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Trial record 2 of 10 for:    "Clear Cell Renal Cell Carcinoma" | "Interferon alpha-2"

A Study of Avastin (Bevacizumab) in Combination With Low-Dose-Interferon in Patients With Metastatic Clear Cell Renal Cell Carcinoma (RCC).

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: NCT00796757
Recruitment Status : Completed
First Posted : November 24, 2008
Results First Posted : May 27, 2015
Last Update Posted : May 27, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Renal Cell Cancer
Interventions Drug: bevacizumab [Avastin]
Drug: interferon alfa-2a
Enrollment 146
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab Plus (+) Interferon
Hide Arm/Group Description Participants received bevacizumab 5 milligrams per kilogram (mg/kg) intravenously (IV) on Day 1 and Interferon alpha-2a (IFN) 3 million international units (MIU) subcutaneously (SC) 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Period Title: Overall Study
Started 146
Completed 60
Not Completed 86
Reason Not Completed
Withdrawal by Subject             14
Death             61
Protocol Violation             1
Participant noncompliance             1
Investigator's decision             2
Not specified             7
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Baseline Participants 146
Hide Baseline Analysis Population Description
Intent-to-treat (ITT) population: All participants who received at least 1 dose of either or both study drugs and had a valid baseline assessment and at least 1 postbaseline assessment.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants
61.1  (10.37)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Female
48
  32.9%
Male
98
  67.1%
1.Primary Outcome
Title Progression-Free Survival (PFS) - Percentage of Participants Estimated to be Progression Free at 12 and 24 Months
Hide Description PFS at 12 and 24 months is an estimate of the percentages of participants expected to be progression free at 12 and 24 months based on Kaplan-Meier survival analysis of the PFS data. PFS was defined as the time period from the first postbaseline tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time Frame 12 and 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 146
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12 months
58.2
(49.9 to 66.6)
24 months
28.9
(20.8 to 36.9)
2.Primary Outcome
Title PFS - Percentage of Participants With an Event
Hide Description PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time Frame Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
69.2
3.Primary Outcome
Title PFS - Time to Event
Hide Description PFS was defined as the time period from the first postbaseline assessment tumor assessment to evidence of disease progression or death from any cause, whichever occurred first. Disease progression included evaluation solely due to symptomatic deterioration or death due to any reason. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time Frame Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 146
Median (95% Confidence Interval)
Unit of Measure: months
15.3
(11.7 to 18.0)
4.Secondary Outcome
Title Percentage of Participants With a Best Overall Response of Complete Reponse (CR) or Partial Response (PR)
Hide Description Percentage of participants with objective response, termed responders, based assessment of confirmed CR or confirmed PR according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed responses were those that persisted on repeat imaging study greater than or equal to (≥)4 weeks after initial documentation of response. CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]). No new lesions. PR was defined as ≥30 percent (%) decrease under baseline of the sum of diameters of all target lesions. The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions.
Time Frame Baseline, every 8 weeks to Week 32 then every 12 weeks to disease progression or a maximum of 2 years from enrollment of last participant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; only participants with measurable disease were included in the analysis.
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 139
Measure Type: Number
Unit of Measure: percentage of participants
28.8
5.Secondary Outcome
Title Overall Survival (OS) - Percentage of Participants Estimated to be Alive at 12 and 24 Months
Hide Description OS at 12 and 24 months is the estimate of the percentages of participants expected to alive at 12 and 24 months based on Kaplan-Meier survival analysis of the survival data. Median OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time Frame Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 146
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
12 months
84.1
(78.0 to 90.2)
24 months
59.6
(51.0 to 68.2)
6.Secondary Outcome
Title OS - Percentage of Participants With an Event
Hide Description OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time Frame Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
41.8
7.Secondary Outcome
Title OS - Time to Event
Hide Description OS was defined as the time period from the first bevacizumab infusion to death from any cause. Censoring at start of any subsequent antineoplastic therapy was not performed.
Time Frame Day 0, every 2 weeks until disease progression or end of treatment visit (28 days after last bevacizumab infusion, every 3 months during follow-up, or a maximum of 2 years from enrollment of last participant
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 146
Median (95% Confidence Interval)
Unit of Measure: months
30.7 [1] 
(25.7 to NA)
[1]
The upper limit of the 95% confidence interval (CI) could not be estimated because the follow-up time was too short to observe enough survival events for complete data estimation.
8.Secondary Outcome
Title Percentage of Participants With Any Health Problems as Assessed by the European Quality of Life 5 Dimensions (EQ-5D) by Visit
Hide Description EQ-5D is a standardized, participant-administered measure of health outcome. It provides a descriptive profile for 5 dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), using 3 levels (no, moderate, or extreme problems) and a single index value characterizing current health status using a 100-point visual analog scale (0=worst, 100=best). Answers from the questionnaire for each dimension (mobility, self-care, usual activity, pain/discomfort, and anxiety/depression) was classified into one of 2 categories: 'no problems' or 'any problems', and the percentage of participants in each category was determined.
