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Velcade and Sorafenib in Unresected or Metastatic Renal Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT01100242
Recruitment Status : Terminated (Low accrual)
First Posted : April 8, 2010
Results First Posted : September 17, 2015
Last Update Posted : September 17, 2015
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Renal Cell Carcinoma
Intervention Drug: Velcade and Sorafenib
Enrollment 17
Recruitment Details  
Pre-assignment Details  
Arm/Group Title VELCADE and Sorafenib
Hide Arm/Group Description VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
Period Title: Overall Study
Started 17
Completed 17
Not Completed 0
Arm/Group Title VELCADE and Sorafenib
Hide Arm/Group Description VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
Overall Number of Baseline Participants 17
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 17 participants
61
(44 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants
Female
6
  35.3%
Male
11
  64.7%
1.Primary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression free survival will be measured from the beginning of treatment until there is evidence of progressive disease or death from any cause. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame 36 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VELCADE and Sorafenib
Hide Arm/Group Description:
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
Overall Number of Participants Analyzed 17
Median (Full Range)
Unit of Measure: weeks
13.71
(3.9 to 36.0)
2.Secondary Outcome
Title Overall Response Rate (ORR)
Hide Description Tumor response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (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 rate (ORR) is the percentage of patients who achieve a CR or PR
Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VELCADE and Sorafenib
Hide Arm/Group Description:
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: percentage of participants
Complete response (CR) 0
Partial response (PR) 5.9
Overall response rate (CR + PR) 5.9
3.Secondary Outcome
Title Toxicity Profile
Hide Description Toxicity is assessed using National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 3.0. Toxicity profile is reported as the number of patients who received at least one dose of on-study treatment and experienced a grade 3 or grade 4 adverse event (AE). For a more complete listing of all AEs experienced by patients on study, please see the Adverse Event section.
Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title VELCADE and Sorafenib
Hide Arm/Group Description:
VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One course is comprised of 21 days.
Overall Number of Participants Analyzed 17
Measure Type: Number
Unit of Measure: participants
Abdominal pain 2
Anorexia (loss of appetite) 2
Dehydration 1
Fatigue 2
Hand and foot syndrome 1
Hemoglobin 2
Hyperglycemia 1
Hypertension 1
Hypoalbuminemia 3
Hypokalemia 1
Hyponatremia 5
Hypophosphatemia 4
Lymphopenia 4
Pain - Other (All over body) 1
Pain in extremity 1
Decreased platelets 1
Weight loss 2
Time Frame Up to 42 days following last on-study treatment
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title VELCADE and Sorafenib
Hide Arm/Group Description VELCADE® (bortezomib) 1mg/m2 intravenously on days 1,4,8 & 11 and sorafenib at 200 mg orally twice per day. One full course is comprised of 21 days.
All-Cause Mortality
VELCADE and Sorafenib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
VELCADE and Sorafenib
Affected / at Risk (%) # Events
Total   6/17 (35.29%)    
General disorders   
Chest pain * 1  1/17 (5.88%)  1
Pain - other * 1 [1]  1/17 (5.88%)  1
Hepatobiliary disorders   
Pancreatitis * 1  1/17 (5.88%)  1
Infections and infestations   
Infection - Other * 1 [2]  1/17 (5.88%)  2
Nervous system disorders   
Seizure * 1  1/17 (5.88%)  1
Renal and urinary disorders   
Urinary retention * 1  1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (Shortness of breath) * 1  1/17 (5.88%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Generalized pain all over body required hospitalization
[2]
Folliculitis due to staphylococcus
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
VELCADE and Sorafenib
Affected / at Risk (%) # Events
Total   17/17 (100.00%)    
Blood and lymphatic system disorders   
Blood - Other * 1  1/17 (5.88%)  2
