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Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00193258
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : January 14, 2013
Last Update Posted : January 31, 2013
Sponsor:
Collaborators:
Genentech, Inc.
Novartis
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Clear Cell Renal Cell Carcinoma
Interventions Drug: Bevacizumab
Drug: Erlotinib
Drug: Imatinib
Enrollment 94
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab/Erlotinib/Imatinib
Hide Arm/Group Description In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
Period Title: Overall Study
Started 94
Completed 94
Not Completed 0
Arm/Group Title Bevacizumab/Erlotinib/Imatinib
Hide Arm/Group Description In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
Overall Number of Baseline Participants 94
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 94 participants
60
(39 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants
Female
20
  21.3%
Male
74
  78.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 94 participants
94
1.Primary Outcome
Title Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: 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 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Eighty-seven of 94 patients (93%) received ≥ 2 months of treatment and were fully evaluable for response. Seven patients discontinued treatment during the first 8 weeks. One of these 7 patients had evidence of rapid tumor progression, whereas the remaining 6 patients discontinued treatment because of toxicity or for personal reasons.
Arm/Group Title Bevacizumab/Erlotinib/Imatinib
Hide Arm/Group Description:
In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
Overall Number of Participants Analyzed 88
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
17
(9 to 26)
2.Primary Outcome
Title Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Hide Description [Not Specified]
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the trial
Arm/Group Title Bevacizumab/Erlotinib/Imatinib
Hide Arm/Group Description:
In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
Overall Number of Participants Analyzed 94
Median (95% Confidence Interval)
Unit of Measure: months
8.9
(6.6 to 10.9)
3.Primary Outcome
Title Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients enrolled in the study
Arm/Group Title Bevacizumab/Erlotinib/Imatinib
Hide Arm/Group Description:
In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
Overall Number of Participants Analyzed 94
Median (95% Confidence Interval)
Unit of Measure: months
17.2
(12.9 to 21)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab/Erlotinib/Imatinib
Hide Arm/Group Description In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
All-Cause Mortality
Bevacizumab/Erlotinib/Imatinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab/Erlotinib/Imatinib
Affected / at Risk (%) # Events
Total   45/94 (47.87%)    
Cardiac disorders   
Hypertensive Emergency  1  1/94 (1.06%)  1
CHF  1  1/94 (1.06%)  1
Cardiac Ischemia  1  1/94 (1.06%)  1
Chest Pain  1  1/94 (1.06%)  1
Gastrointestinal disorders   
Large Pericetal Abscess  1  1/94 (1.06%)  1
Severe Enteritis with likely bowel perforation  1  1/94 (1.06%)  1
Gastritis  1  1/94 (1.06%)  1
Vomiting  1  5/94 (5.32%)  5
Small bowel obstruction  1  1/94 (1.06%)  1
Choleocystitis  1  1/94 (1.06%)  1
GU obstruction  1  1/94 (1.06%)  1
Fecal Impaction  1  1/94 (1.06%)  1
Hemoptysis  1  2/94 (2.13%)  3
Duodenal Ulcer with Bleeding  1  1/94 (1.06%)  1
Diarrhea  1  4/94 (4.26%)  4
Dehydration  1  4/94 (4.26%)  5
General disorders   
Weakness  1  1/94 (1.06%)  1
Infections and infestations   
Acute Sepsis Syndrome  1  1/94 (1.06%)  1
Superficial subcutaneous postoperative wound  1  1/94 (1.06%)  1
Febrile Neutropenia  1  1/94 (1.06%)  1
Wound Complication  1  1/94 (1.06%)  1
