H. Lee Moffitt Cancer Center and Research Institute
Who can join
18 and older, any sex, with Squamous Cell Carcinoma of Skin or Carcinoma, Squamous Cell. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR)Primary· 9 weeks per participant
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 sufficie
Stable Disease
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
4
Complete Response
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
1
Partial Response
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
1
Progression Free Survival (PFS)Secondary· 1 year
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.
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
11.3
8.21 – NA
Overall Survival (OS)Secondary· 1 year
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.
Expired in less than a year
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
4
Alive at the end of the year
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
2
Had not completed survival follow-up at closeout
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
2
Occurence of Treatment Related Serious Adverse Events (SAEs)Secondary· 1 year
Number of participants with treatment emergent SAEs, overall and per Event Description.
Any Related SAE
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
1
Dehydration
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
1
INR Increased
Group
Value
95% CI
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
1
Adverse events — posted to ClinicalTrials.gov
Time frame: 3 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Serious: 5/8 (63%)
Deaths: 1/8
Serious adverse events (8 terms)
Reaction
System
Capecitabine or 5-FU With …
Dehydration
Metabolism and nutrition disorders
—
Aspiration
Respiratory, thoracic and mediastinal disorders
—
Dysphagia
Gastrointestinal disorders
—
General disorders and administration site conditions - Other, Medication error
General disorders
—
Fall
Injury, poisoning and procedural complications
—
INR increased
Investigations
—
Neoplasms - Other, Death due to disease progression
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
Thromboembolic event
Vascular disorders
—
Other adverse events (58 terms — click to expand)
Reaction
System
Capecitabine or 5-FU With …
Anorexia
Metabolism and nutrition disorders
—
White blood cell decreased
Investigations
—
Pruritus
Skin and subcutaneous tissue disorders
—
Injection site reaction
General disorders
—
Weight loss
Investigations
—
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
Hypotension
Vascular disorders
—
Palmar-plantar erythrodysesthesia syndrome
Skin and subcutaneous tissue disorders
—
Diarrhea
Gastrointestinal disorders
—
General disorders and administration site conditions - Other, Failure to thrive
General disorders
—
Chills
General disorders
—
Fatigue
General disorders
—
Fever
General disorders
—
Dehydration
Metabolism and nutrition disorders
—
Myalgia
Musculoskeletal and connective tissue disorders
—
Peripheral sensory neuropathy
Nervous system disorders
—
Fall
Injury, poisoning and procedural complications
—
Infections and infestations - Other, Staph
Infections and infestations
—
Anemia
Blood and lymphatic system disorders
—
Skin and subcutaneous tissue disorders - Other, Arm wound (non-lesion)
Skin and subcutaneous tissue disorders
—
Skin and subcutaneous tissue disorders - Other, New Skin cancer - different histology
Skin and subcutaneous tissue disorders
—
Skin and subcutaneous tissue disorders - Other, Finger cracking
The purpose of this study is to find out if the combination of two established anti-cancer therapies are beneficial in patients with squamous cell carcinoma of the skin. Specifically, investigators want to determine if the combination of 5-FU/Capecitabine (oral pills) and Interferon alpha-2b (injection) can help people with advanced cases of squamous cell carcinoma of the skin. For participants that are not approved for oral capecitabine, treating physicians will use continuous infusion 5-FU. Both 5-FU/Capecitabine and Interferon alpha-2b have been used separately to treat squamous cell carcinoma of the skin and are FDA approved in other cancer types.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by H. Lee Moffitt Cancer Center and Research Institute
Last refreshed: 7 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02218164.