Trial · NCT02218164
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma
NCT02218164, Phase 2, Completed, H. Lee Moffitt Cancer Center and Research Institute; results first posted 2018-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma. Trials, record NCT02218164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02218164
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma
- NCT number
- NCT02218164
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Conditions
- Squamous Cell Carcinoma of Skin, Carcinoma, Squamous Cell
- Interventions
- Pegylated Interferon alpha-2b, Capecitabine, 5-FU
- First posted
- 2014-08-15
- Last updated
- 2022-10-07
- Results first posted
- 2018-07-20
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Objective Response Rate (ORR) | 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 sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started. |
| Secondary | Progression Free Survival (PFS) | 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. |
| Secondary | Overall Survival (OS) | 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. |
| Secondary | Occurence of Treatment Related Serious Adverse Events (SAEs) | 1 year | Number of participants with treatment emergent SAEs, overall and per Event Description. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Objective Response Rate (ORR) | 9 weeks per participant | All participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Progression Free Survival (PFS) | 1 year | All participants | months | MEDIAN |
| SECONDARY | Overall Survival (OS) | 1 year | All participants who received study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Occurence of Treatment Related Serious Adverse Events (SAEs) | 1 year | All participants | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Objective Response Rate (ORR) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | Stable Disease | 4 | Participants | |
| Objective Response Rate (ORR) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | Complete Response | 1 | Participants | |
| Objective Response Rate (ORR) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | Partial Response | 1 | Participants | |
| Progression Free Survival (PFS) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 11.3 | 95% Confidence Interval 8.21 to NA | months | |
| Overall Survival (OS) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | Expired in less than a year | 4 | Participants | |
| Overall Survival (OS) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | Alive at the end of the year | 2 | Participants | |
| Overall Survival (OS) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | Had not completed survival follow-up at closeout | 2 | Participants | |
| Occurence of Treatment Related Serious Adverse Events (SAEs) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | Any Related SAE | 1 | Participants | |
| Occurence of Treatment Related Serious Adverse Events (SAEs) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | Dehydration | 1 | Participants | |
| Occurence of Treatment Related Serious Adverse Events (SAEs) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | INR Increased | 1 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 8 | |
| Overall Study | COMPLETED | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 8 | |
| Overall Study | NOT COMPLETED | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 0 |
Source ClinicalTrials.gov
Adverse events66
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Pruritus | Skin and subcutaneous tissue disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 3 | 8 | 4 |
| other | Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 2 | 8 | 2 |
| other | Skin and subcutaneous tissue disorders - Other, Arm wound (non-lesion) | Skin and subcutaneous tissue disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 1 | 8 | 1 |
| other | Skin and subcutaneous tissue disorders - Other, New Skin cancer - different histology | Skin and subcutaneous tissue disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 1 | 8 | 1 |
| other | Skin and subcutaneous tissue disorders - Other, Finger cracking | Skin and subcutaneous tissue disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 1 | 8 | 1 |
| other | Dry skin | Skin and subcutaneous tissue disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 1 | 8 | 1 |
| other | Nail ridging | Skin and subcutaneous tissue disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 1 | 8 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 2 | 8 | 2 |
| other | Dysphagia | Gastrointestinal disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 1 | 8 | 1 |
| other | Constipation | Gastrointestinal disorders | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 1 | 8 | 1 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 1 | 8 |
| Total, other adverse events | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 8 | 8 |
| Total, serious adverse events | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 5 | 8 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02218164
GET https://conductscience.org/api/trials/v1/NCT02218164/events?page=2