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Study to Evaluate Bi-weekly Dosing of Gemcitabine Plus Nab-Paclitaxel to Treat Metastatic Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT01851174
Recruitment Status : Terminated (PI Leaving Site)
First Posted : May 10, 2013
Results First Posted : December 4, 2017
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Carcinoma Non-resectable
Stage IV Pancreatic Cancer
Interventions Drug: Gemcitabine
Drug: nab-Paclitaxel
Enrollment 15
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemcitabine and Nab-Paclitaxel
Hide Arm/Group Description

Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days

nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days

Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion

nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion

Period Title: Overall Study
Started 15
Completed 15
Not Completed 0
Arm/Group Title Gemcitabine and Nab-Paclitaxel
Hide Arm/Group Description

Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days

nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days

Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion

nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion

Overall Number of Baseline Participants 0
Hide Baseline Analysis Population Description
The information required here was not captured. The investigator(s) are no longer at the site and no additional information was left.
Age, Categorical  
Number Analyzed 0 participants
<=18 years
Between 18 and 65 years
>=65 years
Sex: Female, Male  
Number Analyzed 0 participants
Female
Male
Region of Enrollment  
Unit of measure:  Participants
United States Number Analyzed 0 participants
1.Primary Outcome
Title Overall Survival Based on Toxicity Profile of Adverse Events.
Hide Description Determine the toxicity profile (decrease in hematological and non-hematological treatment-related AE's) with bi-weekly dosing of gemcitabine plus nab-Paclitaxel
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left.
Arm/Group Title Gemcitabine and Nab-Paclitaxel
Hide Arm/Group Description:

Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days

nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days

Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion

nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Progression Free Survival Time
Hide Description Determine progression free survival time with this regimen
Time Frame One year
Hide Outcome Measure Data
Hide Analysis Population Description
The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left. Data were not collected
Arm/Group Title Gemcitabine and Nab-Paclitaxel
Hide Arm/Group Description:

Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days

nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days

Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion

nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame There is no information available that reflects this information. The information required here was not captured. The investigator(s) are no longer at the site and no additional information or instruction was left.
Adverse Event Reporting Description This information was not recorded and is not available. The investigator(s) are no longer at the site and no additional information or instruction was left.
 
Arm/Group Title Gemcitabine and Nab-Paclitaxel
Hide Arm/Group Description

Gemcitabine (1,000 mg/m^2) administered intravenously on days 1 and 15, every 28 days

nab-Paclitaxel (125 mg/m^2) administered intravenously on days 1 and 15, every 28 days

Gemcitabine: Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion

nab-Paclitaxel: Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion

All-Cause Mortality
Gemcitabine and Nab-Paclitaxel
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine and Nab-Paclitaxel
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gemcitabine and Nab-Paclitaxel
Affected / at Risk (%)
Total   0/0 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jessica L. Coats
Organization: CTCA
Phone: 6232073899
EMail: jessica.coats@ctca-hope.com
Layout table for additonal information
Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01851174     History of Changes
Other Study ID Numbers: WRMC 12-25
First Submitted: February 15, 2013
First Posted: May 10, 2013
Results First Submitted: September 27, 2017
Results First Posted: December 4, 2017
Last Update Posted: February 7, 2018