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