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Trial record 36 of 228 for:    "Anaplastic oligodendroglioma"

A Randomized Phase II Trial of Vandetanib (ZD6474) in Combination With Carboplatin Versus Carboplatin Alone Followed by Vandetanib Alone in Adults With Recurrent High-Grade Gliomas

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ClinicalTrials.gov Identifier: NCT00995007
Recruitment Status : Completed
First Posted : October 14, 2009
Results First Posted : March 29, 2016
Last Update Posted : March 29, 2016
Sponsor:
Information provided by (Responsible Party):
Katherine E. Warren, M.D., National Institutes of Health Clinical Center (CC)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glioblastoma Multiforme
Gliosarcoma
Anaplastic Astrocytoma
Anaplastic Oligodendroglioma
Anaplastic Mixed Oligoastrocytoma
Interventions Drug: ZD6474 (Vandetanib)
Drug: Carboplatin
Enrollment 112
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Carboplatin Vandetanib With Carboplatin
Hide Arm/Group Description Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

Period Title: Overall Study
Started 56 56
Crossover to Vandetanib 42 0
Completed 39 54
Not Completed 17 2
Reason Not Completed
Withdrew consent             1             0
Refused further treatment             8             2
Toxicity             8             0
Arm/Group Title Carboplatin Vandetanib With Carboplatin Total
Hide Arm/Group Description Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

Total of all reporting groups
Overall Number of Baseline Participants 56 56 112
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
53
  94.6%
52
  92.9%
105
  93.8%
>=65 years
3
   5.4%
4
   7.1%
7
   6.3%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 56 participants 56 participants 112 participants
50.29  (13.29) 50.10  (12.43) 50.13  (12.81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
Female
19
  33.9%
15
  26.8%
34
  30.4%
Male
37
  66.1%
41
  73.2%
78
  69.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
55
  98.2%
56
 100.0%
111
  99.1%
Unknown or Not Reported
1
   1.8%
0
   0.0%
1
   0.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 56 participants 56 participants 112 participants
American Indian or Alaska Native
0
   0.0%
1
   1.8%
1
   0.9%
Asian
0
   0.0%
1
   1.8%
1
   0.9%
Native Hawaiian or Other Pacific Islander
1
   1.8%
0
   0.0%
1
   0.9%
Black or African American
1
   1.8%
2
   3.6%
3
   2.7%
White
53
  94.6%
52
  92.9%
105
  93.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   1.8%
0
   0.0%
1
   0.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 56 participants 56 participants 112 participants
56 56 112
1.Primary Outcome
Title Progression Free Survival at 6 Months
Hide Description Percentage of participants who are alive and progression-free at 6 months.
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The group data is displayed per the report provided to the Food and Drug Administration.
Arm/Group Title Glioblastoma (Combination) Glioblastoma (Carboplatin Alone) Anaplastic Astrocytomas (Combination) Anaplastic Astrocytomas (Carboplatin Alone)
Hide Arm/Group Description:

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
Overall Number of Participants Analyzed 33 33 23 23
Measure Type: Number
Unit of Measure: percentage of participants
1.71 0.89 8.7 17.4
2.Secondary Outcome
Title Overall Survival
Hide Description Time between the first day of treatment and the day of death.
Time Frame Time between the first day of treatment and the day of death, up to 1.5 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The group data is displayed per the report provided to the Food and Drug Administration.
Arm/Group Title Glioblastoma (Combination) Glioblastoma (Carboplation Alone) Anaplastic Astrocytoma (Combination) Anaplastic Astrocytoma (Carboplatin Alone)
Hide Arm/Group Description:

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.
Overall Number of Participants Analyzed 33 33 23 23
Median (95% Confidence Interval)
Unit of Measure: Months
5.58
(4.60 to 8.65)
5.22
(3.78 to 7.46)
6.5
(5.42 to 11.7)
9.27
(5.52 to 43.86)
3.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description Here is the number of participants with adverse events. For a detailed list of adverse events, see the adverse event module.
Time Frame 70 months and 19 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Carboplatin Vandetanib With Carboplatin Cross Over to Vandetanib
Hide Arm/Group Description:

Combo Group (both drugs together)

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

Sequential Group (carboplatin followed by vandetanib)

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

Overall Number of Participants Analyzed 56 56 42
Measure Type: Number
Unit of Measure: participants
55 56 40
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Carboplatin Vandetanib With Carboplatin Crossover to Vandetanib
Hide Arm/Group Description Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.

