Overview

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

Status:
Recruiting
Trial end date:
2024-02-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
National University Hospital, Singapore
Treatments:
Ciprofloxacin
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