Back to resultsA Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
Primary Purpose
Metastatic Pancreatic Ductal Adenocarcinoma
Status
Recruiting
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
Ciprofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Ductal Adenocarcinoma focused on measuring Ciprofloxacin, Gemcitabine, Nab-Paclitaxel Chemotherapy
Eligibility 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
Sites / Locations
- National University HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
gemcitabine and nab-paclitaxel chemotherapy
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04523987
First Posted
August 19, 2020
Last Updated
August 19, 2020
Sponsor
National University Hospital, Singapore
1. Study Identification
Unique Protocol Identification Number
NCT04523987
Brief Title
A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
Official Title
A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2019 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Ductal Adenocarcinoma
Keywords
Ciprofloxacin, Gemcitabine, Nab-Paclitaxel Chemotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gemcitabine and nab-paclitaxel chemotherapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Intervention Description
Subjects enrolled will be administered oral ciprofloxacin twice a day throughout the course of each 28-day cycle of gemcitabine and nab-paclitaxel chemotherapy.
Primary Outcome Measure Information:
Title
Antitumor Effect - Solid Tumors
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheng Ean Chee
Phone
6779 5555
Email
cheng_ean_chee@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng Ean Chee
Organizational Affiliation
cheng_ean_chee@nuhs.edu.sg
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cheng Ean Chee
Phone
779 5555
Email
cheng_ean_chee@nuhs.edu.sg
12. IPD Sharing Statement
Citations:
PubMed Identifier
28348497
Citation
Ertz-Archambault N, Keim P, Von Hoff D. Microbiome and pancreatic cancer: A comprehensive topic review of literature. World J Gastroenterol. 2017 Mar 14;23(10):1899-1908. doi: 10.3748/wjg.v23.i10.1899.
Results Reference
result
PubMed Identifier
21994333
Citation
Farrell JJ, Zhang L, Zhou H, Chia D, Elashoff D, Akin D, Paster BJ, Joshipura K, Wong DT. Variations of oral microbiota are associated with pancreatic diseases including pancreatic cancer. Gut. 2012 Apr;61(4):582-8. doi: 10.1136/gutjnl-2011-300784. Epub 2011 Oct 12.
Results Reference
result
Learn more about this trial
A Pilot Study of Ciprofloxacin Plus Gemcitabine and Nab-Paclitaxel Chemotherapy in Patients With Metastatic Pancreatic Ductal Adenocarcinoma.
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