Carboplatin: Carboplatin is a drug that interrupts division of cancer cells and has been shown to be a useful drug in treatment of tumors known as gliomas. It is a useful drug for treating brain tumors, but researchers are interested in gathering more information about how it works as a treatment for patients who have not responded to initial surgery, radiation, or chemotherapy.

ZD6474 (Vandetanib): Vandetanib is an oral medication known to block angiogenesis and has shown significant antitumor activity in laboratory and animal studies. Vandetanib appears to be well tolerated by patients at specific daily doses.
All-Cause Mortality
Carboplatin Vandetanib With Carboplatin Crossover to Vandetanib
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Carboplatin Vandetanib With Carboplatin Crossover to Vandetanib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   10/56 (17.86%)      21/56 (37.50%)      13/42 (30.95%)    
Cardiac disorders       
Sinus tachycardia  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal disorders       
Colonic perforation  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Nausea  1  0/56 (0.00%)  0 2/56 (3.57%)  2 0/42 (0.00%)  0
General disorders       
Death Not otherwise specified (NOS)  1  1/56 (1.79%)  1 2/56 (3.57%)  2 6/42 (14.29%)  6
Fever  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  1  0/56 (0.00%)  0 1/56 (1.79%)  1 1/42 (2.38%)  1
Infections and infestations       
Periorbital infection  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Infections and infestations - Other, specify (UTI)  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations - Other, specify (cellulitis)  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Lung infection  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Investigations       
Platelet count decreased  1  2/56 (3.57%)  3 2/56 (3.57%)  3 0/42 (0.00%)  0
Metabolism and nutrition disorders       
Dehydration  1  1/56 (1.79%)  1 0/56 (0.00%)  0 1/42 (2.38%)  1
Musculoskeletal and connective tissue disorders       
Muscle weakness right-sided  1  0/56 (0.00%)  0 1/56 (1.79%)  1 1/42 (2.38%)  1
Chest wall pain  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Nervous system disorders       
Depressed level of consciousness  1  1/56 (1.79%)  4 0/56 (0.00%)  0 0/42 (0.00%)  0
Hydrocephalus  1  1/56 (1.79%)  1 1/56 (1.79%)  1 0/42 (0.00%)  0
Intracranial hemorrhage  1  2/56 (3.57%)  2 1/56 (1.79%)  3 2/42 (4.76%)  2
Pyramidal tract syndrome  1  2/56 (3.57%)  2 0/56 (0.00%)  0 0/42 (0.00%)  0
Ataxia  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Headache  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Seizure  1  0/56 (0.00%)  0 4/56 (7.14%)  4 5/42 (11.90%)  5
Renal and urinary disorders       
Acute kidney injury  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pleural effusion  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Vascular disorders       
Thromboembolic event  1  1/56 (1.79%)  1 3/56 (5.36%)  3 0/42 (0.00%)  0
Hematoma  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
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 0%
Carboplatin Vandetanib With Carboplatin Crossover to Vandetanib
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   55/56 (98.21%)      56/56 (100.00%)      40/42 (95.24%)    
Blood and lymphatic system disorders       
Anemia  1  30/56 (53.57%)  67 26/56 (46.43%)  74 4/42 (9.52%)  4
Thrombotic thrombocytopenic purpura  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Hemolysis  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Cardiac disorders       
Cardiac disorders - Other, specify (Qtc prolonged)  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Electrocardiogram QT corrected interval prolonged  1  3/56 (5.36%)  5 22/56 (39.29%)  38 18/42 (42.86%)  27
Sinus bradycardia  1  3/56 (5.36%)  4 4/56 (7.14%)  4 5/42 (11.90%)  7
