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

Phase 1

• Conditions: Metastatic Pancreatic Ductal Adenocarcinoma
• Interventions: Drug: Ciprofloxacin

• Registration Number: NCT04523987
• Lead Sponsor: National University Hospital, Singapore

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.

Study Timeline

• Study Start: 2019-02-22
• Status Verified: 2020-02
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Study First Posted: 2020-08-24
• Last Update Posted: 2020-08-24
• Primary Completion: 2023-02
• Study Completion: 2024-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
gemcitabine and nab-paclitaxel chemotherapy	Ciprofloxacin	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.

Primary Outcome Measures

Name	Time	Method
Antitumor Effect - Solid Tumors	4 years	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.

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore