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Trametinib or Combination Chemotherapy in Treating Patients With Refractory or Advanced Biliary or Gallbladder Cancer or That Cannot Be Removed by Surgery (S1310)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT02042443
First received: January 20, 2014
Last updated: August 11, 2017
Last verified: August 2017
Results First Received: July 12, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Adult Cholangiocarcinoma
Advanced Adult Hepatocellular Carcinoma
BCLC Stage C Adult Hepatocellular Carcinoma
BCLC Stage D Adult Hepatocellular Carcinoma
Hilar Cholangiocarcinoma
Localized Non-Resectable Adult Liver Carcinoma
Recurrent Adult Liver Carcinoma
Recurrent Childhood Liver Cancer
Recurrent Extrahepatic Bile Duct Carcinoma
Recurrent Gallbladder Carcinoma
Stage II Gallbladder Cancer
Stage III Childhood Hepatocellular Carcinoma
Stage IIIA Gallbladder Cancer
Stage IIIB Gallbladder Cancer
Stage IV Childhood Hepatocellular Carcinoma
Stage IV Distal Bile Duct Cancer
Stage IVA Gallbladder Cancer
Stage IVB Gallbladder Cancer
Unresectable Extrahepatic Bile Duct Carcinoma
Interventions: Drug: Capecitabine
Drug: Fluorouracil
Other: Laboratory Biomarker Analysis
Drug: Leucovorin Calcium
Drug: Trametinib

  Participant Flow
  Hide 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
Trametinib Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Chemotherapy Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Participant Flow:   Overall Study
    Trametinib   Chemotherapy
STARTED   27   26 
Eligible and Analyzable   24   20 
COMPLETED   0   0 
NOT COMPLETED   27   26 
Adverse Event                2                1 
Withdrawal by Subject                0                1 
Progression                21                17 
not protocol specified                1                1 
Not eligible/not analyzable                3                6 



  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.
All eligible and analyzable patients are included.

Reporting Groups
  Description
Trametinib Patients receive trametinib PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Chemotherapy Patients receive either A) leucovorin calcium IV over 2 hours and fluorouracil IV continuously over 46-48 hours on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity or B) capecitabine PO BID on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Total Total of all reporting groups

Baseline Measures
   Trametinib   Chemotherapy   Total 
Overall Participants Analyzed 
[Units: Participants]
 24   20   44 
Age 
[Units: Years]
Median (Full Range)
 63 
 (40 to 78) 
 61 
 (41 to 81) 
 62 
 (40 to 81) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      18  75.0%      11  55.0%      29  65.9% 
Male      6  25.0%      9  45.0%      15  34.1% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      3  12.5%      1   5.0%      4   9.1% 
Not Hispanic or Latino      20  83.3%      19  95.0%      39  88.6% 
Unknown or Not Reported      1   4.2%      0   0.0%      1   2.3% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      2   8.3%      3  15.0%      5  11.4% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      5  20.8%      2  10.0%      7  15.9% 
White      16  66.7%      15  75.0%      31  70.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   4.2%      0   0.0%      1   2.3% 
Planned Chemotherapy 
[Units: Participants]
Count of Participants
     
5FU/LV   7   6   13 
Capecitabine   17   14   31 
Site of Disease 
[Units: Participants]
Count of Participants
     
Cholangiocarcinoma   19   15   34 
Gall bladder   5   5   10 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival   [ Time Frame: Up to 2 years from registration ]

2.  Secondary:   Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug   [ Time Frame: Up to 2 years ]

3.  Secondary:   Objective Response Rate   [ Time Frame: Up to 2 years from registration ]

4.  Secondary:   Progression-free Survival   [ Time Frame: Up to 2 years from registration ]


  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
No text entered.


  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: SWOG Statistician
Organization: SWOG Statistics & Data Management Center
phone: 206-667-4408



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT02042443     History of Changes
Other Study ID Numbers: NCI-2013-02485
NCI-2013-02485 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
S1310
SWOG-S1310
S1310 ( Other Identifier: SWOG )
S1310 ( Other Identifier: CTEP )
U10CA180888 ( U.S. NIH Grant/Contract )
U10CA032102 ( U.S. NIH Grant/Contract )
Study First Received: January 20, 2014
Results First Received: July 12, 2017
Last Updated: August 11, 2017