Trial Outcomes & Findings for Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery (NCT NCT01158534)
NCT ID: NCT01158534
Last Updated: 2012-08-07
Results Overview
The best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
17 participants
Primary outcome timeframe
at week 4 of cycle 2 and every other cycle thereafter
Results posted on
2012-08-07
Participant Flow
Patients accrued from medical clinic from June 2006 through July 2009
Participant milestones
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
STARTED
|
17
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Death
|
1
|
|
Overall Study
Other
|
1
|
Baseline Characteristics
Celecoxib and Recombinant Interferon Alfa-2b in Metastatic Kidney Cancer Who Have Undergone Surgery
Baseline characteristics by cohort
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
n=17 Participants
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age Continuous
|
62.9 years
STANDARD_DEVIATION 9.6 • n=93 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
17 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: at week 4 of cycle 2 and every other cycle thereafterThe best overall response is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The patient's best response assignment will depend on the achievement of both measurement and confirmation criteria. Objective response will be assessed by RECIST criteria.
Outcome measures
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
n=17 Participants
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Objective Response Rate Assessed by RECIST Criteria.
Complete Response
|
0 participants
|
|
Objective Response Rate Assessed by RECIST Criteria.
Partial Response
|
3 participants
|
|
Objective Response Rate Assessed by RECIST Criteria.
Stable Disease
|
5 participants
|
|
Objective Response Rate Assessed by RECIST Criteria.
No Response
|
9 participants
|
SECONDARY outcome
Timeframe: deathOverall survival measured in months and summarized using the Kaplan-Meier method.
Outcome measures
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
n=17 Participants
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Overall Survival
|
14.4 months
Interval 8.8 to 16.5
|
SECONDARY outcome
Timeframe: end of studyPopulation: Patients who achieved at least a partial response
The duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started, including baseline). The duration of overall CR is measured from the time measurement criteria are first met for CR until the first date that recurrent disease is objectively documented.
Outcome measures
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
n=3 Participants
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Duration of Response
|
8.7 months
Interval 3.7 to 14.7
|
SECONDARY outcome
Timeframe: to progressionProgression-free survival measured in months and summarized using the Kaplan-Meier method. Time to objective progression will be measured from the start of treatment until the criteria for progression are met, taking as reference the smallest measurements recorded since the treatment started, including baseline.
Outcome measures
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
n=17 Participants
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Progression-free Survival
|
5.6 months
Interval 3.0 to 12.9
|
SECONDARY outcome
Timeframe: at two months from start of treatmentPopulation: Patients that received treatment
To evaluate the effect of celecoxib and interferon alpha therapy on cellular immune parameters. Absolute change following two cycles of therapy.
Outcome measures
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
n=17 Participants
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Patients With Statistically Significant Change in Cellular Immune Parameters From Baseline to 2 Months
|
0 participants
|
Adverse Events
Celecoxib and Recombinant Interferon Alpha-2b
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
n=17 participants at risk
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Nervous system disorders
Seizures
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Cardiac disorders
Thrombosis/embolism
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
Other adverse events
| Measure |
Celecoxib and Recombinant Interferon Alpha-2b
n=17 participants at risk
Patients receive oral celecoxib twice daily and recombinant interferon alpha-2b subcutaneously, once daily, 5 times a week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Investigations
Alkaline Phosphatase
|
17.6%
3/17 • From time patients went on study to off study, a period of 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Metabolism and nutrition disorders
Anorexia
|
52.9%
9/17 • From time patients went on study to off study, a period of 4 years
|
|
Gastrointestinal disorders
Constipation
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
General disorders
Constitutional Symptoms-other
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Renal and urinary disorders
Creatinine
|
11.8%
2/17 • From time patients went on study to off study, a period of 4 years
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin-other
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
41.2%
7/17 • From time patients went on study to off study, a period of 4 years
|
|
Nervous system disorders
Dizziness/lightheadedness
|
23.5%
4/17 • From time patients went on study to off study, a period of 4 years
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
17.6%
3/17 • From time patients went on study to off study, a period of 4 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
11.8%
2/17 • From time patients went on study to off study, a period of 4 years
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
General disorders
Fatigue
|
82.4%
14/17 • From time patients went on study to off study, a period of 4 years
|
|
Blood and lymphatic system disorders
Hemoglobin
|
35.3%
6/17 • From time patients went on study to off study, a period of 4 years
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.5%
4/17 • From time patients went on study to off study, a period of 4 years
|
|
Metabolism and nutrition disorders
Hypernatremia
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Vascular disorders
Hypertension
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
17.6%
3/17 • From time patients went on study to off study, a period of 4 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
29.4%
5/17 • From time patients went on study to off study, a period of 4 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
11.8%
2/17 • From time patients went on study to off study, a period of 4 years
|
|
Vascular disorders
Hypotension
|
11.8%
2/17 • From time patients went on study to off study, a period of 4 years
|
|
Psychiatric disorders
Insomnia
|
29.4%
5/17 • From time patients went on study to off study, a period of 4 years
|
|
Blood and lymphatic system disorders
Leukocytes
|
35.3%
6/17 • From time patients went on study to off study, a period of 4 years
|
|
Blood and lymphatic system disorders
Lymphopenia
|
47.1%
8/17 • From time patients went on study to off study, a period of 4 years
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory-Other
|
17.6%
3/17 • From time patients went on study to off study, a period of 4 years
|
|
Psychiatric disorders
Mood alteration
|
23.5%
4/17 • From time patients went on study to off study, a period of 4 years
|
|
Gastrointestinal disorders
Mouth dryness
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Gastrointestinal disorders
Nausea
|
52.9%
9/17 • From time patients went on study to off study, a period of 4 years
|
|
Nervous system disorders
Neurology-Other
|
11.8%
2/17 • From time patients went on study to off study, a period of 4 years
|
|
Nervous system disorders
Neuropathy-sensory
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Blood and lymphatic system disorders
Neutophils/Granulocytes
|
29.4%
5/17 • From time patients went on study to off study, a period of 4 years
|
|
Blood and lymphatic system disorders
Platelets
|
41.2%
7/17 • From time patients went on study to off study, a period of 4 years
|
|
Skin and subcutaneous tissue disorders
Prutitus
|
35.3%
6/17 • From time patients went on study to off study, a period of 4 years
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
General disorders
Rigors,Chills
|
23.5%
4/17 • From time patients went on study to off study, a period of 4 years
|
|
Investigations
SGOT (AST)
|
23.5%
4/17 • From time patients went on study to off study, a period of 4 years
|
|
Investigations
SGPT (ALT)
|
17.6%
3/17 • From time patients went on study to off study, a period of 4 years
|
|
Gastrointestinal disorders
Stomatitis/pharyngitis
|
11.8%
2/17 • From time patients went on study to off study, a period of 4 years
|
|
Gastrointestinal disorders
Taste Disturbance (dysgeusia)
|
5.9%
1/17 • From time patients went on study to off study, a period of 4 years
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
11.8%
2/17 • From time patients went on study to off study, a period of 4 years
|
|
Gastrointestinal disorders
Vomiting
|
23.5%
4/17 • From time patients went on study to off study, a period of 4 years
|
|
Investigations
Weight Loss
|
23.5%
4/17 • From time patients went on study to off study, a period of 4 years
|
Additional Information
Dr. Brian Rini
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Phone: 216-444-9567
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place