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

  • STATUS
    Recruiting
  • End date
    Feb 25, 2024
  • participants needed
    10
  • sponsor
    National University Hospital, Singapore
Updated on 25 January 2021

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-nave 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.

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.

Details
Condition Metastatic Pancreatic Ductal Adenocarcinoma
Treatment Ciprofloxacin
Clinical Study IdentifierNCT04523987
SponsorNational University Hospital, Singapore
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

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-nave, 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

0/250

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note