Conduction disorder  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Heart failure  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Ear and labyrinth disorders       
Ear pain  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Endocrine disorders       
Cushingoid  1  2/56 (3.57%)  2 0/56 (0.00%)  0 0/42 (0.00%)  0
Hypothyroidism  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Eye disorders       
Dry eye  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Eye disorders - Other, specify (diplopia)  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Eye disorders - Other, specify (Stye)  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Blurred vision  1  2/56 (3.57%)  2 0/56 (0.00%)  0 1/42 (2.38%)  1
Optic nerve disorder  1  1/56 (1.79%)  1 0/56 (0.00%)  0 1/42 (2.38%)  1
Gastrointestinal disorders       
Constipation  1  2/56 (3.57%)  3 4/56 (7.14%)  4 1/42 (2.38%)  1
Fecal incontinence  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Gastritis  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Gastrointestinal disorders - Other, specify (cholelithiasis)  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Rectal hemorrhage  1  1/56 (1.79%)  1 0/56 (0.00%)  0 1/42 (2.38%)  1
Vomiting  1  4/56 (7.14%)  4 4/56 (7.14%)  6 1/42 (2.38%)  1
Nausea  1  7/56 (12.50%)  11 9/56 (16.07%)  11 3/42 (7.14%)  4
Anal hemorrhage  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Diarrhea  1  0/56 (0.00%)  0 29/56 (51.79%)  46 0/42 (0.00%)  0
Dysphagia  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Gastroesophageal reflux disease  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Hemorrhoidal hemorrhage  1  0/56 (0.00%)  0 2/56 (3.57%)  2 0/42 (0.00%)  0
Hemorrhoids  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Lower gastrointestinal hemorrhage  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Oral dysesthesia  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Oral hemorrhage  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Oral pain  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Upper gastrointestinal hemorrhage  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
General disorders       
Fatigue  1  16/56 (28.57%)  29 19/56 (33.93%)  24 3/42 (7.14%)  3
Flu like symptoms  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Gait disturbance  1  1/56 (1.79%)  1 1/56 (1.79%)  1 0/42 (0.00%)  0
Infusion related reaction  1  2/56 (3.57%)  3 0/56 (0.00%)  0 0/42 (0.00%)  0
Lethargy  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Localized edema  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Pain  1  2/56 (3.57%)  2 2/56 (3.57%)  2 2/42 (4.76%)  2
Edema limbs  1  0/56 (0.00%)  0 2/56 (3.57%)  3 0/42 (0.00%)  0
Fever  1  0/56 (0.00%)  0 1/56 (1.79%)  2 0/42 (0.00%)  0
Irritability  1  0/56 (0.00%)  0 1/56 (1.79%)  2 0/42 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Infections and infestations       
Infections and infestations - Other, specify (sore throat)  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Rhinitis infective  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Salivary gland infection  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Skin infection  1  1/56 (1.79%)  1 3/56 (5.36%)  3 1/42 (2.38%)  1
Upper respiratory infection  1  1/56 (1.79%)  1 0/56 (0.00%)  0 3/42 (7.14%)  3
Infections and infestations - Other, specify (vaginal candidiasis)  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Infections and infestations - Other, specify  1 [1]  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Mucosal infection  1  1/56 (1.79%)  1 0/56 (0.00%)  0 1/42 (2.38%)  1
Urinary tract infection  1  0/56 (0.00%)  0 1/56 (1.79%)  1 1/42 (2.38%)  1
Breast infection  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Lung infection  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Paronychia  1  0/56 (0.00%)  0 2/56 (3.57%)  2 0/42 (0.00%)  0
