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Sorafenib With or Without Paclitaxel and Carboplatin in Treating Patients With Recurrent Ovarian Cancer, Primary Peritoneal Cancer, or Fallopian Tube Cancer

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ClinicalTrials.gov Identifier: NCT00096200
Recruitment Status : Completed
First Posted : November 9, 2004
Results First Posted : December 13, 2012
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Recurrent Fallopian Tube Carcinoma
Recurrent Ovarian Carcinoma
Recurrent Primary Peritoneal Carcinoma
Interventions Drug: Carboplatin
Drug: Paclitaxel
Drug: Sorafenib Tosylate
Enrollment 44
Recruitment Details Patients accrued from medical clinic from August 2004 through June 2011
Pre-assignment Details  
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients from Arm A that had progressive disease were eligible to crossover to Arm B
Period Title: Overall Study
Started 9 30 5
Completed 8 23 5
Not Completed 1 7 0
Reason Not Completed
Adverse Event             0             4             0
Withdrawal by Subject             1             2             0
Ineligible pathology             0             1             0
Arm/Group Title Arm A Arm B Arm C Total
Hide Arm/Group Description Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients from Arm A that had progressive disease were eligible to crossover to Arm B Total of all reporting groups
Overall Number of Baseline Participants 9 30 5 44
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants 30 participants 5 participants 44 participants
Age 40-49 0 2 0 2
Age 50-59 4 15 0 19
Age 60-69 4 8 5 17
Age 70-79 1 5 0 6
[1]
Measure Description: Age in years
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 30 participants 5 participants 44 participants
Female
9
 100.0%
30
 100.0%
5
 100.0%
44
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 30 participants 5 participants 44 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
8
  88.9%
22
  73.3%
5
 100.0%
35
  79.5%
Unknown or Not Reported
1
  11.1%
8
  26.7%
0
   0.0%
9
  20.5%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants 30 participants 5 participants 44 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
9
 100.0%
24
  80.0%
5
 100.0%
38
  86.4%
More than one race
0
   0.0%
1
   3.3%
0
   0.0%
1
   2.3%
Unknown or Not Reported
0
   0.0%
5
  16.7%
0
   0.0%
5
  11.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 9 participants 30 participants 5 participants 44 participants
9 30 5 44
1.Primary Outcome
Title Complete and Partial Response Rate Using the Response Evaluation Criteria in Solid Tumors (RECIST) Criteria
Hide Description Patients should be reevaluated for response every 2 cycles (6 weeks). Patients who continue on Arm A of treatment for more than 12 months should be reevaluated for response every 3 cycles (9 weeks). In addition to a baseline scan, confirmatory scans should also be obtained 4 weeks following initial documentation of objective response.
Time Frame after 6 weeks (2 cycles)
Hide Outcome Measure Data
Hide Analysis Population Description
Patients that received 2 cycles of treatment. Includes results from patients that crossed over to Arm C.
Arm/Group Title Arm A Arm B Arm C: Crossover From Arm A to B
Hide Arm/Group Description:
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.
Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13 23 5
Measure Type: Number
Unit of Measure: participants
Partial Response 2 11 1
Progressive Disease 8 1 0
Stable Disease 3 7 4
Complete Response 0 4 0
2.Secondary Outcome
Title Evaluate the Progression-free Survival Rate
Hide Description Progression free survival (PFS) was measured by months from the date of treatment to the date of death or the date of progression, and censored at the date of last follow-up for those alive without progression.
Time Frame up to 85 months of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects who completed at least 2 cycles of therapy
Arm/Group Title Arm A Arm B Arm C: Crossover From Arm A to B
Hide Arm/Group Description:
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.
Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13 23 5
Median (95% Confidence Interval)
Unit of Measure: months
5.6
(3.4 to 17.6)
16.8
(12.6 to 20.4)
16.8
(12.6 to 20.4)
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival time, in months, is calculated from the date of treatment to date of death, and to date of last follow-up for those still alive.
Time Frame up to 85 months of follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects that received at least 2 cycles of treatment
Arm/Group Title Arm A Arm B Arm C: Crossover From Arm A to B
Hide Arm/Group Description:
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.
Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Overall Number of Participants Analyzed 13 23 5
Median (95% Confidence Interval)
Unit of Measure: months
25.6
(16.2 to 68.3)
25.9
(15.4 to 42.1)
25.9
(15.4 to 42.1)
Time Frame Adverse events collected during treatment for all patients over a 7 year period from 2004-2011.
Adverse Event Reporting Description Serious Adverse Event and Adverse Event data reported on Arm A includes events from Arm C patients while on Arm A.
