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Trial record 26 of 295 for:    IFNA2 AND PEG-interferon alfa-2b

Capecitabine or 5-FU With Pegylated Interferon Alpha-2b in Unresectable/Metastatic Cutaneous Squamous Cell Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02218164
Recruitment Status : Active, not recruiting
First Posted : August 15, 2014
Results First Posted : July 20, 2018
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Squamous Cell Carcinoma of Skin
Carcinoma, Squamous Cell
Interventions Drug: Pegylated Interferon alpha-2b
Drug: Capecitabine
Drug: 5-FU
Enrollment 8
Recruitment Details Participants were recruited at Moffitt Cancer Center from August 2014 through May 2017.
Pre-assignment Details  
Arm/Group Title Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Hide Arm/Group Description

Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.

After 3 cycles, new imaging studies will be performed to 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).

Period Title: Overall Study
Started 8
Completed 8
Not Completed 0
Arm/Group Title Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Hide Arm/Group Description

Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.

After 3 cycles, new imaging studies will be performed to 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).

Overall Number of Baseline Participants 8
Hide Baseline Analysis Population Description
All participants.
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 8 participants
72
(63 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
0
   0.0%
Male
8
 100.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
White Non-Hispanic
8
 100.0%
Black or African American
0
   0.0%
Asian
0
   0.0%
Hispanic or Latino
0
   0.0%
Other
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 8 participants
8
1.Primary Outcome
Title Objective Response Rate (ORR)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Hide Arm/Group Description:

Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.

After 3 cycles, new imaging studies will be performed to 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).

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
Stable Disease
4
  50.0%
Complete Response
1
  12.5%
Partial Response
1
  12.5%
2.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Hide Arm/Group Description:

Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.

After 3 cycles, new imaging studies will be performed to 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).

Overall Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: months
11.3 [1] 
(8.21 to NA)
[1]
Upper limit never crosses the 50% threshold on the Kaplan Meier curve.
3.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who received study treatment.
Arm/Group Title Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Hide Arm/Group Description:

Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.

After 3 cycles, new imaging studies will be performed to 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).

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
Expired in less than a year
4
  50.0%
Alive at the end of the year
2
  25.0%
Had not completed survival follow-up at closeout
2
  25.0%
4.Secondary Outcome
Title Occurence of Treatment Related Serious Adverse Events (SAEs)
Hide Description Number of participants with treatment emergent SAEs, overall and per Event Description.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Hide Arm/Group Description:

Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.

After 3 cycles, new imaging studies will be performed to 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).

Overall Number of Participants Analyzed 8
Measure Type: Count of Participants
Unit of Measure: Participants
Any Related SAE
1
  12.5%
Dehydration
1
  12.5%
INR Increased
1
  12.5%
Time Frame 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Hide Arm/Group Description

Capecitabine pills on day 1 thru day 14 and be off for 7 days (day 15-day 21). 5-FU days 1-4 of each 21 day cycle. Interferon alpha-2b injection weekly every week. 3 week period is referred to as one cycle.

After 3 cycles, new imaging studies will be performed to 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).

