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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-22

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Metastatic Pancreatic Ductal Adenocarcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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gemcitabine and nab-paclitaxel chemotherapy

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.

Group Type EXPERIMENTAL

Ciprofloxacin

Intervention Type 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.

Interventions

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Ciprofloxacin

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No