Sinusitis  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Tooth infection  1  0/56 (0.00%)  0 1/56 (1.79%)  2 0/42 (0.00%)  0
Injury, poisoning and procedural complications       
Fall  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Injury, poisoning and procedural complications - Other, specify (left shoulder fracture)  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Bruising  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Fracture  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Investigations       
Activated partial thromboplastin time prolonged  1  2/56 (3.57%)  2 5/56 (8.93%)  11 1/42 (2.38%)  1
Alanine aminotransferase increased  1  19/56 (33.93%)  29 43/56 (76.79%)  74 24/42 (57.14%)  29
Alkaline phosphatase increased  1  4/56 (7.14%)  4 17/56 (30.36%)  20 6/42 (14.29%)  6
Aspartate aminotransferase increased  1  3/56 (5.36%)  3 28/56 (50.00%)  44 14/42 (33.33%)  17
Blood bilirubin increased  1  2/56 (3.57%)  2 8/56 (14.29%)  11 3/42 (7.14%)  3
Cholesterol high  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Creatinine increased  1  1/56 (1.79%)  1 20/56 (35.71%)  40 12/42 (28.57%)  13
Weight loss  1  2/56 (3.57%)  2 6/56 (10.71%)  7 2/42 (4.76%)  2
White blood cell decreased  1  33/56 (58.93%)  108 29/56 (51.79%)  96 14/42 (33.33%)  17
CPK increased  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Hemoglobin increased  1  0/56 (0.00%)  0 3/56 (5.36%)  5 4/42 (9.52%)  4
Investigations - Other, specify  1 [2]  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Lymphocyte count decreased  1  39/56 (69.64%)  122 44/56 (78.57%)  122 27/42 (64.29%)  44
Lymphocyte count increased  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Neutrophil count decreased  1  18/56 (32.14%)  59 15/56 (26.79%)  48 5/42 (11.90%)  6
Platelet count decreased  1  48/56 (85.71%)  119 51/56 (91.07%)  129 17/42 (40.48%)  21
INR increased  1  0/56 (0.00%)  0 1/56 (1.79%)  2 0/42 (0.00%)  0
Investigations - Other, specify (elevated LDH)  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Metabolism and nutrition disorders       
Acidosis  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Anorexia  1  1/56 (1.79%)  1 3/56 (5.36%)  3 4/42 (9.52%)  5
Hypercalcemia  1  1/56 (1.79%)  1 1/56 (1.79%)  1 3/42 (7.14%)  3
Hyperglycemia  1  6/56 (10.71%)  6 3/56 (5.36%)  4 5/42 (11.90%)  5
Hyperkalemia  1  0/56 (0.00%)  0 5/56 (8.93%)  7 4/42 (9.52%)  5
Hypermagnesemia  1  5/56 (8.93%)  5 9/56 (16.07%)  11 3/42 (7.14%)  3
Hypernatremia  1  3/56 (5.36%)  3 6/56 (10.71%)  15 2/42 (4.76%)  2
Hypertriglyceridemia  1  1/56 (1.79%)  1 0/56 (0.00%)  0 1/42 (2.38%)  1
Hypoalbuminemia  1  1/56 (1.79%)  1 12/56 (21.43%)  23 1/42 (2.38%)  1
Hypocalcemia  1  4/56 (7.14%)  7 15/56 (26.79%)  19 4/42 (9.52%)  5
Hypoglycemia  1  0/56 (0.00%)  0 2/56 (3.57%)  2 2/42 (4.76%)  2
Hypokalemia  1  1/56 (1.79%)  1 4/56 (7.14%)  8 3/42 (7.14%)  3
Hypomagnesemia  1  7/56 (12.50%)  9 17/56 (30.36%)  44 2/42 (4.76%)  2
Hyponatremia  1  5/56 (8.93%)  7 11/56 (19.64%)  14 5/42 (11.90%)  6
Hypophosphatemia  1  19/56 (33.93%)  25 19/56 (33.93%)  34 11/42 (26.19%)  12
Dehydration  1  1/56 (1.79%)  1 2/56 (3.57%)  2 0/42 (0.00%)  0
Metabolism and nutrition disorders - Other, specify  1 [3]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/56 (1.79%)  1 1/56 (1.79%)  1 1/42 (2.38%)  1
Back pain  1  1/56 (1.79%)  1 1/56 (1.79%)  1 1/42 (2.38%)  1
Muscle weakness left-sided  1  0/56 (0.00%)  0 4/56 (7.14%)  4 4/42 (9.52%)  4
Muscle weakness lower limb  1  2/56 (3.57%)  2 3/56 (5.36%)  3 2/42 (4.76%)  2
Muscle weakness right-sided  1  2/56 (3.57%)  2 3/56 (5.36%)  4 1/42 (2.38%)  1
Muscle weakness upper limb  1  0/56 (0.00%)  0 1/56 (1.79%)  1 1/42 (2.38%)  1
Pain in extremity  1  1/56 (1.79%)  1 3/56 (5.36%)  5 1/42 (2.38%)  1
Generalized muscle weakness  1  2/56 (3.57%)  2 4/56 (7.14%)  6 1/42 (2.38%)  1
Neck pain  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Nervous system disorders       
