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CCI-779 and Rituximab in Treating Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00109967
First Posted: May 4, 2005
Last Update Posted: April 17, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
National Cancer Institute (NCI)
Results First Submitted: December 3, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Recurrent Mantle Cell Lymphoma
Interventions: Biological: rituximab
Drug: temsirolimus

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Seventy-one patients seen at 35 sites were enrolled on this trial between May 6, 2005 and March 6, 2009. Two patients canceled before receiving treatment and 69 patients were therefore included in the analysis. There were 48 patients in group 1 (rituximab-sensitive) and 21 (rituximab-refractory) in group 2.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The patients were stratified by their previous response to rituximab into rituximab sensitive (group 1) or rituximab refractory (group 2) groups. Rituximab refractory was defined as no response (stable disease or progression) or a response that lasted <6 months the last time the patient received rituximab alone or rituximab with chemotherapy.

Reporting Groups
  Description
Group I: Rituximab Sensitive

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.

rituximab: 375 mg/m^2 Given IV

temsirolimus: 25 mg given IV

Group II: Rituximab Refractory

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.

rituximab: 375 mg/m^2 Given IV

temsirolimus: 25 mg given IV


Participant Flow:   Overall Study
    Group I: Rituximab Sensitive   Group II: Rituximab Refractory
STARTED   50   21 
COMPLETED   30   15 
NOT COMPLETED   20   6 
Cancel Prior to Treatment                2                0 
Adverse Event                12                1 
Withdrawal by Subject                5                0 
Physician Decision                1                3 
Death                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Group I: Rituximab Sensitive

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.

rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV

Group II: Rituximab Refractory

Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.

rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV

Total Total of all reporting groups

Baseline Measures
   Group I: Rituximab Sensitive   Group II: Rituximab Refractory   Total 
Overall Participants Analyzed 
[Units: Participants]
 48   21   69 
Age 
[Units: Years]
Median (Full Range)
 67.5 
 (51 to 86) 
 66 
 (44 to 85) 
 67 
 (44 to 86) 
Gender 
[Units: Participants]
     
Female   13   6   19 
Male   35   15   50 
Region of Enrollment 
[Units: Participants]
     
United States   48   21   69 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Response Rate (Complete and Partial Responses) as Defined by the International Workshop Criteria   [ Time Frame: Up to 12, 28-day cycles. ]

2.  Secondary:   Time to Progression   [ Time Frame: Patients were followed up to five years after registration. ]

3.  Secondary:   Duration of Response   [ Time Frame: Response duration is followed up to 5 years from registration. ]

4.  Secondary:   Toxicity   [ Time Frame: Assessed during treatment (up to 12, 28-day cycles) ]

5.  Secondary:   Overall Survival   [ Time Frame: Patients were followed for survival status for up to 5 years. ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
Group I: Rituximab Sensitive temsirolimus: 25 mg given IV
Group II: Rituximab Refractory temsirolimus: 25 mg given IV