All-Cause Mortality
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Affected / at Risk (%)
Total   1/8 (12.50%)    
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Affected / at Risk (%) # Events
Total   5/8 (62.50%)    
Gastrointestinal disorders   
Dysphagia * 1  1/8 (12.50%)  1
General disorders   
General disorders and administration site conditions - Other, Medication error * 1  1/8 (12.50%)  1
Injury, poisoning and procedural complications   
Fall * 1  1/8 (12.50%)  1
Investigations   
INR increased * 1  1/8 (12.50%)  1
Metabolism and nutrition disorders   
Dehydration * 1  2/8 (25.00%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms - Other, Death due to disease progression * 1  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Aspiration * 1  2/8 (25.00%)  2
Vascular disorders   
Thromboembolic event * 1  1/8 (12.50%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Capecitabine or 5-FU With Pegylated Interferon Alpha-2b
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Anemia * 1  2/8 (25.00%)  2
Cardiac disorders   
Cardiac disorders - Other, Atrial fibrillation with rapid ventricular response * 1  1/8 (12.50%)  1
Ear and labyrinth disorders   
Ear pain * 1  1/8 (12.50%)  1
Eye disorders   
Eye disorders - Other, Right eye edema * 1  1/8 (12.50%)  1
Gastrointestinal disorders   
Diarrhea * 1  2/8 (25.00%)  2
Dysphagia * 1  1/8 (12.50%)  1
Constipation * 1  1/8 (12.50%)  1
Gastrointestinal disorders - Other, Stomatitis * 1  1/8 (12.50%)  1
Nausea * 1  1/8 (12.50%)  1
Stomach pain * 1  1/8 (12.50%)  1
Vomiting * 1  1/8 (12.50%)  1
General disorders   
General disorders and administration site conditions - Other, Failure to thrive * 1  2/8 (25.00%)  3
Injection site reaction * 1  3/8 (37.50%)  4
Chills * 1  2/8 (25.00%)  2
Fatigue * 1  2/8 (25.00%)  4
Fever * 1  2/8 (25.00%)  2
Edema face * 1  1/8 (12.50%)  1
Pain * 1  1/8 (12.50%)  1
Infections and infestations   
Infections and infestations - Other, Staph * 1  2/8 (25.00%)  2
Skin infection * 1  1/8 (12.50%)  1
Urinary tract infection * 1  1/8 (12.50%)  1
Injury, poisoning and procedural complications   
Fall * 1  2/8 (25.00%)  2
Dermatitis radiation * 1  1/8 (12.50%)  2
Radiation recall reaction (dermatologic) * 1  1/8 (12.50%)  1
Investigations   
White blood cell decreased * 1  4/8 (50.00%)  6
Weight loss * 1  3/8 (37.50%)  6
INR increased * 1  1/8 (12.50%)  1
Neutrophil count decreased * 1  1/8 (12.50%)  1
Platelet count decreased * 1  1/8 (12.50%)  1
Metabolism and nutrition disorders   
Anorexia * 1  5/8 (62.50%)  5
Dehydration * 1  2/8 (25.00%)  3
Hypokalemia * 1  1/8 (12.50%)  1
Hyponatremia * 1  1/8 (12.50%)  1
Hypophosphatemia * 1  1/8 (12.50%)  1
Musculoskeletal and connective tissue disorders   
Myalgia * 1  2/8 (25.00%)  3
Back pain * 1  1/8 (12.50%)  1
Bone pain * 1  1/8 (12.50%)  1
Joint range of motion decreased * 1  1/8 (12.50%)  1
Trismus * 1  1/8 (12.50%)  1
Nervous system disorders   
Peripheral sensory neuropathy * 1  2/8 (25.00%)  2
Dysgeusia * 1  1/8 (12.50%)  1
Headache * 1  1/8 (12.50%)  1
Seizure * 1  1/8 (12.50%)  1
Tremor * 1  1/8 (12.50%)  1
Psychiatric disorders   
Confusion * 1  1/8 (12.50%)  1
Depression * 1  1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea * 1  3/8 (37.50%)  3
Hoarseness * 1  1/8 (12.50%)  1
Nasal congestion * 1  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Pruritus * 1  3/8 (37.50%)  4
Palmar-plantar erythrodysesthesia syndrome * 1  2/8 (25.00%)  2
Skin and subcutaneous tissue disorders - Other, Arm wound (non-lesion) * 1  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders - Other, New Skin cancer - different histology * 1  1/8 (12.50%)  1
Skin and subcutaneous tissue disorders - Other, Finger cracking * 1  1/8 (12.50%)  1
Dry skin * 1  1/8 (12.50%)  1
Nail ridging * 1  1/8 (12.50%)  1
Vascular disorders   
Hypotension * 1  3/8 (37.50%)  4
Hematoma * 1  1/8 (12.50%)  1
1
Term from vocabulary, CTCAE (4.0)
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Christine Chung
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-5061
EMail: christine.chung@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT02218164     History of Changes
Other Study ID Numbers: MCC-17759
First Submitted: August 14, 2014
First Posted: August 15, 2014
Results First Submitted: June 21, 2018
Results First Posted: July 20, 2018
Last Update Posted: September 9, 2019