Cognitive disturbance  1  1/56 (1.79%)  2 0/56 (0.00%)  0 3/42 (7.14%)  3
Concentration impairment  1  1/56 (1.79%)  1 1/56 (1.79%)  1 0/42 (0.00%)  0
Confusion  1  1/56 (1.79%)  1 3/56 (5.36%)  3 2/42 (4.76%)  2
Depressed level of consciousness  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Dizziness  1  2/56 (3.57%)  2 3/56 (5.36%)  3 0/42 (0.00%)  0
Dysesthesia  1  1/56 (1.79%)  1 1/56 (1.79%)  1 0/42 (0.00%)  0
Dysphasia  1  4/56 (7.14%)  4 3/56 (5.36%)  3 2/42 (4.76%)  4
Nervous system disorders - Other, specify  1 [4]  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Nervous system disorders - Other, specify (visual field deficit)  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Oculomotor nerve disorder  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Paresthesia  1  1/56 (1.79%)  2 0/56 (0.00%)  0 0/42 (0.00%)  0
Presyncope  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Psychosis  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Pyramidal tract syndrome  1  4/56 (7.14%)  5 2/56 (3.57%)  3 1/42 (2.38%)  2
Seizure  1  7/56 (12.50%)  9 14/56 (25.00%)  33 4/42 (9.52%)  4
Syncope  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Acoustic nerve disorder Not otherwise specified (NOS)  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Ataxia  1  0/56 (0.00%)  0 3/56 (5.36%)  4 1/42 (2.38%)  1
Dysarthria  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Dysgeusia  1  0/56 (0.00%)  0 1/56 (1.79%)  1 1/42 (2.38%)  1
Hypersomnia  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Insomnia  1  0/56 (0.00%)  0 0/56 (0.00%)  0 2/42 (4.76%)  2
Memory impairment  1  1/56 (1.79%)  1 1/56 (1.79%)  1 3/42 (7.14%)  3
Nervous system disorders - Other, specify  1 [5]  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Peripheral sensory neuropathy  1  0/56 (0.00%)  0 0/56 (0.00%)  0 2/42 (4.76%)  2
Somnolence  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Tremor  1  0/56 (0.00%)  0 2/56 (3.57%)  3 1/42 (2.38%)  1
Encephalopathy  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Headache  1  8/56 (14.29%)  10 5/56 (8.93%)  6 4/42 (9.52%)  6
Hydrocephalus  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Intracranial hemorrhage  1  0/56 (0.00%)  0 4/56 (7.14%)  5 0/42 (0.00%)  0
Nervous system disorders - Other, specify  1 [6]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Psychiatric disorders       
Depression  1  2/56 (3.57%)  2 5/56 (8.93%)  6 2/42 (4.76%)  2
Agitation  1  2/56 (3.57%)  2 2/56 (3.57%)  2 2/42 (4.76%)  2
Insomnia  1  0/56 (0.00%)  0 2/56 (3.57%)  2 0/42 (0.00%)  0
Renal and urinary disorders       
Urinary incontinence  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Acute kidney injury  1  0/56 (0.00%)  0 2/56 (3.57%)  4 1/42 (2.38%)  1
Renal colic  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Urinary urgency  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Hematuria  1  0/56 (0.00%)  0 2/56 (3.57%)  3 0/42 (0.00%)  0
Hemoglobinuria  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Proteinuria  1  1/56 (1.79%)  1 5/56 (8.93%)  8 1/42 (2.38%)  1
Urinary frequency  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Reproductive system and breast disorders       
Erectile dysfunction  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  1/56 (1.79%)  1 0/56 (0.00%)  0 1/42 (2.38%)  1
Dyspnea  1  1/56 (1.79%)  1 1/56 (1.79%)  1 0/42 (0.00%)  0
Epistaxis  1  2/56 (3.57%)  2 4/56 (7.14%)  5 1/42 (2.38%)  1
Laryngeal inflammation  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  1 [7]  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Wheezing  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Hypoxia  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Voice alteration  1  0/56 (0.00%)  0 1/56 (1.79%)  1 1/42 (2.38%)  1
Allergic rhinitis  1  0/56 (0.00%)  0 2/56 (3.57%)  2 0/42 (0.00%)  0
Hoarseness  1  2/56 (3.57%)  3 3/56 (5.36%)  3 3/42 (7.14%)  3
