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Trial record 11 of 11 for:    "Multiple endocrine neoplasia type 1"

Capecitabine and Temozolomide for Neuroendocrine Cancers

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ClinicalTrials.gov Identifier: NCT00869050
Recruitment Status : Completed
First Posted : March 25, 2009
Results First Posted : June 22, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Columbia University

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Neuroendocrine Tumors
Interventions: Drug: Capecitabine
Drug: Temozolomide

  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
Capecitabine and Temozolomide

Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).

Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles

After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.

Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).

Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles

After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.


Participant Flow:   Overall Study
    Capecitabine and Temozolomide
STARTED   41 
COMPLETED   38 
NOT COMPLETED   3 
Screen Failure                3 



  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.
No text entered.

Reporting Groups
  Description
Capecitabine and Temozolomide

Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg and Temozolomide 150-200 mg/m2/day (PO divided BID).

Capecitabine: Capecitabine 1500 mg/m2/day (PO divided BID) with a maximum daily dose of 2500mg Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles

After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.

Temozolomide: Temozolomide 150-200 mg/m2/day (PO divided BID).

Two week treatment regimen followed by two weeks off treatment, repeated for 12 cycles

After patients have completed 12 cycles with no signs of progression of disease, radiologic evaluation (CT or MRI) will be done after three cycles. This will result in two 28 day cycles and one 35 day cycle.


Baseline Measures
   Capecitabine and Temozolomide 
Overall Participants Analyzed 
[Units: Participants]
 41 
Age, Customized 
[Units: Participants]
 
Between 30 and 39 years   2 
Between 40 and 49 years   6 
Between 50 and 59 years   22 
Between 60 and 69 years   9 
Between 70 and 79 years   1 
Between 80 and 89 years   1 
Gender 
[Units: Participants]
 
Female   25 
Male   16 
Ethnicity (NIH/OMB) 
[Units: Participants]
 
Hispanic or Latino   2 
Not Hispanic or Latino   33 
Unknown or Not Reported   6 
Race (NIH/OMB) 
[Units: Participants]
 
American Indian or Alaska Native   0 
Asian   1 
Native Hawaiian or Other Pacific Islander   0 
Black or African American   2 
White   30 
More than one race   1 
Unknown or Not Reported   7 
Region of Enrollment 
[Units: Participants]
 
United States   41 


  Outcome Measures

1.  Primary:   Number of Participants With Partial Response (PR)   [ Time Frame: 12 months ]

2.  Primary:   Number of Participants With Complete Response (CR)   [ Time Frame: 12 months ]


  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: Dr. Paul Oberstein
Organization: Columbia University
phone: 212-305-0592
e-mail: po2178@cumc.columbia.edu



Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00869050     History of Changes
Other Study ID Numbers: AAAP4117
First Submitted: March 23, 2009
First Posted: March 25, 2009
Results First Submitted: May 3, 2016
Results First Posted: June 22, 2016
Last Update Posted: July 25, 2016