Trial Outcomes & Findings for Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma (NCT NCT02218164)
NCT ID: NCT02218164
Last Updated: 2022-10-07
Results Overview
ORR: Stable Disease (SD); Partial Response (PR); Complete Response (CR). Response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
8 participants
Primary outcome timeframe
9 weeks per participant
Results posted on
2022-10-07
Participant Flow
Participants were recruited at Moffitt Cancer Center from August 2014 through May 2017.
Participant milestones
| Measure |
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.
After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
n=8 Participants
Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.
After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).
|
|---|---|
|
Age, Continuous
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White Non-Hispanic
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
8 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 9 weeks per participantPopulation: All participants
ORR: Stable Disease (SD); Partial Response (PR); Complete Response (CR). Response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR: disappearance of all target lesions; PR: At least a 30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
n=8 Participants
Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.
After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).
|
|---|---|
|
Objective Response Rate (ORR)
Stable Disease
|
4 Participants
|
|
Objective Response Rate (ORR)
Complete Response
|
1 Participants
|
|
Objective Response Rate (ORR)
Partial Response
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All participants
PFS: Alive without RECIST progression. Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
Outcome measures
| Measure |
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
n=8 Participants
Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.
After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).
|
|---|---|
|
Progression Free Survival (PFS)
|
11.3 months
Interval 8.21 to
Upper limit never crosses the 50% threshold on the Kaplan Meier curve.
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All participants who received study treatment.
OS: The time from registration to death or date of last contact. Participants with overall survival at 1 year. Kaplan-Meier estimator will be utilized.
Outcome measures
| Measure |
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
n=8 Participants
Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.
After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).
|
|---|---|
|
Overall Survival (OS)
Expired in less than a year
|
4 Participants
|
|
Overall Survival (OS)
Alive at the end of the year
|
2 Participants
|
|
Overall Survival (OS)
Had not completed survival follow-up at closeout
|
2 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All participants
Number of participants with treatment emergent SAEs, overall and per Event Description.
Outcome measures
| Measure |
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
n=8 Participants
Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.
After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).
|
|---|---|
|
Occurence of Treatment Related Serious Adverse Events (SAEs)
Any Related SAE
|
1 Participants
|
|
Occurence of Treatment Related Serious Adverse Events (SAEs)
Dehydration
|
1 Participants
|
|
Occurence of Treatment Related Serious Adverse Events (SAEs)
INR Increased
|
1 Participants
|
Adverse Events
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Serious events: 5 serious events
Other events: 8 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
n=8 participants at risk
Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.
After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).
|
|---|---|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
General disorders
General disorders and administration site conditions - Other, Medication error
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Investigations
INR increased
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms - Other, Death due to disease progression
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Vascular disorders
Thromboembolic event
|
12.5%
1/8 • Number of events 1 • 3 years
|
Other adverse events
| Measure |
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
n=8 participants at risk
Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.
After 3 cycles, new imaging studies will be performed to measure how the disease is responding to treatment. Participants whose disease is stable or improved will undergo an additional 3 cycles of therapy and the imaging studies will be repeated. Again, participants whose disease is stable or improved will undergo a final 3 cycles of treatment (a total 27 weeks of treatment).
|
|---|---|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
3/8 • Number of events 4 • 3 years
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Arm wound (non-lesion)
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, New Skin cancer - different histology
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, Finger cracking
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Skin and subcutaneous tissue disorders
Nail ridging
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, Stomatitis
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Stomach pain
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
General disorders
General disorders and administration site conditions - Other, Failure to thrive
|
25.0%
2/8 • Number of events 3 • 3 years
|
|
General disorders
Injection site reaction
|
37.5%
3/8 • Number of events 4 • 3 years
|
|
General disorders
Chills
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
General disorders
Fatigue
|
25.0%
2/8 • Number of events 4 • 3 years
|
|
General disorders
Fever
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
General disorders
Edema face
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Investigations
White blood cell decreased
|
50.0%
4/8 • Number of events 6 • 3 years
|
|
Investigations
Weight loss
|
37.5%
3/8 • Number of events 6 • 3 years
|
|
Investigations
INR increased
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Investigations
Neutrophil count decreased
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Investigations
Platelet count decreased
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Anorexia
|
62.5%
5/8 • Number of events 5 • 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
25.0%
2/8 • Number of events 3 • 3 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • Number of events 3 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Nervous system disorders
Seizure
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Injury, poisoning and procedural complications
Fall
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
12.5%
1/8 • Number of events 2 • 3 years
|
|
Injury, poisoning and procedural complications
Radiation recall reaction (dermatologic)
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Infections and infestations
Infections and infestations - Other, Staph
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Infections and infestations
Skin infection
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
37.5%
3/8 • Number of events 3 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Vascular disorders
Hypotension
|
37.5%
3/8 • Number of events 4 • 3 years
|
|
Vascular disorders
Hematoma
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
2/8 • Number of events 2 • 3 years
|
|
Psychiatric disorders
Confusion
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Psychiatric disorders
Depression
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Cardiac disorders
Cardiac disorders - Other, Atrial fibrillation with rapid ventricular response
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Ear and labyrinth disorders
Ear pain
|
12.5%
1/8 • Number of events 1 • 3 years
|
|
Eye disorders
Eye disorders - Other, Right eye edema
|
12.5%
1/8 • Number of events 1 • 3 years
|
Additional Information
Dr. Christine Chung
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-5061
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place