Time Frame Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and End of Treatment (EOT)
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; number (n) equals (=) number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 145
Measure Type: Number
Unit of Measure: percentage of participants
Mobility, no problems, Baseline (n=142) 69.0
Mobility, any problems, Baseline (n=142) 31.0
Mobility, no problems, Cycle 7 (n=106) 64.2
Mobility, any problems, Cycle 7 (n=106) 35.8
Mobility, no problems, Cycle 25 (n=69) 58.0
Mobility, any problems, Cycle 25 (n=69) 42.0
Mobility, no problems, Cycle 43 (n=36) 38.9
Mobility, any problems, Cycle 43 (n=36) 61.1
Mobility, no problems, Cycle 61 (n=22) 40.9
Mobility, any problems, Cycle 61 (n=22) 59.1
Mobility, no problems, EOT (n=82) 41.3
Mobility, any problems, EOT (n=82) 58.8
Self-care, no problems, Baseline (n=145) 82.8
Self-care, any problems, Baseline (n=145) 17.2
Self-care, no problems, Cycle 7 (n=106) 81.1
Self-care, any problems, Cycle 7 (n=106) 18.9
Self-care, no problems, Cycle 25 (n=69) 81.2
Self-care, any problems, Cycle 25 (n=69) 18.8
Self-care, no problems, Cycle 43 (n=36) 69.4
Self-care, any problems, Cycle 43 (n=36) 30.6
Self-care, no problems, Cycle 61 (n=22) 77.3
Self-care, any problems, Cycle 61 (n=22) 22.7
Self-care, no problems, EOT (n=80) 63.8
Self-care, any problems, EOT (n=80) 36.3
Usual activity, no problems, Baseline (n=145) 60.7
Usual activity, any problems, Baseline (n=145) 39.3
Usual activity, no problems, Cycle 7 (n=106) 53.8
Usual activity, any problems, Cycle 7 (n=106) 46.2
Usual activity, no problems, Cycle 25 (n=69) 46.4
Usual activity, any problems, Cycle 25 (n=69) 53.6
Usual activity, no problems, Cycle 43 (n=36) 33.3
Usual activity, any problems, Cycle 43 (n=36) 66.7
Usual activity, no problems, Cycle 61 (n=22) 45.5
Usual activity, any problems, Cycle 61 (n=22) 54.5
Usual activity, no problems, EOT (n=78) 33.3
Usual activity, any problems, EOT (n=78) 66.7
Pain/discomfort, no problems, Baseline (n=145) 48.3
Pain/discomfort, any problems, Baseline (n=145) 51.7
Pain/discomfort, no problems, Cycle 7 (n=106) 49.1
Pain/discomfort, any problems, Cycle 7 (n=106) 50.9
Pain/discomfort, no problems, Cycle 25 (n=69) 53.6
Pain/discomfort, any problems, Cycle 25 (n=69) 46.4
Pain/discomfort, no problems, Cycle 43 (n=36) 50.0
Pain/discomfort, any problems, Cycle 43 (n=36) 50.0
Pain/discomfort, no problems, Cycle 61 (n=22) 50.0
Pain/discomfort, any problems, Cycle 61 (n=22) 50.0
Pain/discomfort, no problems, EOT (n=80) 33.8
Pain/discomfort, any problems, EOT (n=80) 66.3
Anxiety/depression, no problems, Baseline (n=144) 45.8
Anxiety/depression, any problems, Baseline (n=144) 54.2
Anxiety/depression, no problems, Cycle 7 (n=106) 55.7
Anxiety/depression, any problems, Cycle 7 (n=106) 44.3
Anxiety/depression, no problems, Cycle 25 (n=69) 62.3
Anxiety/depression, any problems, Cycle 25 (n=69) 37.7
Anxiety/depression, no problems, Cycle 43 (n=36) 61.1
Anxiety/depression, any problems, Cycle 43 (n=36) 38.9
Anxiety/depression, no problems, Cycle 61 (n=22) 59.1
Anxiety/depression, any problems, Cycle 61 (n=22) 40.9
Anxiety/depression, no problems, EOT (n=80) 45.0
Anxiety/depression, any problems, EOT (n=80) 55.0
9.Secondary Outcome
Title EQ-5D - Visual Analog Scale (VAS)
Hide Description EQ-5D: participant-rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 millimeters (mm) (best imaginable health state); higher scores indicate a better health state. Participants were asked to rate their health state and mark the line; the distance from the left edge was recorded. For change from baseline a negative value represents a worsening in the health state and a positive value represents an improvement in the health state.
Time Frame Screening/Baseline, Cycle 7, Cycle 25, Cycle 43, Cycle 61, and EOT
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population; n=number of participants assessed for the specified parameter at a given visit.
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description:
Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
Overall Number of Participants Analyzed 140
Mean (Standard Deviation)
Unit of Measure: mm
Baseline (n=140) 71.2  (17.27)
Cycle 7 (n=103) 71.8  (13.63)
Change at Cycle 7 (n=99) -1.8  (14.54)
Cycle 25 (n=68) 72.4  (15.46)
Change at Cycle 25 (n=67) -2.3  (17.84)
Cycle 43 (n=36) 71.3  (17.12)
Change at Cycle 43 (n=36) -0.9  (20.12)
Cycle 61 (n=22) 70.5  (15.74)
Change at Cycle 61 (n=22) -1.7  (20.41)
EOT (n=79) 65.2  (19.72)
Change at EOT (n=77) -7.7  (15.73)
Time Frame Adverse events (AEs) were recorded from the date of first administration of bevacizumab until 28 days after the last administration of bevacizumab and/or IFN.
