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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
Enrollment 41

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Capecitabine and Temozolomide
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 41
Completed 38
Not Completed 3
Reason Not Completed
Screen Failure             3
Arm/Group Title Capecitabine and Temozolomide
Hide Arm/Group Description

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.

Overall Number of Baseline Participants 41
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 41 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
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Female
25
  61.0%
Male
16
  39.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
Hispanic or Latino
2
   4.9%
Not Hispanic or Latino
33
  80.5%
Unknown or Not Reported
6
  14.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 41 participants
American Indian or Alaska Native
0
   0.0%
Asian
1
   2.4%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
2
   4.9%
White
30
  73.2%
More than one race
1
   2.4%
Unknown or Not Reported
7
  17.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 41 participants
41
1.Primary Outcome
Title Number of Participants With Partial Response (PR)
Hide Description PR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as a reduction of ≥ 30% in the sum of the longest diameter for all target lesions lasting > 4 weeks, during which no new lesions may appear, when compared with with pretreatment measurements.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
28/38 analyzed.
Arm/Group Title Capecitabine and Temozolomide
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
9
2.Primary Outcome
Title Number of Participants With Complete Response (CR)
Hide Description CR according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, which is defined as disappearance of all target lesions (primary and metastases), signs, symptoms, and biochemical changes related to the tumor for >4 weeks, during which no new lesions may appear and no existing lesion may enlarge.
Time Frame 12 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
28/38 analyzed.
Arm/Group Title Capecitabine and Temozolomide
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: participants
3
Time Frame [Not Specified]
Adverse Event Reporting Description Number at risk reflects the participants who passed the screening.
 
Arm/Group Title Capecitabine and Temozolomide
Hide Arm/Group Description

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.

All-Cause Mortality
Capecitabine and Temozolomide
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine and Temozolomide
Affected / at Risk (%) # Events
Total   4/38 (10.53%)    
General disorders   
Death * [1]  1/38 (2.63%)  1
Syncope * [2]  1/38 (2.63%)  2
Hypoglycemia * [3]  2/38 (5.26%)  3
*
Indicates events were collected by non-systematic assessment
[1]
Hospitalized prior - reason unknown
[2]
Hospitalized
[3]
1 participant - hospitalized due to vomiting and a stomach virus 1 participant - hospitalized due to seizures
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Capecitabine and Temozolomide
Affected / at Risk (%) # Events
Total   28/38 (73.68%)    
Blood and lymphatic system disorders   
Thrombocytopenia *  2/38 (5.26%)  2
Pancytopenia *  1/38 (2.63%)  1
Gastrointestinal disorders   
Pain abdomen *  2/38 (5.26%)  2
Diarrhea *  5/38 (13.16%)  5
Liver pain *  1/38 (2.63%)  1
General disorders   
Fatigue *  5/38 (13.16%)  5
Dizziness *  1/38 (2.63%)  1
Night sweats *  2/38 (5.26%)  2
Vomiting *  1/38 (2.63%)  1
Confusion *  1/38 (2.63%)  1
Loss of apetite *  2/38 (5.26%)  2
Nausea *  1/38 (2.63%)  1
Cough *  2/38 (5.26%)  2
Constipation *  4/38 (10.53%)  4
Edema *  2/38 (5.26%)  2
Mucositis *  1/38 (2.63%)  1
Tingling lower lip *  1/38 (2.63%)  1
Nausea *  4/38 (10.53%)  4
Anxiety *  1/38 (2.63%)  1
Depression *  1/38 (2.63%)  1
Pruritus *  1/38 (2.63%)  1
Immune system disorders   
Allergy to dye *  1/38 (2.63%)  1
Infections and infestations   
Infection *  5/38 (13.16%)  5
Musculoskeletal and connective tissue disorders   
Arm and ankle pain *  1/38 (2.63%)  1
Skin and subcutaneous tissue disorders   
Erythema *  1/38 (2.63%)  1
Facial flushing *  2/38 (5.26%)  2
Nail changes *  1/38 (2.63%)  1
Surgical and medical procedures   
Rash *  1/38 (2.63%)  1
*
Indicates events were collected by non-systematic assessment
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
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