Trial Outcomes & Findings for Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin (NCT NCT01823679)
NCT ID: NCT01823679
Last Updated: 2018-04-12
Results Overview
Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
2 participants
Primary outcome timeframe
9 weeks (3 cycles)
Results posted on
2018-04-12
Participant Flow
Participant milestones
| Measure |
Capecitabine 1000 mg/m²
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 Study
STARTED
|
2
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Capecitabine 1000 mg/m²
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 Study
Death
|
1
|
Baseline Characteristics
Capecitabine in Treating Patients With Advanced or Recurrent Squamous Cell Carcinoma of the Skin
Baseline characteristics by cohort
| Measure |
Capecitabine 1000 mg/m²
n=2 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 9 weeks (3 cycles)Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Outcome measures
| Measure |
Capecitabine 1000 mg/m²
n=2 Participants
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)
|
|---|---|
|
Objective Response Rate (ORR)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearProportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Capecitabine 1000 mg/m²
n=2 Participants
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)
|
|---|---|
|
Progression-free Survival (PFS) at 1 Year
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsProportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Capecitabine 1000 mg/m²
n=2 Participants
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)
|
|---|---|
|
Progression-free Survival (PFS) at 2 Years
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearProportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Capecitabine 1000 mg/m²
n=2 Participants
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 Survival (OS) at 1 Year
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsProportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.
Outcome measures
| Measure |
Capecitabine 1000 mg/m²
n=2 Participants
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 Survival (OS) at 2 Years
|
0 percentage of participants
|
Adverse Events
Capecitabine 1000 mg/m²
Serious events: 1 serious events
Other events: 2 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Capecitabine 1000 mg/m²
n=2 participants at risk
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.
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive disease
|
50.0%
1/2 • Number of events 1 • 2 years
|
Other adverse events
| Measure |
Capecitabine 1000 mg/m²
n=2 participants at risk
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.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Hand Cramping
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Cardiac disorders
Heart Burn
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hypertension
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
General disorders
Fatigue
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Infections and infestations
Hand and Foot Syndrome
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
General disorders
Nausea
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
General disorders
Weight Loss
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
AST increase
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Renal and urinary disorders
Alk P'Tase increase
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dysguesia
|
50.0%
1/2 • Number of events 1 • 2 years
|
|
General disorders
Rash
|
50.0%
1/2 • Number of events 1 • 2 years
|
Additional Information
Alexander Dimitrios Colevas, MD
Stanford University Medical Center
Phone: 650-724-9707
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place