Trial Outcomes & Findings for 5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer (NCT NCT01658813)
NCT ID: NCT01658813
Last Updated: 2018-03-21
Results Overview
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.
COMPLETED
PHASE2
18 participants
Assessed up to 2 years
2018-03-21
Participant Flow
Participant milestones
| Measure |
5-FU and Interferon-alfa-2b
All patients received 5-Fluorouracil and Interferon-alfa-2b
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
Eligible
|
18
|
|
Overall Study
Treated
|
18
|
|
Overall Study
COMPLETED
|
15
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
5-FU and Interferon-alfa-2b
All patients received 5-Fluorouracil and Interferon-alfa-2b
|
|---|---|
|
Overall Study
Disease progression
|
3
|
Baseline Characteristics
5-Fluorouracil Followed by Interferon-alfa-2b in Previously-treated Metastatic Gastrointestinal, Kidney, or Lung Cancer
Baseline characteristics by cohort
| Measure |
Number of Participants
n=18 Participants
5-Fluorouracil and Interferon-alfa-2b
|
|---|---|
|
Age, Continuous
|
57 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed up to 2 yearsPopulation: Data was not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 years.Population: Data was not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Data was not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up tp 2 yearsPopulation: Data was not collected
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: up to 2 yearsPopulation: Data was not collected
Median survival was measured from date of entry on study until date of death
Outcome measures
Outcome data not reported
Adverse Events
Number of Participants
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Number of Participants
n=18 participants at risk
5-Fluorouracil and Interferon-alfa-2b
|
|---|---|
|
General disorders
Rigors
|
66.7%
12/18
|
|
Gastrointestinal disorders
Nausea/emesis
|
55.6%
10/18
|
|
General disorders
Fever
|
38.9%
7/18
|
|
General disorders
Fatigue
|
33.3%
6/18
|
|
General disorders
Headache
|
22.2%
4/18
|
|
General disorders
arthralgia/myalgia
|
16.7%
3/18
|
|
General disorders
Catarrhal symptoms
|
16.7%
3/18
|
|
Gastrointestinal disorders
Constipation
|
16.7%
3/18
|
|
Investigations
Aspartate aminotransferase elevation
|
16.7%
3/18
|
|
Investigations
thrombocytopenia
|
16.7%
3/18
|
|
Investigations
Leukopenia
|
11.1%
2/18
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.1%
2/18
|
|
Metabolism and nutrition disorders
anorexia
|
11.1%
2/18
|
|
General disorders
flu-like symptoms
|
22.2%
4/18
|
|
Blood and lymphatic system disorders
Anemia
|
5.6%
1/18
|
|
Gastrointestinal disorders
Diarrhea
|
5.6%
1/18
|
|
Gastrointestinal disorders
Gastroesophageal reflux
|
5.6%
1/18
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
5.6%
1/18
|
|
Psychiatric disorders
insomnia
|
5.6%
1/18
|
|
Investigations
Alanine aminotransferase elevation
|
5.6%
1/18
|
|
Investigations
Alkaline phosphatase elevation
|
5.6%
1/18
|
|
General disorders
malaise
|
5.6%
1/18
|
|
General disorders
localized edema
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
pruritus
|
5.6%
1/18
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.6%
1/18
|
|
Cardiac disorders
sinus tachycardia
|
5.6%
1/18
|
|
Metabolism and nutrition disorders
Dehydration
|
5.6%
1/18
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place