion date: February 2024

Study information

• Verified date: February 2020
• Source: National University Hospital, Singapore
• Contact: Cheng Ean Chee
• Phone: 6779 5555
• Email: cheng_ean_chee[@]nuhs.edu.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a single-center, pilot study evaluating the addition of Ciprofloxacin (study drug) to standard-of-care gemcitabine and nab-paclitaxel chemotherapy in treatment-naïve metastatic PDAC patients. Patients who are recommended gemcitabine and nab-paclitaxel chemotherapy as a standard-of-care by their treating physician will be offered to participate in this study.

Description:

Oral ciprofloxacin (study drug) will be administered twice a day throughout each 28-day cycle of gemcitabine and nab-paclitaxel chemotherapy. The patient will start taking ciprofloxacin from the evening of day 1 of chemotherapy and end on the morning of day 29 of each cycle.

Ciprofloxacin tablets should be taken in the morning and evening at about the same time each day. Swallow the tablet whole. Do not split, crush or chew the tablet. Ciprofloxacin can be taken with or without food

With each study visit, the physician will prescribe 1-month supply of oral ciprofloxacin to be taken home and self-administered by the patient. The physician will have to indicate "pancreatic cancer microbiome study" on the remarks column for each cycle oral ciprofloxacin is ordered.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2024
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

• Signed informed consent. Written informed consent must be obtained prior to performing any study-related procedures.

• Age = 21 years

• Histologically or cytologically confirmed, treatment-naïve, locally advanced or metastatic pancreatic adenocarcinoma planned to commence on gemcitabine and nab-paclitaxel chemotherapy.

• Patient must have measurable disease as defined by the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v 1.1 guidelines)

• Life expectancy >3 months

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

• CrCl = 30 ml/min

Exclusion Criteria:

• Known hypersensitivity or allergy to ciprofloxacin or other quinolones

• On tizanidine or theophylline and unable to stop these medication

• Known QTc prolongation (QTc >500 msec) or torsade de pointes

• Presence of Clostridium difficile-associated diarrhea or colitis

• Known history of myasthenia gravis

• Known G6PD deficiency

Related Conditions & MeSH terms

• Adenocarcinoma
• Metastatic Pancreatic Ductal Adenocarcinoma

Intervention

Drug:
• Ciprofloxacin
Subjects enrolled will be administered oral ciprofloxacin twice a day throughout the course of each 28-day cycle of gemcitabine and nab-paclitaxel chemotherapy.

Locations

Country	Name	City	State
Singapore	National University Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (2)

Ertz-Archambault N, Keim P, Von Hoff D. Microbiome and pancreatic cancer: A comprehensive topic review of literature. World J Gastroenterol. 2017 Mar 14;23(10):1899-1908. doi: 10.3748/wjg.v23.i10.1899. Review. — View Citation

Farrell JJ, Zhang L, Zhou H, Chia D, Elashoff D, Akin D, Paster BJ, Joshipura K, Wong DT. Variations of oral microbiota are associated with pancreatic diseases including pancreatic cancer. Gut. 2012 Apr;61(4):582-8. doi: 10.1136/gutjnl-2011-300784. Epub 2 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antitumor Effect - Solid Tumors	Patients are be re-evaluated for response every 8-12 weeks (±10 days), per standard-of-care.; Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) guideline (version 1.1). Changes in the largest diameter (unidimensional measurement) of the tumor lesions and the shortest diameter in the case of malignant lymph nodes are used in RECIST.	4 years