 
Arm/Group Title Arm A Arm B Arm C
Hide Arm/Group Description Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients from Arm A that had progressive disease were eligible to crossover to Arm B
All-Cause Mortality
Arm A Arm B Arm C
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A Arm B Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/14 (21.43%)      5/30 (16.67%)      2/5 (40.00%)    
Blood and lymphatic system disorders       
Febrile neutropenia  1  0/14 (0.00%)  0 2/30 (6.67%)  2 0/5 (0.00%)  0
Thrombocytopenia  1  0/14 (0.00%)  0 1/30 (3.33%)  1 0/5 (0.00%)  0
Gastrointestinal disorders       
Bowel obstruction  1  0/14 (0.00%)  0 0/30 (0.00%)  0 1/5 (20.00%)  1
Diarrhea  1  1/14 (7.14%)  1 0/30 (0.00%)  0 0/5 (0.00%)  0
Nausea  1  1/14 (7.14%)  1 0/30 (0.00%)  0 0/5 (0.00%)  0
Vomiting  1  0/14 (0.00%)  0 0/30 (0.00%)  0 1/5 (20.00%)  1
General disorders       
Fever (in the absence of neutropenia, where neutropenia is defined as AGC<1.0 x 10e9/L)  1  1/14 (7.14%)  1 1/30 (3.33%)  1 0/5 (0.00%)  0
Immune system disorders       
Allergic reaction/hypersensitivity (including drug fever)  1  0/14 (0.00%)  0 1/30 (3.33%)  1 1/5 (20.00%)  1
Injury, poisoning and procedural complications       
Fracture/Right Shoulder  1 [1]  0/14 (0.00%)  0 1/30 (3.33%)  1 0/5 (0.00%)  0
Investigations       
White blood cell decreased/Neutropenia  1  0/14 (0.00%)  0 2/30 (6.67%)  2 0/5 (0.00%)  0
Metabolism and nutrition disorders       
Hypokalemia  1  1/14 (7.14%)  1 0/30 (0.00%)  0 0/5 (0.00%)  0
Hyponatremia  1  1/14 (7.14%)  1 0/30 (0.00%)  0 0/5 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Secondary Malignancy-Other, excludes metastasis from initial primary  1  2/14 (14.29%)  2 0/30 (0.00%)  0 0/5 (0.00%)  0
Nervous system disorders       
Pain- Headache  1  1/14 (7.14%)  1 0/30 (0.00%)  0 0/5 (0.00%)  0
Syncope  1  0/14 (0.00%)  0 1/30 (3.33%)  1 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Pleural effusion (non-malignant)  1  1/14 (7.14%)  1 0/30 (0.00%)  0 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders       
Keratosis on left lateral forearm  1  1/14 (7.14%)  1 0/30 (0.00%)  0 0/5 (0.00%)  0
Rash/desquamation  1  1/14 (7.14%)  1 1/30 (3.33%)  1 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Unrelated to treatment. Patient tripped and fell.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Arm A Arm B Arm C
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   13/13 (100.00%)      29/29 (100.00%)      5/5 (100.00%)    
Blood and lymphatic system disorders       
Anemia  1  3/13 (23.08%)  4 5/29 (17.24%)  13 2/5 (40.00%)  9
Febrile neutropenia  1  0/13 (0.00%)  0 2/29 (6.90%)  2 0/5 (0.00%)  0
Cardiac disorders       
Palpitations  1  1/13 (7.69%)  1 1/29 (3.45%)  1 0/5 (0.00%)  0
Eye disorders       
Dry Eyes  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Keratitis  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Gastrointestinal disorders       
Abdominal Bloating  1  2/13 (15.38%)  2 1/29 (3.45%)  1 0/5 (0.00%)  0
Abdominal pain  1  4/13 (30.77%)  5 7/29 (24.14%)  9 0/5 (0.00%)  0
Anal Pain  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Anal hemorrhage  1  1/13 (7.69%)  1 2/29 (6.90%)  6 0/5 (0.00%)  0
Bleeding gums  1  0/13 (0.00%)  0 1/29 (3.45%)  6 1/5 (20.00%)  1
Constipation  1  4/13 (30.77%)  4 8/29 (27.59%)  11 1/5 (20.00%)  1
Diarrhea  1  8/13 (61.54%)  16 13/29 (44.83%)  16 4/5 (80.00%)  8