Metabolism and nutrition disorders   
Hypercalcemia  1  1/94 (1.06%)  1
Musculoskeletal and connective tissue disorders   
Impending pathologic fracture of Right Proximal femur  1  1/94 (1.06%)  1
Hip Fracture  1  1/94 (1.06%)  2
Shoulder Pain  1  1/94 (1.06%)  1
Back Pain  1  1/94 (1.06%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Progressive Disease  1  6/94 (6.38%)  6
Nervous system disorders   
Spinal Cord compression  1  1/94 (1.06%)  1
Cerebrovascular Accident  1  2/94 (2.13%)  3
Intercranial Hemorrhage  1  1/94 (1.06%)  1
Renal and urinary disorders   
Acute Renal Failure  1  2/94 (2.13%)  2
Acute Renal Insufficiency  1  1/94 (1.06%)  1
Gross Hematuria  1  1/94 (1.06%)  2
Respiratory, thoracic and mediastinal disorders   
Respiratory Arrest  1  1/94 (1.06%)  1
Rt. pleural effusion  1  1/94 (1.06%)  1
Hypoxemia  1  1/94 (1.06%)  1
Dyspnea  1  1/94 (1.06%)  1
Surgical and medical procedures   
Wedge resection/biopsy of known nodule at left  1  1/94 (1.06%)  1
Vascular disorders   
Pulmonary Embolism  1  1/94 (1.06%)  1
Subacute Infarct left posterior cerebral artery  1  1/94 (1.06%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Bevacizumab/Erlotinib/Imatinib
Affected / at Risk (%) # Events
Total   83/94 (88.30%)    
Blood and lymphatic system disorders   
Edema  1  29/94 (30.85%)  49
Thrombocytopenia  1  6/94 (6.38%)  15
Cardiac disorders   
Hypertension  1  21/94 (22.34%)  136
Gastrointestinal disorders   
Anorexia  1  54/94 (57.45%)  187
Constipation  1  22/94 (23.40%)  36
Cramps (abdominal)  1  8/94 (8.51%)  14
Dehydration  1  12/94 (12.77%)  16
Diarrhea  1  83/94 (88.30%)  489
Heartburn/dyspepsia  1  14/94 (14.89%)  32
Flatulence  1  10/94 (10.64%)  47
Mucositis  1  11/94 (11.70%)  24
Nausea  1  74/94 (78.72%)  198
Pain (abdominal)  1  6/94 (6.38%)  9
Stomatitis  1  13/94 (13.83%)  25
Taste change  1  5/94 (5.32%)  34
Taste disturbance  1  36/94 (38.30%)  129
General disorders   
Rigor/chills  1  9/94 (9.57%)  16
Fatigue  1  82/94 (87.23%)  424
Fever  1  15/94 (15.96%)  21
Insomnia  1  14/94 (14.89%)  45
Pain  1  18/94 (19.15%)  35
Weight Loss  1  27/94 (28.72%)  92
Immune system disorders   
Allergic rhinitis  1  5/94 (5.32%)  26
Hypersensitivity  1  5/94 (5.32%)  9
Infections and infestations   
Infection  1  43/94 (45.74%)  127
Metabolism and nutrition disorders   
Creatinine  1  5/94 (5.32%)  12
Hyperbilirubinemia  1  6/94 (6.38%)  15
Hyperglycemia  1  16/94 (17.02%)  45
Hyperkalemia  1  5/94 (5.32%)  6
Hyperuricemia  1  6/94 (6.38%)  18
Hyponatremia  1  7/94 (7.45%)  12
Proteinuria  1  69/94 (73.40%)  288
Hypocalcemia  1  5/94 (5.32%)  5
Hypokalemia  1  7/94 (7.45%)  11
Musculoskeletal and connective tissue disorders   
Arthralgia  1 [1]  18/94 (19.15%)  33
Myalgia  1  11/94 (11.70%)  15
Pain (back)  1  8/94 (8.51%)  21
Nervous system disorders   
Mood Alteration - Depression  1  7/94 (7.45%)  9
Dizziness  1  6/94 (6.38%)  10
Headache  1  19/94 (20.21%)  33
Neuropathy  1  19/94 (20.21%)  59
Renal and urinary disorders   
Hematuria  1  15/94 (15.96%)  48
Respiratory, thoracic and mediastinal disorders   
Cough  1  28/94 (29.79%)  60
Dyspnea  1  23/94 (24.47%)  60
Hoarseness  1  7/94 (7.45%)  18
Sinus drainage  1  5/94 (5.32%)  14
Skin and subcutaneous tissue disorders   
Hair Loss/Alopecia  1  22/94 (23.40%)  72
Rash  1  80/94 (85.11%)  517
Skin (dry)  1  20/94 (21.28%)  75
Skin (pruritis)  1  14/94 (14.89%)  31
Vascular disorders   
Bleeding  1  30/94 (31.91%)  77
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Arthralgia
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 sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00193258     History of Changes
Other Study ID Numbers: SCRI GU 22
First Submitted: September 12, 2005
First Posted: September 19, 2005
Results First Submitted: December 7, 2012
Results First Posted: January 14, 2013
Last Update Posted: January 31, 2013