Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT02218164|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2014
Results First Posted : July 20, 2018
Last Update Posted : August 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Squamous Cell Carcinoma of Skin Carcinoma, Squamous Cell||Drug: Pegylated Interferon alpha-2b Drug: Capecitabine Drug: 5-FU||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma|
|Actual Study Start Date :||August 12, 2014|
|Actual Primary Completion Date :||July 19, 2017|
|Estimated Study Completion Date :||December 2020|
Experimental: Capecitabine or 5-FU with Pegylated Interferon alpha-2b
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 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.
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.
Other Name: 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.
Other Name: 5-fluorouracil
- Objective Response Rate (ORR) [ Time Frame: 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.
- Progression Free Survival (PFS) [ Time Frame: 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.
- Overall Survival (OS) [ Time Frame: 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.
- Occurence of Treatment Related Serious Adverse Events (SAEs) [ Time Frame: 1 year ]Number of participants with treatment emergent SAEs, overall and per Event Description.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02218164
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Christine Chung, M.D.||H. Lee Moffitt Cancer Center and Research Institute|