Trial Outcomes & Findings for Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer (NCT NCT00126490)

Last Updated: 2015-06-30

Results Overview

Major response according to Response Evaluation Criteria In Solid Tumors (RECIST). CR: Disappearance of all target lesions; Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

1 year

Results posted on

2015-06-30

Participant Flow

The recruitment period began 03/23/2005 and accrual was closed 8/21/2007 due to slow accrual.

24 enrolled but 5 were never treated (moved away, creatinine too high, Hospice before starting, lived too far away to come, chromophobe subtype after review of pathology)

Participant milestones

Participant milestones
Measure	Treatment (Bevacizumab, Aldesleukin) Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	19
Overall Study COMPLETED	18
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment (Bevacizumab, Aldesleukin) Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Overall Study Stopped after 1 infusion (fall/injury)	1

Baseline Characteristics

Bevacizumab and Interleukin-2 in Treating Patients With Metastatic Kidney Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment (Bevacizumab, Aldesleukin) n=18 Participants Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants
Age, Categorical >=65 years	9 Participants n=5 Participants
Age, Continuous	66 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment United States	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: All Participants who received at least one treatment

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Aldesleukin) n=19 Participants Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year Complete Response	0 participants Interval 0.0 to 0.0
Number of Evaluable Participants With Complete Response (CR) and Partial Response (PR) at One Year Partial Response	1 participants Interval 0.1 to 26.0

SECONDARY outcome

Timeframe: 2 years from start of treatment

Population: Evaluable participants

Overall Survival tabulation at 2 years from start of treatment.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Aldesleukin) n=18 Participants Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
Number of Evaluable Participants With Overall Survival (OS) at 2 Years	10 participants

SECONDARY outcome

Timeframe: Up to 2 years

Population: Evaluable participants

Progression Free Survival tabulation at 1 year and at 2 years. Progressive Disease (PD): Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Aldesleukin) n=18 Participants Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
Number of Evaluable Participants With Progression Free Survival (PFS) PFS at 1 year	3 participants
Number of Evaluable Participants With Progression Free Survival (PFS) PFS at 2 years	1 participants

SECONDARY outcome

Timeframe: At baseline, at days 4-5, 9-10 (of course 1), and at the end of treatment

Population: This was not evaluable because there were not enough samples.

Dendritic cell (DC) phenotype or functionality. Pearson correlation coefficients of DC:ImC ratio with DC function were to be computed and tested for departure from zero. Those with major responses were to be compared to those without major responses with respect to baseline DC:ImC ratio, baseline DC functional assay, post-treatment DC:ImC ratio and post-treatment DC functional assay using pooled t tests.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days after completion of treatment

Population: All Participants who received at least one treatment

Number of Participants with Serious Adverse Events (SAEs) Possibly Related to Study Treatment. Toxicity as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 3.0

Outcome measures

Outcome measures
Measure	Treatment (Bevacizumab, Aldesleukin) n=19 Participants Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
Number of Participants With Possibly Related Serious Adverse Events (SAEs)	4 participants

Adverse Events

Treatment (Bevacizumab, Aldesleukin)

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment (Bevacizumab, Aldesleukin) n=19 participants at risk Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
General disorders Fever (in the absence of neutropenia)	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
General disorders Death not associated with CTCAE term	10.5% 2/19 • Number of events 2 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Endocrine disorders Thyroid function low, (hypothyroidism)	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Gastrointestinal disorders Dehydration	21.1% 4/19 • Number of events 4 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Gastrointestinal disorders Nausea	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Gastrointestinal disorders Ulcer, GI - Stomach	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Gastrointestinal disorders Vomiting	10.5% 2/19 • Number of events 2 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Gastrointestinal disorders Hemorrhage, GI	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Infections and infestations Infection with normal ANC or Grade 1 or 2 neutrophils - Bone (osteomyelitis)	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Metabolism and nutrition disorders Calcium, serum-high (hypercalcemia)	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Musculoskeletal and connective tissue disorders Fracture	5.3% 1/19 • Number of events 2 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Musculoskeletal and connective tissue disorders Muscle weakness, generalized or specific area (not due to neuropathy) - Trunk	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Psychiatric disorders Confusion	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Nervous system disorders Dizziness	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Nervous system disorders Neuropathy: motor	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
General disorders Pain - Joint	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Nervous system disorders Pain - Neuralgia/peripheral nerve	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Respiratory, thoracic and mediastinal disorders Dyspnea (shortness of breath)	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Respiratory, thoracic and mediastinal disorders Pneumonitis/pulmonary infiltrates	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.
Investigations Secondary Malignancy - possibly related to cancer treatment	5.3% 1/19 • Number of events 1 • 2 years "0" had to be entered for Other (not including Serious) Adverse Events, because they were not tabulated for treatment 3/30/05 through 1/24/07.

Other adverse events

Adverse event data not reported

Additional Information

Mayer Fishman, M.D., Ph.D.

H. Lee Moffitt Cancer Center and Research Institute

Phone: 813-745-8311

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60