Dry Mouth  1  2/13 (15.38%)  2 0/29 (0.00%)  0 0/5 (0.00%)  0
Dyspepsia  1  1/13 (7.69%)  1 7/29 (24.14%)  8 0/5 (0.00%)  0
Dysphagia  1  0/13 (0.00%)  0 2/29 (6.90%)  2 0/5 (0.00%)  0
Flatulence  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Lip Pain  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Mouth Pain  1  0/13 (0.00%)  0 2/29 (6.90%)  3 0/5 (0.00%)  0
Mucositis oral  1  2/13 (15.38%)  2 6/29 (20.69%)  9 0/5 (0.00%)  0
Nausea  1  4/13 (30.77%)  6 14/29 (48.28%)  19 2/5 (40.00%)  4
Stomach Pain  1  3/13 (23.08%)  3 0/29 (0.00%)  0 0/5 (0.00%)  0
Vomiting  1  0/13 (0.00%)  0 8/29 (27.59%)  16 0/5 (0.00%)  0
General disorders       
Back Pain  1  3/13 (23.08%)  3 4/29 (13.79%)  4 0/5 (0.00%)  0
Edema Limbs  1  0/13 (0.00%)  0 2/29 (6.90%)  4 1/5 (20.00%)  1
Fatigue  1  8/13 (61.54%)  20 18/29 (62.07%)  38 3/5 (60.00%)  5
Fever  1  2/13 (15.38%)  2 2/29 (6.90%)  3 1/5 (20.00%)  2
Infusion Site Extravasation  1  0/13 (0.00%)  0 0/29 (0.00%)  0 1/5 (20.00%)  1
Non-Cardiac Chest Pain  1  1/13 (7.69%)  1 0/29 (0.00%)  0 1/5 (20.00%)  1
Pain  1  1/13 (7.69%)  2 0/29 (0.00%)  0 2/5 (40.00%)  2
Immune system disorders       
Allergic reaction/hypersensitivity to carboplatin  1  1/13 (7.69%)  1 3/29 (10.34%)  3 0/5 (0.00%)  0
Anaphylaxis  1  0/13 (0.00%)  0 3/29 (10.34%)  3 0/5 (0.00%)  0
Infections and infestations       
Bronchial Infection  1  1/13 (7.69%)  1 1/29 (3.45%)  1 0/5 (0.00%)  0
Mucosal Infection/Thrush  1  0/13 (0.00%)  0 3/29 (10.34%)  3 0/5 (0.00%)  0
Rash Pustular  1  1/13 (7.69%)  1 0/29 (0.00%)  0 1/5 (20.00%)  1
Sinusitis  1  1/13 (7.69%)  1 1/29 (3.45%)  1 0/5 (0.00%)  0
Upper respiratory infection  1  2/13 (15.38%)  2 2/29 (6.90%)  2 0/5 (0.00%)  0
Urinary tract infection  1  2/13 (15.38%)  4 4/29 (13.79%)  4 1/5 (20.00%)  1
Investigations       
Alanine aminotransferase increased  1  1/13 (7.69%)  3 1/29 (3.45%)  1 0/5 (0.00%)  0
Alkaline Phosphatase Increase  1  2/13 (15.38%)  2 0/29 (0.00%)  0 0/5 (0.00%)  0
Blood Bilirubin Increased  1  1/13 (7.69%)  4 0/29 (0.00%)  0 0/5 (0.00%)  0
Lymphopenia  1  0/13 (0.00%)  0 4/29 (13.79%)  27 0/5 (0.00%)  0
Neutrophil count decreased  1  2/13 (15.38%)  7 22/29 (75.86%)  78 3/5 (60.00%)  15
Platelet count decreased  1  1/13 (7.69%)  10 19/29 (65.52%)  65 3/5 (60.00%)  13
Weight Loss  1  3/13 (23.08%)  3 2/29 (6.90%)  3 0/5 (0.00%)  0
White blood cell decreased  1  2/13 (15.38%)  22 15/29 (51.72%)  71 3/5 (60.00%)  6
Metabolism and nutrition disorders       
Anorexia  1  3/13 (23.08%)  3 7/29 (24.14%)  13 0/5 (0.00%)  0
Dehydration  1  1/13 (7.69%)  1 1/29 (3.45%)  1 0/5 (0.00%)  0
Hyperglycemia  1  2/13 (15.38%)  8 4/29 (13.79%)  7 0/5 (0.00%)  0
Hyperkalemia  1  1/13 (7.69%)  1 5/29 (17.24%)  5 0/5 (0.00%)  0
Hypoalbuminemia  1  0/13 (0.00%)  0 2/29 (6.90%)  2 0/5 (0.00%)  0
Hypocalcemia  1  0/13 (0.00%)  0 2/29 (6.90%)  3 1/5 (20.00%)  1
Hypokalemia  1  2/13 (15.38%)  8 5/29 (17.24%)  15 2/5 (40.00%)  2
Hypomagnesemia  1  2/13 (15.38%)  4 1/29 (3.45%)  1 1/5 (20.00%)  1
Hyponatremia  1  1/13 (7.69%)  1 4/29 (13.79%)  10 1/5 (20.00%)  1
Hypophosphatemia  1  2/13 (15.38%)  3 4/29 (13.79%)  5 1/5 (20.00%)  2
Musculoskeletal and connective tissue disorders       
Arthralgia (joint pain)  1  2/13 (15.38%)  2 5/29 (17.24%)  7 0/5 (0.00%)  0
Arthritis  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Bone pain  1  0/13 (0.00%)  0 3/29 (10.34%)  3 0/5 (0.00%)  0
Myalgia  1  3/13 (23.08%)  3 10/29 (34.48%)  16 0/5 (0.00%)  0
Pain in Extremity  1  5/13 (38.46%)  12 5/29 (17.24%)  7 2/5 (40.00%)  2
Nervous system disorders       
Dizziness  1  1/13 (7.69%)  1 4/29 (13.79%)  5 0/5 (0.00%)  0
Headache  1  4/13 (30.77%)  4 6/29 (20.69%)  9 0/5 (0.00%)  0
Peripheral sensory neuropathy  1  2/13 (15.38%)  2 19/29 (65.52%)  29 3/5 (60.00%)  8
Psychiatric disorders       
Anxiety  1  0/13 (0.00%)  0 2/29 (6.90%)  2 0/5 (0.00%)  0
Insomnia  1  0/13 (0.00%)  0 2/29 (6.90%)  2 0/5 (0.00%)  0
Renal and urinary disorders       
New right hydroureter  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Urinary Tract Pain  1  0/13 (0.00%)  0 2/29 (6.90%)  2 0/5 (0.00%)  0
Reproductive system and breast disorders       
Breast Pain  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Vaginal Pain  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Vaginal discharge/Yeast Infection  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Allergic Rhinitis  1  1/13 (7.69%)  1 1/29 (3.45%)  1 1/5 (20.00%)  1
Cough  1  0/13 (0.00%)  0 2/29 (6.90%)  2 0/5 (0.00%)  0
Dyspnea (shortness of breath)  1  0/13 (0.00%)  0 2/29 (6.90%)  2 1/5 (20.00%)  1
Epistaxis  1  0/13 (0.00%)  0 3/29 (10.34%)  3 2/5 (40.00%)  2
Laryngeal inflammation  1 [1]  0/13 (0.00%)  0 2/29 (6.90%)  2 0/5 (0.00%)  0
Postnasal Drip  1  0/13 (0.00%)  0 0/29 (0.00%)  0 1/5 (20.00%)  2
Voice Changes/Hoarseness  1  0/13 (0.00%)  0 3/29 (10.34%)  3 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders       
Alopecia  1  6/13 (46.15%)  8 13/29 (44.83%)  16 2/5 (40.00%)  2
Dry skin  1  4/13 (30.77%)  4 4/29 (13.79%)  4 0/5 (0.00%)  0
Nail Discoloration  1  1/13 (7.69%)  1 1/29 (3.45%)  1 0/5 (0.00%)  0
Palmar-plantar erythrodysesthesia syndrome  1  7/13 (53.85%)  14 22/29 (75.86%)  48 0/5 (0.00%)  0
Pruritus  1  4/13 (30.77%)  4 6/29 (20.69%)  10 1/5 (20.00%)  2
Rash acneiform  1  10/13 (76.92%)  22 13/29 (44.83%)  25 1/5 (20.00%)  1
Rash maculo-papular  1  1/13 (7.69%)  1 5/29 (17.24%)  7 1/5 (20.00%)  2
Scalp Pain  1  2/13 (15.38%)  2 0/29 (0.00%)  0 0/5 (0.00%)  0
Skin Hyperpigmentation  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Skin Hypopigmentation  1  1/13 (7.69%)  1 0/29 (0.00%)  0 0/5 (0.00%)  0
Skin Ulceration  1 [2]  0/13 (0.00%)  0 0/29 (0.00%)  0 1/5 (20.00%)  1
Vascular disorders       
Flushing  1  2/13 (15.38%)  5 1/29 (3.45%)  1 0/5 (0.00%)  0
Hypertension  1  6/13 (46.15%)  9 12/29 (41.38%)  19 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
[1]
Sore throat
[2]
Karakanthoma on right foot
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Steven Waggoner, MD
Organization: University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Phone: 216-844-5011
EMail: steven.waggoner@uhhospitals.org
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00096200     History of Changes
Other Study ID Numbers: NCI-2009-00067
NCI-2009-00067 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE 2804
CDR0000390331
CASE 2804 ( Other Identifier: Case Comprehensive Cancer Center )
6557 ( Other Identifier: CTEP )
N01CM62208 ( U.S. NIH Grant/Contract )
P30CA043703 ( U.S. NIH Grant/Contract )
U01CA062502 ( U.S. NIH Grant/Contract )
First Submitted: November 9, 2004
First Posted: November 9, 2004
Results First Submitted: November 8, 2012
Results First Posted: December 13, 2012
Last Update Posted: September 14, 2018