Trial Outcomes & Findings for Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma (NCT NCT00193258)
NCT ID: NCT00193258
Last Updated: 2013-01-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
94 participants
Primary outcome timeframe
18 months
Results posted on
2013-01-31
Participant Flow
Participant milestones
| Measure |
Bevacizumab/Erlotinib/Imatinib
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 Study
STARTED
|
94
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bevacizumab, Erlotinib, and Imatinib in the Treatment of Advanced Renal Cell Carcinoma
Baseline characteristics by cohort
| Measure |
Bevacizumab/Erlotinib/Imatinib
n=94 Participants
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
|
|---|---|
|
Age Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
94 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: 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.
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.
Outcome measures
| Measure |
Bevacizumab/Erlotinib/Imatinib
n=88 Participants
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
|
|---|---|
|
Objective Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
|
17 percentage of participants
Interval 9.0 to 26.0
|
PRIMARY outcome
Timeframe: 18 monthsPopulation: All patients enrolled in the trial
Outcome measures
| Measure |
Bevacizumab/Erlotinib/Imatinib
n=94 Participants
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
|
|---|---|
|
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
|
8.9 months
Interval 6.6 to 10.9
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: All patients enrolled in the study
Outcome measures
| Measure |
Bevacizumab/Erlotinib/Imatinib
n=94 Participants
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 Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
|
17.2 months
Interval 12.9 to 21.0
|
Adverse Events
Bevacizumab/Erlotinib/Imatinib
Serious events: 45 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bevacizumab/Erlotinib/Imatinib
n=94 participants at risk
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
|
|---|---|
|
Cardiac disorders
Hypertensive Emergency
|
1.1%
1/94 • Number of events 1
|
|
Vascular disorders
Pulmonary Embolism
|
1.1%
1/94 • Number of events 1
|
|
Infections and infestations
Acute Sepsis Syndrome
|
1.1%
1/94 • Number of events 1
|
|
Gastrointestinal disorders
Large Pericetal Abscess
|
1.1%
1/94 • Number of events 1
|
|
Gastrointestinal disorders
Severe Enteritis with likely bowel perforation
|
1.1%
1/94 • Number of events 1
|
|
Gastrointestinal disorders
Gastritis
|
1.1%
1/94 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
5/94 • Number of events 5
|
|
Nervous system disorders
Spinal Cord compression
|
1.1%
1/94 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Impending pathologic fracture of Right Proximal femur
|
1.1%
1/94 • Number of events 1
|
|
Infections and infestations
Superficial subcutaneous postoperative wound
|
1.1%
1/94 • Number of events 1
|
|
Nervous system disorders
Cerebrovascular Accident
|
2.1%
2/94 • Number of events 3
|
|
Gastrointestinal disorders
Small bowel obstruction
|
1.1%
1/94 • Number of events 1
|
|
Renal and urinary disorders
Acute Renal Failure
|
2.1%
2/94 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Arrest
|
1.1%
1/94 • Number of events 1
|
|
General disorders
Weakness
|
1.1%
1/94 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Progressive Disease
|
6.4%
6/94 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Hip Fracture
|
1.1%
1/94 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Shoulder Pain
|
1.1%
1/94 • Number of events 1
|
|
Surgical and medical procedures
Wedge resection/biopsy of known nodule at left
|
1.1%
1/94 • Number of events 1
|
|
Gastrointestinal disorders
Choleocystitis
|
1.1%
1/94 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.1%
1/94 • Number of events 1
|
|
Infections and infestations
Febrile Neutropenia
|
1.1%
1/94 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rt. pleural effusion
|
1.1%
1/94 • Number of events 1
|
|
Vascular disorders
Subacute Infarct left posterior cerebral artery
|
1.1%
1/94 • Number of events 1
|
|
Gastrointestinal disorders
GU obstruction
|
1.1%
1/94 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxemia
|
1.1%
1/94 • Number of events 1
|
|
Renal and urinary disorders
Acute Renal Insufficiency
|
1.1%
1/94 • Number of events 1
|
|
Cardiac disorders
CHF
|
1.1%
1/94 • Number of events 1
|
|
Infections and infestations
Wound Complication
|
1.1%
1/94 • Number of events 1
|
|
Cardiac disorders
Cardiac Ischemia
|
1.1%
1/94 • Number of events 1
|
|
Gastrointestinal disorders
Fecal Impaction
|
1.1%
1/94 • Number of events 1
|
|
Cardiac disorders
Chest Pain
|
1.1%
1/94 • Number of events 1
|
|
Nervous system disorders
Intercranial Hemorrhage
|
1.1%
1/94 • Number of events 1
