Recurrent Skin Cancer, Squamous Cell Carcinoma of the Skin
Conditions
Brief summary
Phase 2 evaluation of capecitabine in patients with advanced or recurrent squamous cell carcinoma of the skin.
Detailed 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.
Interventions
DRUGCapecitabine
Given orally
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Squamous cell carcinoma of the skin or unknown primary lesions at the time of diagnosis if metastatic disease present with a history of plausible primary skin site removed in the past. Example: squamous cell carcinoma in neck or parotid lymph nodes with no identifiable mucosal primary but with a history of the removal of one or more early stage squamous cell carcinomas of the skin in an anatomically relevant lymphatic drainage region would be eligible * Measurable disease, defined as at least 1 lesion that can be accurately measured in at least 1 dimension as ≥ 10 mm with computed tomography (CT) scan; magnetic resonance imaging (MRI); or calipers during clinical exam * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%) * Life expectancy greater than 3 months * Absolute neutrophil count ≥ 1,000/mcL * Platelets ≥ 100,000/mcL * Total bilirubin * Within normal institutional limits OR * ≤ 2 x upper limit of normal (ULN) if participant has Gilbert's syndrome (elevated unconjugated bilirubin from decreased UDP glucuronosyltransferase 1 family, polypeptide A1 \[UGT1A1\] activity) * Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) ≤ 2.5 x institutional ULN or up to 5 X ULN if known to be caused by liver metastases * Creatinine OR * \< 1.3 mg/dL OR * Creatinine clearance ≥ 30 mL/min/1.73 m2 for patients with creatinine levels above institutional normal (Note creatinine clearances between 30 and 49 mg/dL necessitate dose modification) * For participants with a history of coronary artery disease (CAD)/myocardial infarction (MI) or congestive heart failure (CHF), ejection fraction (EF) ≥ 50% by multi-gated acquisition (MUGA) or echocardiogram (exceptions by PI discretion)
Exclusion criteria
* Prior treatment with systemic capecitabine or prodrugs * Prior treatment with systemic fluorouracil (5-FU) or prodrugs (prior topical treatment with 5FU is permitted if recovered from any toxicities \> grade 1, and after at least 5 half-lives of the last systemically administered agent have passed) * Receiving any other investigational agents or anti-cancer treatments * Candidates for curative locoregional treatment (patients with recurrent locoregional disease following surgery and/ or radiation for which a resection is unacceptably morbid and unlikely to be curative are eligible) * History of allergic reactions attributed to compounds of similar chemical or biologic composition to capecitabine * Uncontrolled concurrent illness including, but not limited to: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Cardiac arrhythmia * Psychiatric illness/social situations that would limit compliance with study requirements * Pregnant * Lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | 9 weeks (3 cycles) | Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free Survival (PFS) at 1 Year | 1 year | Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates. |
| Progression-free Survival (PFS) at 2 Years | 2 years | Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates. |
| Overall Survival (OS) at 1 Year | 1 year | Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates. |
| Overall Survival (OS) at 2 Years | 2 years | Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 2 |
| Total | 2 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Capecitabine 1000 mg/m² |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 2 |
| other Total, other adverse events | 2 / 2 |
| serious Total, serious adverse events | 1 / 2 |
Outcome results
Primary
Objective Response Rate (ORR)
Response assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)
Time frame: 9 weeks (3 cycles)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine 1000 mg/m² | Objective Response Rate (ORR) | 0 percentage of participants |
Secondary
Overall Survival (OS) at 1 Year
Proportion of participants with overall survival (OS) at 1 year, as calculated based on Kaplan-Meier estimates.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine 1000 mg/m² | Overall Survival (OS) at 1 Year | 50 percentage of participants |
Secondary
Overall Survival (OS) at 2 Years
Proportion of participants with overall survival (OS) at 2 years, as calculated based on Kaplan-Meier estimates.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine 1000 mg/m² | Overall Survival (OS) at 2 Years | 0 percentage of participants |
Secondary
Progression-free Survival (PFS) at 1 Year
Proportion of participants with progression-free survival (PFS) at 1 year, as calculated based on Kaplan-Meier estimates.
Time frame: 1 year
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine 1000 mg/m² | Progression-free Survival (PFS) at 1 Year | 50 percentage of participants |
Secondary
Progression-free Survival (PFS) at 2 Years
Proportion of participants with progression-free survival (PFS) at 2 years, as calculated based on Kaplan-Meier estimates.
Time frame: 2 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Capecitabine 1000 mg/m² | Progression-free Survival (PFS) at 2 Years | 0 percentage of participants |