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5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer

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ClinicalTrials.gov Identifier: NCT01658813
Recruitment Status : Completed
First Posted : August 7, 2012
Results First Posted : July 25, 2016
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Western Regional Medical Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Gastrointestinal Cancer Metastatic
Renal Cell Cancer Metastatic
Non Small Cell Lung Cancer Metastatic
Intervention Drug: 5-Fluorouracil and Interferon
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 5-FU and Interferon-alfa-2b
Hide Arm/Group Description All patients received 5-Fluorouracil and Interferon-alfa-2b
Period Title: Overall Study
Started 18
Eligible 18
Treated 18
Completed 15
Not Completed 3
Reason Not Completed
Disease progression             3
Arm/Group Title Number of Participants
Hide Arm/Group Description 5-Fluorouracil and Interferon-alfa-2b
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
57
(35 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
6
  33.3%
Male
12
  66.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Progression Free Survival
Hide Description Progression Free Survival (PFS) was calculated as the time (months) from date of the start of treatment to the date of first observed disease progression (per standard Response Evaluation Criteria In Solid Tumors [RECIST] or date of death from any cause, whichever came first, assessed up to 2 years. The actual date of tumor assessments was used for this calculation. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of one or more new lesions.
Time Frame Assessed up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title Progression Free Survival
Hide Arm/Group Description:
5-Fluorouracil and Interferon-alfa-2b
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Responses
Hide Description Radiographic studies to evaluate for response were done at 8 weeks (after 1 cycle). Standard RECIST response criteria were utilized. Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT scan: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame up to 2 years.
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title Number of Responders
Hide Arm/Group Description:
the number of patients responding
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title Response Rate
Hide Arm/Group Description:
percentage of patients responding
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Median Duration of Response
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by radiographic imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Up tp 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title Median Duration of Response
Hide Arm/Group Description:
The median duration of response was determined.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Median Survival
Hide Description Median survival was measured from date of entry on study until date of death
Time Frame up to 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
Data was not collected
Arm/Group Title Median Survival
Hide Arm/Group Description:
The median survival of patients treated on study was determined.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Number of Participants
Hide Arm/Group Description 5-Fluorouracil and Interferon-alfa-2b
All-Cause Mortality
Number of Participants
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Number of Participants
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Number of Participants
Affected / at Risk (%)
Total   18/18 (100.00%) 
Blood and lymphatic system disorders   
Anemia   1/18 (5.56%) 
Cardiac disorders   
sinus tachycardia *  1/18 (5.56%) 
Gastrointestinal disorders   
Nausea/emesis   10/18 (55.56%) 
Constipation   3/18 (16.67%) 
Diarrhea   1/18 (5.56%) 
Gastroesophageal reflux *  1/18 (5.56%) 
General disorders   
Rigors   12/18 (66.67%) 
Fever   7/18 (38.89%) 
Fatigue   6/18 (33.33%) 
Headache *  4/18 (22.22%) 
arthralgia/myalgia   3/18 (16.67%) 
Catarrhal symptoms   3/18 (16.67%) 
flu-like symptoms   4/18 (22.22%) 
malaise *  1/18 (5.56%) 
localized edema *  1/18 (5.56%) 
Investigations   
Aspartate aminotransferase elevation   3/18 (16.67%) 
thrombocytopenia   3/18 (16.67%) 
Leukopenia   2/18 (11.11%) 
Alanine aminotransferase elevation   1/18 (5.56%) 
Alkaline phosphatase elevation   1/18 (5.56%) 
Metabolism and nutrition disorders   
anorexia   2/18 (11.11%) 
Dehydration *  1/18 (5.56%) 
Psychiatric disorders   
insomnia *  1/18 (5.56%) 
Respiratory, thoracic and mediastinal disorders   
Cough   2/18 (11.11%) 
allergic rhinitis   1/18 (5.56%) 
Skin and subcutaneous tissue disorders   
pruritus   1/18 (5.56%) 
Rash   1/18 (5.56%) 
Indicates events were collected by systematic assessment
*
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
Name/Title: Jessica L. Coats
Organization: Western Regional Medical Center
Phone: 623-207-3899
Responsible Party: Western Regional Medical Center
ClinicalTrials.gov Identifier: NCT01658813     History of Changes
Other Study ID Numbers: 12-09
First Submitted: August 2, 2012
First Posted: August 7, 2012
Results First Submitted: December 29, 2015
Results First Posted: July 25, 2016
Last Update Posted: March 21, 2018