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Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01823679
Recruitment Status : Terminated (Low accrual)
First Posted : April 4, 2013
Results First Posted : March 10, 2017
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
A. Dimitrios Colevas, Stanford University

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Squamous Cell Carcinoma of the Skin
Recurrent Skin Cancer
Intervention Drug: Capecitabine
Enrollment 2
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Capecitabine 1000 mg/m²
Hide Arm/Group Description Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
Period Title: Overall Study
Started 2
Completed 1
Not Completed 1
Reason Not Completed
Death             1
Arm/Group Title Capecitabine 1000 mg/m²
Hide Arm/Group Description Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
Overall Number of Baseline Participants 2
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
<=18 years
0
   0.0%
Between 18 and 65 years
1
  50.0%
>=65 years
1
  50.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Female
0
   0.0%
Male
2
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
Hispanic or Latino
1
  50.0%
Not Hispanic or Latino
1
  50.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
2
 100.0%
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time Frame 9 weeks (3 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine 1000 mg/m²
Hide Arm/Group Description:

Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given orally (PO)

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of participants
0
2.Secondary Outcome
Title Progression-free Survival (PFS) at 1 Year
Hide Description Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine 1000 mg/m2
Hide Arm/Group Description:

Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given orally (PO)

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of participants
50
3.Secondary Outcome
Title Progression-free Survival (PFS) at 2 Years
Hide Description Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine 1000 mg/m2
Hide Arm/Group Description:

Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given orally (PO)

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of participants
0
4.Secondary Outcome
Title Overall Survival (OS) at 1 Year
Hide Description Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine 1000 mg/m2
Hide Arm/Group Description:

Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given orally (PO)

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of participants
50
5.Secondary Outcome
Title Overall Survival (OS) at 2 Years
Hide Description Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Capecitabine 1000 mg/m2
Hide Arm/Group Description:

Participants will receive oral capecitabine twice-a-day (BID) as 500 mg/m2 doses on days 1 to 14.

Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Capecitabine: Given orally (PO)

Overall Number of Participants Analyzed 2
Measure Type: Number
Unit of Measure: percentage of participants
0
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capecitabine 1000 mg/m²
Hide Arm/Group Description Participants are to receive 500 mg/m² of capecitabine orally (PO) twice daily (BID) on days 1 to 14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 2 years.
All-Cause Mortality
Capecitabine 1000 mg/m²
Affected / at Risk (%)
Total   1/2 (50.00%)    
Hide Serious Adverse Events
Capecitabine 1000 mg/m²
Affected / at Risk (%) # Events
Total   1/2 (50.00%)    
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Progressive disease * [1]  1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Progressive Disease
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Capecitabine 1000 mg/m²
Affected / at Risk (%) # Events
Total   2/2 (100.00%)    
Blood and lymphatic system disorders   
Hypertension *  1/2 (50.00%)  1
Hemoglobin *  1/2 (50.00%)  1
Cardiac disorders   
Heart Burn *  1/2 (50.00%)  1
Gastrointestinal disorders   
Dysguesia *  1/2 (50.00%)  1
General disorders   
Fatigue *  1/2 (50.00%)  1
Nausea *  1/2 (50.00%)  1
Weight Loss *  1/2 (50.00%)  1
Rash *  1/2 (50.00%)  1
Infections and infestations   
Hand and Foot Syndrome *  1/2 (50.00%)  1
Musculoskeletal and connective tissue disorders   
Hand Cramping *  1/2 (50.00%)  1
Renal and urinary disorders   
AST increase *  1/2 (50.00%)  1
Alk P'Tase increase *  1/2 (50.00%)  1
Skin and subcutaneous tissue disorders   
Hyperpigmentation *  1/2 (50.00%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alexander Dimitrios Colevas, MD
Organization: Stanford University Medical Center
Phone: 650-724-9707
EMail: colevas@stanford.edu
Layout table for additonal information
Responsible Party: A. Dimitrios Colevas, Stanford University
ClinicalTrials.gov Identifier: NCT01823679    
Other Study ID Numbers: IRB-26699
NCI-2013-00710 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SKIN0016 ( Other Identifier: OnCore )
First Submitted: March 29, 2013
First Posted: April 4, 2013
Results First Submitted: January 20, 2017
Results First Posted: March 10, 2017
Last Update Posted: April 12, 2018