Gemcitabine Hydrochloride With or Without Vismodegib in Treating Patients With Recurrent or Metastatic Pancreatic Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01064622
First received: February 5, 2010
Last updated: January 29, 2015
Last verified: March 2014
Results First Received: January 29, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Adenocarcinoma of the Pancreas
Recurrent Pancreatic Cancer
Stage IV Pancreatic Cancer
Interventions: Drug: vismodegib
Drug: gemcitabine hydrochloride
Other: hydrocortisone/placebo

  Participant Flow
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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
Prior to the phase II randomized trial, an open-label, lead-in phase I study was conducted with all patients receiving gemcitabine hydrochloride plus vismodegib. Seven patients were enrolled and no safety issues were identified.

Reporting Groups
  Description
Arm I (Gemcitabine Hydrochloride and Placebo)

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.

gemcitabine hydrochloride: Given IV

hydrocortisone/placebo: Given PO

Arm II (Gemcitabine Hydrochloride and Vismodegib)

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

vismodegib: Given PO

gemcitabine hydrochloride: Given IV


Participant Flow for 2 periods

Period 1:   Randomized Phase II
    Arm I (Gemcitabine Hydrochloride and Placebo)     Arm II (Gemcitabine Hydrochloride and Vismodegib)  
STARTED     55     56  
COMPLETED     53     53  
NOT COMPLETED     2     3  
Withdrawal by Subject                 2                 2  
Protocol Violation                 0                 1  

Period 2:   Crossover of Arm I
    Arm I (Gemcitabine Hydrochloride and Placebo)     Arm II (Gemcitabine Hydrochloride and Vismodegib)  
STARTED     22 [1]   0  
COMPLETED     22     0  
NOT COMPLETED     0     0  
[1] Among 53 patients, 45 had disease progression; however 23 elected not to crossover to vismodegib.



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
Arm I (Gemcitabine Hydrochloride and Placebo)

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and placebo PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. At the time of disease progression, patients are unblinded and may crossover to arm II.

gemcitabine hydrochloride: Given IV

hydrocortisone/placebo: Given PO

Arm II (Gemcitabine Hydrochloride and Vismodegib)

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15 and vismodegib PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

vismodegib: Given PO

gemcitabine hydrochloride: Given IV

Total Total of all reporting groups

Baseline Measures
    Arm I (Gemcitabine Hydrochloride and Placebo)     Arm II (Gemcitabine Hydrochloride and Vismodegib)     Total  
Number of Participants  
[units: participants]
  53     53     106  
Age [1]
[units: years]
Mean (Full Range)
  64.5    (39 to 84)     64.7    (49 to 82)     64.6    (39 to 84)  
Gender  
[units: participants]
     
Female     26     22     48  
Male     27     31     58  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     1     1  
Asian     0     1     1  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     6     10     16  
White     45     40     85  
More than one race     0     0     0  
Unknown or Not Reported     2     1     3  
[1] One age value missing from Arm I.



  Outcome Measures
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1.  Primary:   Progression-free Survival   [ Time Frame: Up to 3 years ]

2.  Secondary:   Overall Survival   [ Time Frame: Up to 3 years ]

3.  Secondary:   Objective Response Rate   [ Time Frame: Up to 6 months ]

4.  Secondary:   Incidence of Adverse Events   [ Time Frame: Up to 3 years ]

5.  Secondary:   Activity (Overall Response Rate) in Crossover Patients   [ Time Frame: Up to 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Hedy Kindler, MD
Organization: University of Chicago
phone: 773-702-0360
e-mail: hkindler@medicine.bsd.uchicago.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01064622     History of Changes
Other Study ID Numbers: NCI-2011-01454, NCI-2011-01454, 8418, UCCRC-8418, CDR0000655378, 09-068, 8418, N01CM00071, P30CA014599, N01CM00038
Study First Received: February 5, 2010
Results First Received: January 29, 2015
Last Updated: January 29, 2015
Health Authority: United States: Food and Drug Administration