|
|
Gastrointestinal disorders
Hemoptysis
|
2.1%
2/94 • Number of events 3
|
|
Renal and urinary disorders
Gross Hematuria
|
1.1%
1/94 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal Ulcer with Bleeding
|
1.1%
1/94 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
4/94 • Number of events 4
|
|
Gastrointestinal disorders
Dehydration
|
4.3%
4/94 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.1%
1/94 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
1.1%
1/94 • Number of events 1
|
Other adverse events
| Measure |
Bevacizumab/Erlotinib/Imatinib
n=94 participants at risk
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
|
|---|---|
|
Immune system disorders
Allergic rhinitis
|
5.3%
5/94 • Number of events 26
|
|
Skin and subcutaneous tissue disorders
Hair Loss/Alopecia
|
23.4%
22/94 • Number of events 72
|
|
Gastrointestinal disorders
Anorexia
|
57.4%
54/94 • Number of events 187
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
19.1%
18/94 • Number of events 33
|
|
General disorders
Rigor/chills
|
9.6%
9/94 • Number of events 16
|
|
Gastrointestinal disorders
Constipation
|
23.4%
22/94 • Number of events 36
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
29.8%
28/94 • Number of events 60
|
|
Gastrointestinal disorders
Cramps (abdominal)
|
8.5%
8/94 • Number of events 14
|
|
Metabolism and nutrition disorders
Creatinine
|
5.3%
5/94 • Number of events 12
|
|
Gastrointestinal disorders
Dehydration
|
12.8%
12/94 • Number of events 16
|
|
Nervous system disorders
Mood Alteration - Depression
|
7.4%
7/94 • Number of events 9
|
|
Gastrointestinal disorders
Diarrhea
|
88.3%
83/94 • Number of events 489
|
|
Nervous system disorders
Dizziness
|
6.4%
6/94 • Number of events 10
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
14.9%
14/94 • Number of events 32
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
24.5%
23/94 • Number of events 60
|
|
Blood and lymphatic system disorders
Edema
|
30.9%
29/94 • Number of events 49
|
|
Vascular disorders
Bleeding
|
31.9%
30/94 • Number of events 77
|
|
General disorders
Fatigue
|
87.2%
82/94 • Number of events 424
|
|
General disorders
Fever
|
16.0%
15/94 • Number of events 21
|
|
Gastrointestinal disorders
Flatulence
|
10.6%
10/94 • Number of events 47
|
|
Nervous system disorders
Headache
|
20.2%
19/94 • Number of events 33
|
|
Renal and urinary disorders
Hematuria
|
16.0%
15/94 • Number of events 48
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
7.4%
7/94 • Number of events 18
|
|
Metabolism and nutrition disorders
Hyperbilirubinemia
|
6.4%
6/94 • Number of events 15
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
17.0%
16/94 • Number of events 45
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.3%
5/94 • Number of events 6
|
|
Immune system disorders
Hypersensitivity
|
5.3%
5/94 • Number of events 9
|
|
Cardiac disorders
Hypertension
|
22.3%
21/94 • Number of events 136
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
6.4%
6/94 • Number of events 18
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.4%
7/94 • Number of events 12
|
|
Infections and infestations
Infection
|
45.7%
43/94 • Number of events 127
|
|
General disorders
Insomnia
|
14.9%
14/94 • Number of events 45
|
|
Gastrointestinal disorders
Mucositis
|
11.7%
11/94 • Number of events 24
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.7%
11/94 • Number of events 15
|
|
Gastrointestinal disorders
Nausea
|
78.7%
74/94 • Number of events 198
|
|
Nervous system disorders
Neuropathy
|
20.2%
19/94 • Number of events 59
|
|
General disorders
Pain
|
19.1%
18/94 • Number of events 35
|
|
Gastrointestinal disorders
Pain (abdominal)
|
6.4%
6/94 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Pain (back)
|
8.5%
8/94 • Number of events 21
|
|
Metabolism and nutrition disorders
Proteinuria
|
73.4%
69/94 • Number of events 288
|
|
Skin and subcutaneous tissue disorders
Rash
|
85.1%
80/94 • Number of events 517
|
|
Respiratory, thoracic and mediastinal disorders
Sinus drainage
|
5.3%
5/94 • Number of events 14
|
|
Skin and subcutaneous tissue disorders
Skin (dry)
|
21.3%
20/94 • Number of events 75
|
|
Skin and subcutaneous tissue disorders
Skin (pruritis)
|
14.9%
14/94 • Number of events 31
|
|
Gastrointestinal disorders
Stomatitis
|
13.8%
13/94 • Number of events 25
|
|
Gastrointestinal disorders
Taste change
|
5.3%
5/94 • Number of events 34
|
|
Gastrointestinal disorders
Taste disturbance
|
38.3%
36/94 • Number of events 129
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.4%
6/94 • Number of events 15
|
|
General disorders
Weight Loss
|
28.7%
27/94 • Number of events 92
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
5.3%
5/94 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.4%
7/94 • Number of events 11
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER