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Everolimus and Gefitinib in Treating Patients With Progressive Glioblastoma Multiforme or Progressive Metastatic Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00085566
Recruitment Status : Completed
First Posted : June 11, 2004
Results First Posted : January 20, 2016
Last Update Posted : January 20, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Brain and Central Nervous System Tumors
Prostate Cancer
Interventions Drug: everolimus
Drug: gefitinib
Enrollment 61
Recruitment Details  
Pre-assignment Details  
Arm/Group Title RAD 001 30 mg RAD 001 50 mg RAD 001 70 mg
Hide Arm/Group Description 30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer 50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer 70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
Period Title: Overall Study
Started 3 3 57
Completed 3 3 43
Not Completed 0 0 14
Reason Not Completed
Adverse Event             0             0             10
Patient Not treated             0             0             3
Clinical progression             0             0             1
Arm/Group Title RAD 001 30 mg RAD 001 50 mg RAD 001 70 mg Total
Hide Arm/Group Description 30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer 50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer 70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer Total of all reporting groups
Overall Number of Baseline Participants 3 3 57 63
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 57 participants 63 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
1
  33.3%
1
  33.3%
32
  56.1%
34
  54.0%
>=65 years
2
  66.7%
2
  66.7%
25
  43.9%
29
  46.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 3 participants 57 participants 63 participants
Female
0
   0.0%
0
   0.0%
11
  19.3%
11
  17.5%
Male
3
 100.0%
3
 100.0%
46
  80.7%
52
  82.5%
1.Primary Outcome
Title Overall Objective Response
Hide Description Response will be evaluated in this study using the new international criteria Response Evaluation Criteria in Solid Tumors (RECIST)
Time Frame 2 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title RAD 001 30 mg RAD 001 50 mg RAD 001 70 mg
Hide Arm/Group Description:
30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
Overall Number of Participants Analyzed 3 3 43
Measure Type: Number
Unit of Measure: participants
Partial Response (PR) 0 0 2
Stable Disease (SD) 0 1 15
Progression of Disease (POD) 3 2 26
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title RAD 001 30 mg RAD 001 50 mg RAD 001 70 mg
Hide Arm/Group Description 30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer 50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer 70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
All-Cause Mortality
RAD 001 30 mg RAD 001 50 mg RAD 001 70 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
RAD 001 30 mg RAD 001 50 mg RAD 001 70 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/3 (0.00%)      1/3 (33.33%)      18/57 (31.58%)    
Blood and lymphatic system disorders       
Hemoglobin  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/57 (0.00%)  0
ALT, SGPT  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Hemorrhage, Peritoneal cavity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Leukocytes (total WBC)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Cardiac disorders       
Cardiac General, other  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Eye disorders       
Vision-blurred vision  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/57 (0.00%)  0
Gastrointestinal disorders       
Diarrhea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Nausea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
General disorders       
Death not associated w CTCAE term-Disease progression NOS  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Dehydration  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Extremity-lower (gait/walking)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Fatigue (asthenia, lethargy, malaise)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Muscle weakness - Extremity-lower  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Pain - Head/headache  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/57 (3.51%)  2
Infections and infestations       
Infection, other  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Metabolism and nutrition disorders       
Creatinine  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Nervous system disorders       
Confusion  1  0/3 (0.00%)  0 1/3 (33.33%)  1 2/57 (3.51%)  2
Hydrocephalus  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/57 (0.00%)  0
Mood alteration - Agitation  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Neurology - Other  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Seizure  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/57 (5.26%)  3
Renal and urinary disorders       
Incontinence, urinary  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Renal failure  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/57 (3.51%)  2
Urinary retention (including neurogenic bladder)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Respiratory, thoracic and mediastinal disorders       
Dyspnea (shortness of breath)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Pulmonary/upper respiratory - Other  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Thrombosis/embolism (vascular access-related)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Thrombosis/thrombus/embolism  1  0/3 (0.00%)  0 0/3 (0.00%)  0 2/57 (3.51%)  2
Skin and subcutaneous tissue disorders       
Skin infection  1  0/3 (0.00%)  0 0/3 (0.00%)  0 1/57 (1.75%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
RAD 001 30 mg RAD 001 50 mg RAD 001 70 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/3 (66.67%)      3/3 (100.00%)      48/57 (84.21%)    
Blood and lymphatic system disorders       
Hemoglobin  1  1/3 (33.33%)  1 2/3 (66.67%)  2 20/57 (35.09%)  20
Prothrombin Time and International Normalized Ratio  1  0/3 (0.00%)  0 0/3 (0.00%)  0 5/57 (8.77%)  5
Leukocytes (total WBC)  1  0/3 (0.00%)  0 1/3 (33.33%)  1 10/57 (17.54%)  10
Lymphopenia  1  0/3 (0.00%)  0 1/3 (33.33%)  1 17/57 (29.82%)  17
Neutrophils/granulocytes (ANC/AGC)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 5/57 (8.77%)  5
Platelets  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/57 (7.02%)  4
Partial Thromboplastin Time (PTT)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 6/57 (10.53%)  6
Gastrointestinal disorders       
Nausea  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/57 (5.26%)  3
General disorders       
Edema: limb  1  0/3 (0.00%)  0 0/3 (0.00%)  0 5/57 (8.77%)  5
Fatigue (asthenia, lethargy, malaise)  1  1/3 (33.33%)  1 1/3 (33.33%)  1 12/57 (21.05%)  12
Mucositis (Clincal exam)- Oral cavity  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/57 (7.02%)  4
Pain - Bone  1  1/3 (33.33%)  1 0/3 (0.00%)  0 0/57 (0.00%)  0
Extremity-lower (gait/walking)  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/57 (0.00%)  0
Metabolism and nutrition disorders       
Albumin, low (hypoalbuminemia)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/57 (7.02%)  4
Alkaline phosphatase  1  2/3 (66.67%)  2 0/3 (0.00%)  0 8/57 (14.04%)  8
ALT, SGPT  1  0/3 (0.00%)  0 0/3 (0.00%)  0 8/57 (14.04%)  8
AST, SGOT  1  1/3 (33.33%)  1 0/3 (0.00%)  0 6/57 (10.53%)  6
Calcium, low (hypocalcemia)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 10/57 (17.54%)  10
Cholesterol, high (hypercholestremia)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 3/57 (5.26%)  3
Creatinine  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/57 (7.02%)  4
Glucose, high (hyperglycemia)  1  0/3 (0.00%)  0 2/3 (66.67%)  2 19/57 (33.33%)  19
Phosphate, low (hypophosphatemia)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 6/57 (10.53%)  6
Sodium, low (hyponatremia)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 4/57 (7.02%)  4
Nervous system disorders       
Seizure  1  0/3 (0.00%)  0 0/3 (0.00%)  0 6/57 (10.53%)  6
Neuropathy: sensory  1  1/3 (33.33%)  1 1/3 (33.33%)  1 0/57 (0.00%)  0
Reproductive system and breast disorders       
Dyspnea (shortness of breath)  1  0/3 (0.00%)  0 0/3 (0.00%)  0 8/57 (14.04%)  8
Skin and subcutaneous tissue disorders       
Rash: acne/acneiform  1  0/3 (0.00%)  0 0/3 (0.00%)  0 6/57 (10.53%)  6
Pruritus/itching  1  0/3 (0.00%)  0 1/3 (33.33%)  1 0/57 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTC-3.0
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Howard Scher
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-422-4323
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00085566     History of Changes
Other Study ID Numbers: 04-010
MSKCC-04010
First Submitted: June 10, 2004
First Posted: June 11, 2004
Results First Submitted: December 15, 2015
Results First Posted: January 20, 2016
Last Update Posted: January 20, 2016