Trial Outcomes & Findings for Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy (NCT NCT00104871)
NCT ID: NCT00104871
Last Updated: 2018-12-19
Results Overview
Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
24 participants
Primary outcome timeframe
Baseline to 12 weeks
Results posted on
2018-12-19
Participant Flow
Recruitment Period: December 2004 to April 2010. Recruitment done in medical clinics.
Of the 24 participants enrolled, two participants were not eligible and excluded from the study.
Participant milestones
| Measure |
Bortezomib
Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Bortezomib
Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
|
|---|---|
|
Overall Study
Not evaluable
|
1
|
Baseline Characteristics
Bortezomib in Treating Patients With Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
Baseline characteristics by cohort
| Measure |
Bortezomib
n=22 Participants
Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
|
|---|---|
|
Age, Continuous
|
62 years
n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeksPopulation: Two participants were not evaluable for response.
Response Rate calculated as number of participants with Complete or Partial Response divided by total participants. Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Bortezomib
n=20 Participants
Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
|
|---|---|
|
Objective Tumor Response Rate Assessed by RECIST
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline to 12 weeks (minimum of 4 treatment cycles (or 12 weeks))Population: Two participants were not evaluable for response.
Baseline scan and confirmatory scans obtained 6 weeks following initial documentation of objective response using Response Evaluation Criteria in Solid Tumors (RECIST). Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): \>30% decrease in sum longest diameter (LD) of target lesions, taking as reference the baseline sum LD; Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started.
Outcome measures
| Measure |
Bortezomib
n=20 Participants
Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
|
|---|---|
|
Participant Tumor Response Assessed by RECIST
Complete Response
|
0 participants
|
|
Participant Tumor Response Assessed by RECIST
Partial Response
|
0 participants
|
|
Participant Tumor Response Assessed by RECIST
Stable Disease
|
11 participants
|
|
Participant Tumor Response Assessed by RECIST
Progressive Disease
|
9 participants
|
SECONDARY outcome
Timeframe: At 6 monthsPopulation: Two participants were not evaluable for response.
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 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
Outcome measures
| Measure |
Bortezomib
n=20 Participants
Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
|
|---|---|
|
Progression-free Survival Assessed by RECIST
|
4 Participants
|
Adverse Events
Bortezomib
Serious events: 17 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bortezomib
n=22 participants at risk
Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
|
|---|---|
|
General disorders
Abdominal pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Blood and lymphatic system disorders
Anemia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Anorexia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Ascites
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Ataxia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Cardiac disorders
Atrial flutter
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial infection
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Constipation
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
General disorders
Death NOS
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Dysphasia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
General disorders
Fatigue
|
18.2%
4/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Cardiac disorders
Heart failure
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Vascular disorders
Hypotension
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Psychiatric disorders
Insomnia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Investigation: Hypoalbuminemia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Infections and infestations
Lung infection
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Lymphocyte count decreased
|
18.2%
4/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Neuralgia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Oral pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Cardiac disorders
Supraventricular tachycardia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Syncope
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Vascular disorders
Thromboembolic event
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Weight loss
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
Other adverse events
| Measure |
Bortezomib
n=22 participants at risk
Bortezomib 1.3 mg/m\^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Acidosis
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Alanine aminotransferase increased
|
13.6%
3/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Alkaline phosphatase increased
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Blood and lymphatic system disorders
Anemia
|
27.3%
6/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Anorexia
|
31.8%
7/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Psychiatric disorders
Anxiety
|
18.2%
4/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Aspartate aminotransferase increased
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.6%
3/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Blood bilirubin increased
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Eye disorders
Blurred vision
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Skin and subcutaneous tissue disorders
Body odor
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary hemorrhage
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Injury, poisoning and procedural complications
Bruising
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Cognitive disturbance
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Psychiatric disorders
Confusion
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Eye disorders
Conjunctivitis
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Constipation
|
54.5%
12/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
22.7%
5/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Creatinine increased
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Diarrhea
|
40.9%
9/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Dizziness
|
22.7%
5/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Dysgeusia
|
22.7%
5/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Dyspepsia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
22.7%
5/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
General disorders
Edema face
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
General disorders
Edema limbs
|
13.6%
3/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
General disorders
Edema trunk
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Extrapyramidal disorder
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Eye disorders
Eye disorders - (Other)
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Infections and infestations
Eye infection
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Eye disorders
Eyelid function disorder
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
General disorders
Fatigue
|
77.3%
17/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Fever
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Eye disorders
Flashing Lights
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
13.6%
3/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Headache
|
27.3%
6/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Hemorrhoids
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Reproductive system and breast disorders
Hot flashes
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
36.4%
8/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Vascular disorders
Hypertension
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
18.2%
4/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.6%
3/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Vascular disorders
Hypotension
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Endocrine disorders
Hypothyroidism
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Infections and infestations
Infections and infestations - (Other)
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
General disorders
Injection site reaction
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Psychiatric disorders
Insomnia
|
27.3%
6/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Investigations - (Other)
|
13.6%
3/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Lymphocyte count decreased
|
27.3%
6/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Nausea
|
45.5%
10/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Neuralgia
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Neutrophil count decreased
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
General disorders
Non-cardiac chest pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Oral pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
General disorders
Pain, Body
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Musculoskeletal and connective tissue disorders
Pain, Knee
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Skin and subcutaneous tissue disorders
Pain, Dermis
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Hepatobiliary disorders
Gallbladder pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Cardiac disorders
Palpitations
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
36.4%
8/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Platelet count decreased
|
22.7%
5/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.6%
3/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Psychiatric disorders
Psychosis
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
40.9%
9/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Infections and infestations
Rhinitis infective
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus disorder
|
9.1%
2/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Stomach pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Reproductive system and breast disorders
Testicular pain
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Toothache
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Eye disorders
Uveitis
|
4.5%
1/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Gastrointestinal disorders
Vomiting
|
27.3%
6/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
Weight loss
|
27.3%
6/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
|
Investigations
White blood cell decreased
|
13.6%
3/22 • Participants followed for duration of treatment time to disease progression. Overall study period was from January 20, 2005 to May 14, 2010.
|
Additional Information
Steven Sherman, MD / Professor
UT MD Anderson Cancer Center
Phone: 713-792-2841
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60