A Phase 2 interventional study of Pegylated Interferon alpha-2b and Capecitabine in Squamous Cell Carcinoma of Skin and Carcinoma, Squamous Cell, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-07.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Phase 2, Interventional, and Treatment
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.
1,779 studies on the registry are indexed under Carcinoma, Squamous Cell; 409 are open to participants now.
This study's enrollment of 8 is below the median of 45 across 1,417 interventional studies indexed under Carcinoma, Squamous Cell.
Browse Carcinoma, Squamous Cell studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 539 studies on the registry; 74 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
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Exclusion Criteria:
Participants will start the Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). Participants will receive 5-FU days 1-4 of each 21 day cycle. Participants will receive the Interferon alpha-2b injection weekly every week. The three week period is referred to as one cycle. After three cycles, new imaging studies will be performed that will 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).
Drug: Pegylated Interferon alpha-2b · Drug: Capecitabine · Drug: 5-FU
Drug administration will occur on an outpatient basis at the infusion center at Moffitt Cancer Center. Dose will be weight-based. Starting treatment doses of 3 mcg/kg will be given subcutaneously (SC) injection in the thigh, abdominal wall, or upper arm every week for a total of 27 weeks as tolerated.
Also known as: PEG Interferon Alpha-2b, PEG-INTRON, PEGASYS
Drug administration will be on an outpatient basis. Capecitabine will be administered at an initial dose of 800 mg/m\^2 by mouth twice daily on days 1-14 of a 21 day cycle with days 15-21 off. This cycle will be repeated every 21 days during the study for a maximum of 9 cycles as tolerated. Administration via feeding tube in patients unable to swallow is permitted.
Also known as: Xeloda
If participants are not able to acquire oral capecitabine, then treating physicians will start participants on infusional 5-FU which can be delivered via standard of care. Participants will need to have a port placed for continuous infusion treatments. 5-FU pumps will be activated in the infusion center at Moffitt Cancer Center with a starting dose of 800 mg/m\^2 days 1-4, with pump removal on day 5 at the infusion center. 5-FU pumps will be attached every 21 days (1 cycle) for a maximum of 9 cycles.
Also known as: 5-fluorouracil
Objective Response Rate (ORR)
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.
Time frame: 9 weeks per participant
Progression Free Survival (PFS)
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.
Time frame: 1 year
Overall Survival (OS)
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.
Time frame: 1 year
Occurence of Treatment Related Serious Adverse Events (SAEs)
Number of participants with treatment emergent SAEs, overall and per Event Description.
Time frame: 1 year
Participants were recruited at Moffitt Cancer Center from August 2014 through May 2017.
| Milestone | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| Started | 8 |
| Completed | 8 |
| Not completed | 0 |
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.
| Participants | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| Stable Disease | 4 |
| Complete Response | 1 |
| Partial Response | 1 |
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.
| months | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| Progression Free Survival (PFS) | 11.3 (8.21 to NA) |
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.
| Participants | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| Expired in less than a year | 4 |
| Alive at the end of the year | 2 |
| Had not completed survival follow-up at closeout | 2 |
Number of participants with treatment emergent SAEs, overall and per Event Description.
| Participants | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| Any Related SAE | 1 |
| Dehydration | 1 |
| INR Increased | 1 |
Collected over 3 years. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Capecitabine or 5-FU With Pegylated Interferon Alpha-2b | 1/8 (12.5%) | 5/8 (62.5%) | 8/8 (100%) |
| Event | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| DehydrationMetabolism and nutrition disorders | 2/8 |
| AspirationRespiratory, thoracic and mediastinal disorders | 2/8 |
| DysphagiaGastrointestinal disorders | 1/8 |
| General disorders and administration site conditions - Other, Medication errorGeneral disorders | 1/8 |
| FallInjury, poisoning and procedural complications | 1/8 |
| INR increasedInvestigations | 1/8 |
| Neoplasms - Other, Death due to disease progressionNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/8 |
| Thromboembolic eventVascular disorders | 1/8 |
| Event | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| AnorexiaMetabolism and nutrition disorders | 5/8 |
| White blood cell decreasedInvestigations | 4/8 |
| PruritusSkin and subcutaneous tissue disorders | 3/8 |
| Injection site reactionGeneral disorders | 3/8 |
| Weight lossInvestigations | 3/8 |
| DyspneaRespiratory, thoracic and mediastinal disorders | 3/8 |
| HypotensionVascular disorders | 3/8 |
| Palmar-plantar erythrodysesthesia syndromeSkin and subcutaneous tissue disorders | 2/8 |
| DiarrheaGastrointestinal disorders | 2/8 |
| General disorders and administration site conditions - Other, Failure to thriveGeneral disorders | 2/8 |
All participants.
| Age, Continuous(years) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| Mean | 72 (63 to 80) |
| Sex: Female, Male(Participants) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| Female | 0 |
| Male | 8 |
| Race/Ethnicity, Customized(Participants) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| White Non-Hispanic | 8 |
| Black or African American | 0 |
| Asian | 0 |
| Hispanic or Latino | 0 |
| Other | 0 |
| Region of Enrollment(participants) | Capecitabine or 5-FU With Pegylated Interferon Alpha-2b |
|---|---|
| United States | 8 |
Documents are hosted by the registry — open the source record to download them.
Ran from Aug 2014 to primary completion in Jul 2017, 35 months.
Results were first posted in Jul 2018, 1 year after primary completion.
Of 305 non-industry phase 2 interventional studies under Carcinoma, Squamous Cell, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 79. This study's 35 months is below that.
Counting every sponsor, half of 350 studies reached it within 49 months; a quarter within 33 and three quarters within 76.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Peginterferon alfa-2b · Capecitabine · Fluorouracil
H. Lee Moffitt Cancer Center and Research Institute →