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

NCT04523987 | Active Not Recruiting Phase 1

• 1 other identifier: PA02/07/18
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Keywords

Ciprofloxacin; Gemcitabine; Nab-Paclitaxel Chemotherapy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

gemcitabine and nab-paclitaxel chemotherapy

EXPERIMENTAL

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.

Drug: Ciprofloxacin

Interventions

Ciprofloxacin DRUG

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

gemcitabine and nab-paclitaxel chemotherapy

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital

Singapore, Singapore

Location

Related 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.

  PMID: 28348497 BACKGROUND

• 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.

  PMID: 21994333 BACKGROUND

MeSH Terms

Interventions

Ciprofloxacin

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Cheng Ean Chee

  cheng_ean_chee@nuhs.edu.sg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 24, 2020
• Study Start: February 22, 2019
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: September 25, 2025

Record last verified: 2025-09

Locations

SG (1)