Hemoglobin decreased * 1  8/17 (47.06%)  42
Neutrophils decreased * 1  4/17 (23.53%)  19
Platelets decreased * 1  14/17 (82.35%)  83
Leukocytes decreased * 1  6/17 (35.29%)  56
Lymphopenia * 1  7/17 (41.18%)  95
Cardiac disorders   
Hypertension * 1  6/17 (35.29%)  7
Hypotension * 1  1/17 (5.88%)  1
Arrhythmia supraventricular * 1  1/17 (5.88%)  1
Sinus bradycardia * 1  1/17 (5.88%)  1
Supraventricular tachycardia * 1  1/17 (5.88%)  1
Ventricular tachycardia * 1  1/17 (5.88%)  1
Gastrointestinal disorders   
Ascites * 1  1/17 (5.88%)  1
Abdominal distention * 1  2/17 (11.76%)  2
Anorexia * 1  6/17 (35.29%)  7
Constipation * 1  3/17 (17.65%)  3
Dehydration * 1  3/17 (17.65%)  3
Diarrhea * 1  7/17 (41.18%)  16
Dry mouth * 1  1/17 (5.88%)  1
Dyspepsia * 1  2/17 (11.76%)  2
Mucositis oral * 1  2/17 (11.76%)  2
Nausea * 1  8/17 (47.06%)  11
Taste alteration * 1  4/17 (23.53%)  4
Voice changes * 1  1/17 (5.88%)  1
Vomiting * 1  3/17 (17.65%)  4
Oral hemorrhage * 1  1/17 (5.88%)  1
Cholecystitis * 1  1/17 (5.88%)  1
General disorders   
Allergic reaction * 1  1/17 (5.88%)  2
Fatigue * 1  9/17 (52.94%)  18
Fever * 1  1/17 (5.88%)  1
Weight loss * 1  5/17 (29.41%)  8
Edema limbs * 1  5/17 (29.41%)  6
Ear, nose and throat examination abnormal * 1  1/17 (5.88%)  1
Abdominal pain * 1  5/17 (29.41%)  7
Back pain * 1  1/17 (5.88%)  1
Chest pain * 1  1/17 (5.88%)  2
Chest wall pain * 1  1/17 (5.88%)  1
External ear pain * 1  1/17 (5.88%)  1
Kidney pain * 1  1/17 (5.88%)  1
Pain - Other * 1  2/17 (11.76%)  2
Pain in extremity * 1  5/17 (29.41%)  8
Infections and infestations   
Infection * 1  1/17 (5.88%)  1
Infection, Dental-tooth * 1  1/17 (5.88%)  1
Sinusitis * 1  1/17 (5.88%)  1
Skin infection * 1  1/17 (5.88%)  1
Tooth infection * 1  2/17 (11.76%)  2
Urinary tract infection * 1  1/17 (5.88%)  1
Investigations   
Alanine aminotransferase increased * 1  2/17 (11.76%)  3
Alkaline phosphatase increased * 1  4/17 (23.53%)  8
Aspartate aminotransferase increased * 1  2/17 (11.76%)  4
Creatinine increased * 1  11/17 (64.71%)  26
Hyperbilirubinemia * 1  3/17 (17.65%)  4
Hypercalcemia (high calcium levels in blood) * 1  3/17 (17.65%)  4
Hyperglycemia (high glucose levels in blood) * 1  12/17 (70.59%)  41
Hyperkalemia (high potassium levels in blood) * 1  6/17 (35.29%)  13
Hypermagnesemia (high magnesium levels in blood) * 1  2/17 (11.76%)  2
Hypoalbuminemia (high albumin levels in blood) * 1  12/17 (70.59%)  22
Hypocalcemia (low calcium levels in blood) * 1  8/17 (47.06%)  28
Hypokalemia (low potassium levels in blood) * 1  6/17 (35.29%)  26
Hypomagnesemia (low magnesium levels in blood) * 1  3/17 (17.65%)  6
Hyponatremia (low sodium levels in blood) * 1  12/17 (70.59%)  46
Hypophosphatemia (low phosphate levels in blood) * 1  8/17 (47.06%)  28
Metabolic/Lab - Other * 1 [1]  1/17 (5.88%)  1
Prothombin time increased * 1  1/17 (5.88%)  1
Musculoskeletal and connective tissue disorders   
Muscle weakness * 1  2/17 (11.76%)  2
Muscle weakness - lower limb * 1  1/17 (5.88%)  2
Nervous system disorders   
Dizziness * 1  2/17 (11.76%)  3
Headache * 1  2/17 (11.76%)  2
Peripheral sensory neuropathy * 1  6/17 (35.29%)  7
Renal and urinary disorders   
Urinary incontinence * 1  1/17 (5.88%)  1
Urine discoloration * 1  1/17 (5.88%)  1
Respiratory, thoracic and mediastinal disorders   
Nasal congestion * 1  1/17 (5.88%)  1
Cough * 1  1/17 (5.88%)  1
Dyspnea * 1  1/17 (5.88%)  1
Pleural effusion * 1  1/17 (5.88%)  1
Skin and subcutaneous tissue disorders   
Acne * 1  1/17 (5.88%)  1
Alopecia * 1  4/17 (23.53%)  4
Decubitus * 1  1/17 (5.88%)  1
Dermatology/Skin - Other * 1  3/17 (17.65%)  3
Hand-and-foot syndrome * 1  2/17 (11.76%)  3
Injection site reaction * 1  1/17 (5.88%)  1
Pruritus * 1  4/17 (23.53%)  4
Rash * 1  7/17 (41.18%)  11
Ulceration * 1  1/17 (5.88%)  1
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Elevated lactate dehydrogenase
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Richard Lauer, MD
Organization: University of New Mexico
Phone: 5052725837
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT01100242     History of Changes
Other Study ID Numbers: INST 0812
NCI-2011-02944 ( Registry Identifier: NCI CTRP )
First Submitted: April 6, 2010
First Posted: April 8, 2010
Results First Submitted: June 15, 2015
Results First Posted: September 17, 2015
Last Update Posted: September 17, 2015