Nasal congestion  1  1/56 (1.79%)  1 1/56 (1.79%)  1 0/42 (0.00%)  0
Pleural effusion  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Postnasal drip  1  0/56 (0.00%)  0 1/56 (1.79%)  2 0/42 (0.00%)  0
Respiratory, thoracic and mediastinal disorders - Other, specify  1 [8]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash acneiform  1  2/56 (3.57%)  2 35/56 (62.50%)  45 24/42 (57.14%)  27
Erythema multiforme  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Hyperhidrosis  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Palmar-plantar erythrodysesthesia syndrome  1  0/56 (0.00%)  0 2/56 (3.57%)  4 1/42 (2.38%)  1
Photosensitivity  1  0/56 (0.00%)  0 7/56 (12.50%)  10 6/42 (14.29%)  6
Pruritus  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  2
Skin and subcutaneous tissue disorders - Other, specify (erythema)  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Skin ulceration  1  2/56 (3.57%)  2 0/56 (0.00%)  0 1/42 (2.38%)  1
Rash maculo-papular  1  0/56 (0.00%)  0 3/56 (5.36%)  3 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1 [9]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1 [10]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1 [11]  0/56 (0.00%)  0 1/56 (1.79%)  2 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1 [12]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1 [13]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1 [14]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1 [15]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify (paronychia)  1  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Skin and subcutaneous tissue disorders - Other, specify  1 [16]  0/56 (0.00%)  0 1/56 (1.79%)  1 0/42 (0.00%)  0
Vascular disorders       
Hot flashes  1  1/56 (1.79%)  1 0/56 (0.00%)  0 0/42 (0.00%)  0
Superficial thrombophlebitis  1  1/56 (1.79%)  2 0/56 (0.00%)  0 0/42 (0.00%)  0
Flushing  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Lymphedema  1  0/56 (0.00%)  0 0/56 (0.00%)  0 1/42 (2.38%)  1
Thromboembolic event  1  0/56 (0.00%)  0 2/56 (3.57%)  2 1/42 (2.38%)  1
Hypertension  1  0/56 (0.00%)  0 23/56 (41.07%)  35 12/42 (28.57%)  14
Hypotension  1  1/56 (1.79%)  1 1/56 (1.79%)  1 0/42 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Had UTI with pseudomonas
[2]
Azotemia/Urea nitrogen (BUN)
[3]
elevated bilirubin
[4]
aphasia and right upper extremity weakness
[5]
left side Hemineglect
[6]
subdural hygroma
[7]
lung infection
[8]
nasal septum erosions
[9]
Bug bites
[10]
Morphea vs. psoriasiform plaque-left arm
[11]
Sebaceous cyst
[12]
Seborrheic dermatitis vs. inverse psoriasis-buttocks
[13]
skin laceration
[14]
Inflammation around nail bed
[15]
Navel area irritation
[16]
2 reddened areas
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Katherine E. Warren
Organization: National Cancer Institute
Phone: 301-435-4683
Publications of Results:
A randomized phase II trial of Vandetanib (ZD6474) in combination with carboplatin versus carboplatin alone in adults with recurrent glioblastoma. Katherine McNeill, Fabio Iwamoto, Teri Kreisl, Joohee Sul, Joanna Shih, Howard Fine, New York University, New York, NY, USA, Columbia University, New York, NY, USA, National Institutes of Health, Bethesda, MD, USA, Food and Drug Administration, Silver Spring, MD, USA.
A randomized phase II trial of Vandetanib in combination with carboplatin versus carboplatin alone followed by Vandetanib aline in adults with recurrent anaplastic astrocytoma. Prakash Ambady, Katherine Warren, Joanna Shih, Teri Kreisl, Howard Fine, National Institutes of Health, Bethesda, MD, USA.
Responsible Party: Katherine E. Warren, M.D., National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier: NCT00995007     History of Changes
Other Study ID Numbers: 090222
09-C-0222
First Submitted: October 10, 2009
First Posted: October 14, 2009
Results First Submitted: December 9, 2015
Results First Posted: March 29, 2016
Last Update Posted: March 29, 2016