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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Gemcitabine and Nab-Paclitaxel

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


Participant Flow:   Overall Study
    Gemcitabine and Nab-Paclitaxel
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The information required here was not captured. The investigator(s) are no longer at the site and no additional information was left.

Reporting Groups
  Description
Gemcitabine and Nab-Paclitaxel

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


Baseline Measures
   Gemcitabine and Nab-Paclitaxel 
Overall Participants Analyzed 
[Units: Participants]
 0 


  Outcome Measures

1.  Primary:   Overall Survival Based on Toxicity Profile of Adverse Events.   [ Time Frame: One year ]

2.  Secondary:   Progression Free Survival Time   [ Time Frame: One year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jessica L. Coats
Organization: CTCA
phone: 6232073899
e-mail: jessica.coats@ctca-hope.com



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