- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02218164
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma
A Phase 2 Study of Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Florida
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Tampa, Florida, United States, 33612
- H. Lee Moffitt Cancer Center and Research Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Must have histologically or cytologically confirmed squamous cell carcinoma of the skin. Potential participants who present with "squamous cell carcinoma of unknown primary lesions" at the time of diagnosis will be eligible if patients have a plausible primary skin site removed in the past. Similarly, potential participants with neck, parotid, or facial lymph nodes positive for squamous cell carcinoma with no identifiable mucosal primary would also be eligible.
- Must have measurable disease, defined by Response according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as at least one lesion that can be accurately measured in at least one dimension of >10 mm by CT, MRI, or calipers
- There is no limitation to prior treatments with local, regional, topical or systemic agents, except for prior systemic treatment with 5-fluorouracil or prodrugs thereof. Prior topical treatment with 5-fluorouracil is permitted. Patients who are on chronic daily doses of prednisone of greater than 10 mg are excluded. There is no restriction on timing of last treatments as long as patients have recovered from all expected toxicities and at least 21 days have passed since last administration.
- Life expectancy of greater than 3 months
- Eastern Cooperative Oncology Group (ECOG) performance status <=2 (Karnofsky >=60%
- Must have normal organ and marrow function
- Must not be candidates for curative locoregional treatments. Patients with recurrent locoregional disease following surgery and/or radiation for who a resection is unacceptably morbid and unlikely to be curative are eligible.
- Women of child-bearing potential and men must agree to use adequate contraception (barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability to understand and the willingness to sign a written informed consent document
Exclusion Criteria:
- Have had chemotherapy or radiotherapy within 21 days (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 3 weeks earlier
- May not be receiving any other investigational agents
- Known brain metastases
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to either 5-FU/Capecitabine or Interferon
- Uncontrolled, ongoing illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, psychiatric illness/social situations that would limit compliance with study requirements
- Women who are pregnant or breastfeeding
- Any heart or lung transplant patient on immunosuppressive agents. Renal transplant patients are allowed if patient is willing to reduce immunosuppressive agents and understand risk of rejection and possible need to return to dialysis. Patients with Chronic Lymphocytic Leukemia (CLL) or other hematologic malignancies are allowed as long as they meet other criteria listed above.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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 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.
Other Names:
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 Names:
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 Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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9 weeks per participant
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival (PFS)
Time Frame: 1 year
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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.
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1 year
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Overall Survival (OS)
Time Frame: 1 year
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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.
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1 year
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Occurence of Treatment Related Serious Adverse Events (SAEs)
Time Frame: 1 year
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Number of participants with treatment emergent SAEs, overall and per Event Description.
|
1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Christine Chung, M.D., H. Lee Moffitt Cancer Center and Research Institute
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms, Glandular and Epithelial
- Neoplasms, Squamous Cell
- Carcinoma
- Carcinoma, Squamous Cell
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Interferons
- Interferon-alpha
- Fluorouracil
- Capecitabine
- Interferon alpha-2
- Peginterferon alfa-2b
Other Study ID Numbers
- MCC-17759
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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