Adverse Event Reporting Description All Grade >3 AEs documented. Only Grade 1/2 AEs related to bevacizumab and/or IFN occurring from first bevacizumab administration up to 28 days after last dose were documented.
 
Arm/Group Title Bevacizumab + Interferon
Hide Arm/Group Description Participants received bevacizumab 5 mg/kg IV on Day 1 and IFN 3 MIU SC 3 times per week with at least 1 day between injections. This cycle lasted for 2 weeks and was repeated until disease progression, unacceptable toxicity, or participant withdrawal.
All-Cause Mortality
Bevacizumab + Interferon
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab + Interferon
Affected / at Risk (%)
Total   26/146 (17.81%) 
Cardiac disorders   
Cardiac arrest * 1  1/146 (0.68%) 
Endocrine disorders   
Hyperthyroidism * 1  1/146 (0.68%) 
Inappropriate antidiuretic hormone secretion * 1  1/146 (0.68%) 
Gastrointestinal disorders   
Vomiting * 1  1/146 (0.68%) 
Haemorrhoids * 1  1/146 (0.68%) 
Rectal haemorrhage * 1  1/146 (0.68%) 
General disorders   
Asthenia * 1  3/146 (2.05%) 
Fatigue * 1  1/146 (0.68%) 
Pyrexia * 1  1/146 (0.68%) 
Immune system disorders   
Drug hypersensitivity * 1  1/146 (0.68%) 
Infections and infestations   
Abscess * 1  1/146 (0.68%) 
Cystitis * 1  1/146 (0.68%) 
Erysipelas * 1  1/146 (0.68%) 
Peritonsillar abscess * 1  1/146 (0.68%) 
Respiratory tract infection * 1  1/146 (0.68%) 
Injury, poisoning and procedural complications   
Overdose * 1  1/146 (0.68%) 
Skull fracture * 1  1/146 (0.68%) 
Spinal fracture * 1  1/146 (0.68%) 
Metabolism and nutrition disorders   
Hypercalcaemia * 1  1/146 (0.68%) 
Hyponatraemia * 1  2/146 (1.37%) 
Electrolyte imbalance * 1  1/146 (0.68%) 
Nervous system disorders   
Syncope * 1  2/146 (1.37%) 
Headache * 1  1/146 (0.68%) 
Cerebral haemorrhage * 1  1/146 (0.68%) 
Cerebrovascular stenosis * 1  1/146 (0.68%) 
Haemorrhage intracranial * 1  1/146 (0.68%) 
Loss of consciousness * 1  1/146 (0.68%) 
Paraesthesia * 1  1/146 (0.68%) 
Psychiatric disorders   
Depression * 1  1/146 (0.68%) 
Panic attack * 1  1/146 (0.68%) 
Respiratory, thoracic and mediastinal disorders   
Chronic obstructive pulmonary disease * 1  1/146 (0.68%) 
Vascular disorders   
Hypertension * 1  2/146 (1.37%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab + Interferon
Affected / at Risk (%)
Total   113/146 (77.40%) 
Blood and lymphatic system disorders   
Thrombocytopenia * 1  16/146 (10.96%) 
Neutropenia * 1  8/146 (5.48%) 
Leukopenia * 1  10/146 (6.85%) 
Gastrointestinal disorders   
Nausea * 1  13/146 (8.90%) 
Diarrhoea * 1  13/146 (8.90%) 
Vomiting * 1  10/146 (6.85%) 
Stomatitis * 1  10/146 (6.85%) 
General disorders   
Pyrexia * 1  28/146 (19.18%) 
Fatigue * 1  41/146 (28.08%) 
Asthenia * 1  15/146 (10.27%) 
Chills * 1  13/146 (8.90%) 
Infections and infestations   
Nasopharyngitis * 1  8/146 (5.48%) 
Investigations   
Weight decreased * 1  8/146 (5.48%) 
Blood creatinine increased * 1  8/146 (5.48%) 
Metabolism and nutrition disorders   
Decreased appetite * 1  17/146 (11.64%) 
Nervous system disorders   
Headache * 1  21/146 (14.38%) 
Renal and urinary disorders   
Proteinuria * 1  63/146 (43.15%) 
Respiratory, thoracic and mediastinal disorders   
Epistaxis * 1  20/146 (13.70%) 
Vascular disorders   
Hypertension * 1  51/146 (34.93%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The Study being conducted under this agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request the Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-LaRoche
Phone: 800-821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00796757     History of Changes
Other Study ID Numbers: MO21609
2007-006611-23
First Submitted: November 21, 2008
First Posted: November 24, 2008
Results First Submitted: August 4, 2014
Results First Posted: May 27, 2015
Last Update Posted: May 27, 2015