Clinical trial NCT04523987: A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
Official title: A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
Keywords: Ciprofloxacin
Gemcitabine
Nab-Paclitaxel Chemotherapy
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
First posted: 2020-08-24
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Antitumor Effect - Solid Tumors
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital
Study officials:
affiliation: cheng_ean_chee@nuhs.edu.sg
name: Cheng Ean Chee
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 2011 Oct 12.