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

Phase 1Active Not RecruitingNCT04523987

National University Hospital, Singapore10 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Pancreatic Ductal Adenocarcinoma

Interventions

CiprofloxacinDRUG

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

National University Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

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.

Time frame: 4 years

Data from ClinicalTrials.gov

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