Combination Chemotherapy With or Without Vismodegib in Treating Patients With Advanced Stomach Cancer or Gastroesophageal Junction Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00982592
First received: September 22, 2009
Last updated: December 16, 2015
Last verified: August 2015
Results First Received: December 16, 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 Gastroesophageal Junction
Adenocarcinoma of the Stomach
Recurrent Gastric Cancer
Stage IIIA Gastric Cancer
Stage IIIB Gastric Cancer
Stage IIIC Gastric Cancer
Stage IV Gastric Cancer
Interventions: Drug: oxaliplatin
Drug: leucovorin calcium
Drug: fluorouracil
Other: placebo
Drug: vismodegib
Other: laboratory biomarker analysis

  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
From October 2009 to February 2012, 124 patients were enrolled from multi sites to this study.

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
Arm I (FOLFOX Regimen and Placebo) Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Arm II (FOLFOX Regimen and Vismodegib) Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.

Participant Flow:   Overall Study
    Arm I (FOLFOX Regimen and Placebo)     Arm II (FOLFOX Regimen and Vismodegib)  
STARTED     64     60  
Treatment Received     63     52  
COMPLETED     33 [1]   27 [1]
NOT COMPLETED     31     33  
[1] patients who were off treatment due to disease progression



  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 the patients enrolled to the study

Reporting Groups
  Description
Arm I (FOLFOX Regimen and Placebo) Patients receive FOLFOX chemotherapy comprising oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil bolus and then IV over 46-48 hours on day 1. Patients also receive placebo PO QD on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Arm II (FOLFOX Regimen and Vismodegib) Patients receive FOLFOX chemotherapy as in arm I. Patients also receive vismodegib PO on days 1-14. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
Total Total of all reporting groups

Baseline Measures
    Arm I (FOLFOX Regimen and Placebo)     Arm II (FOLFOX Regimen and Vismodegib)     Total  
Number of Participants  
[units: participants]
  64     60     124  
Age  
[units: years]
Median (Full Range)
  61.5   (25 to 77)     57.5   (29 to 74)     60   (25 to 77)  
Gender  
[units: participants]
     
Female     11     21     32  
Male     53     39     92  
Race/Ethnicity, Customized  
[units: participants]
     
Caucasian     50     42     92  
Asian     3     6     9  
African American     6     4     10  
Hispanic     4     8     12  
Nor reported     1     0     1  
Region of Enrollment  
[units: participants]
     
United States     64     60     124  



  Outcome Measures
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1.  Primary:   Median Progression-free Survival (PFS)   [ Time Frame: up to 4 years ]

2.  Secondary:   Objective Response Rate   [ Time Frame: Up to 4 years ]

3.  Secondary:   Overall Survival   [ Time Frame: up to 4 years ]

4.  Secondary:   Incidence of Toxicities (Grade 3 and Higher)   [ Time Frame: Up to 4 years ]

5.  Secondary:   Incidence of Toxicities (grades1 and 2)   [ Time Frame: Up to 4 years ]


  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: Deirdre Cohen, MD
Organization: Perlmutter Cancer Center at NYU Langone
phone: 212-731-5656
e-mail: deirdre.cohen@nyumc.org



Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00982592     History of Changes
Other Study ID Numbers: NCI-2011-01425
NCI-2011-01425 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
09-0356
CDR0000655339
NYU 09-0356 ( Other Identifier: New York University Langone Medical Center )
8376 ( Other Identifier: CTEP )
N01CM00038 ( US NIH Grant/Contract Award Number )
N01CM00071 ( US NIH Grant/Contract Award Number )
P30CA016087 ( US NIH Grant/Contract Award Number )
N01CM00070 ( US NIH Grant/Contract Award Number )
Study First Received: September 22, 2009
Results First Received: December 16, 2015
Last Updated: December 16, 2015
Health Authority: United States: Food and Drug Administration