Other Adverse Events
    Group I: Rituximab Sensitive   Group II: Rituximab Refractory
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   48/48 (100.00%)   21/21 (100.00%) 
Blood and lymphatic system disorders     
Hemoglobin decreased † 1     
# participants affected / at risk   29/48 (60.42%)   16/21 (76.19%) 
# events   143   88 
Hemolysis † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   2 
Cardiac disorders     
Left ventricular dysfunction † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   2   0 
Pericardial effusion † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Sinus tachycardia † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Ventricular tachycardia † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Ear and labyrinth disorders     
External ear pain † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Endocrine disorders     
Endocrine disorder † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Hypothyroidism † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Eye disorders     
Dry eye syndrome † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   2   9 
Eye disorder † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Eye pain † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Photophobia † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   3   0 
Watering eyes † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   4   3 
Gastrointestinal disorders     
Abdominal distension † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   2   0 
Abdominal pain † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Anal exam abnormal † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Constipation † 1     
# participants affected / at risk   6/48 (12.50%)   4/21 (19.05%) 
# events   21   9 
Diarrhea † 1     
# participants affected / at risk   16/48 (33.33%)   6/21 (28.57%) 
# events   51   10 
Dry mouth † 1     
# participants affected / at risk   2/48 (4.17%)   1/21 (4.76%) 
# events   3   5 
Dyspepsia † 1     
# participants affected / at risk   3/48 (6.25%)   0/21 (0.00%) 
# events   6   0 
Dysphagia † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Ear, nose and throat examination abnormal † 1     
# participants affected / at risk   1/48 (2.08%)   3/21 (14.29%) 
# events   3   4 
Esophageal mucositis † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Esophagitis † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Flatulence † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Gastric mucositis † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Gastroscopy abnormal † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Gingival pain † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Hemorrhoids † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Mucositis oral † 1     
# participants affected / at risk   19/48 (39.58%)   5/21 (23.81%) 
# events   47   5 
Nausea † 1     
# participants affected / at risk   11/48 (22.92%)   10/21 (47.62%) 
# events   20   25 
Oral pain † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   1   2 
Rectal hemorrhage † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Vomiting † 1     
# participants affected / at risk   3/48 (6.25%)   1/21 (4.76%) 
# events   4   2 
General disorders     
Chest pain † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   4   0 
Chills † 1     
# participants affected / at risk   2/48 (4.17%)   1/21 (4.76%) 
# events   3   1 
Disease progression † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Edema limbs † 1     
# participants affected / at risk   14/48 (29.17%)   5/21 (23.81%) 
# events   50   18 
Fatigue † 1     
# participants affected / at risk   36/48 (75.00%)   16/21 (76.19%) 
# events   170   74 
Fever † 1     
# participants affected / at risk   4/48 (8.33%)   1/21 (4.76%) 
# events   5   1 
Localized edema † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   8   0 
Pain † 1     
# participants affected / at risk   3/48 (6.25%)   0/21 (0.00%) 
# events   3   0 
Immune system disorders     
Hypersensitivity † 1     
# participants affected / at risk   3/48 (6.25%)   1/21 (4.76%) 
# events   4   1 
Infections and infestations     
Bladder infection † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Bronchitis † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   1   1 
Eye infection † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   1   1 
Gingival infection † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   1   1 
Infection † 1     
# participants affected / at risk   3/48 (6.25%)   1/21 (4.76%) 
# events   3   1 
Nail infection † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   3   0 
Pneumonia † 1     
# participants affected / at risk   3/48 (6.25%)   2/21 (9.52%) 
# events   3   3 
Sinusitis † 1     
# participants affected / at risk   2/48 (4.17%)   2/21 (9.52%) 
# events   4   2 
Skin infection † 1     
# participants affected / at risk   0/48 (0.00%)   2/21 (9.52%) 
# events   0   2 
Small intestine infection † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Upper respiratory infection † 1     
# participants affected / at risk   2/48 (4.17%)   2/21 (9.52%) 
# events   2   2 
Urinary tract infection † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Injury, poisoning and procedural complications     
Bruising † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   2   0 
Vascular access complication † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Wound dehiscence † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   2   0 
Investigations     
Alanine aminotransferase increased † 1     
# participants affected / at risk   2/48 (4.17%)   2/21 (9.52%) 
# events   2   4 
Alkaline phosphatase increased † 1     
# participants affected / at risk   7/48 (14.58%)   6/21 (28.57%) 
# events   25   7 
Aspartate aminotransferase increased † 1     
# participants affected / at risk   4/48 (8.33%)   4/21 (19.05%) 
# events   8   7 
Creatinine increased † 1     
# participants affected / at risk   6/48 (12.50%)   5/21 (23.81%) 
# events   30   16 
INR increased † 1     
# participants affected / at risk   5/48 (10.42%)   0/21 (0.00%) 
# events   19   0 
Laboratory test abnormal † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   2 
Leukocyte count decreased † 1     
# participants affected / at risk   28/48 (58.33%)   16/21 (76.19%) 
# events   174   68 
Lipase increased † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Lymphocyte count decreased † 1     
# participants affected / at risk   7/48 (14.58%)   3/21 (14.29%) 
# events   64   20 
Neutrophil count decreased † 1     
# participants affected / at risk   21/48 (43.75%)   13/21 (61.90%) 
# events   97   38 
Platelet count decreased † 1     
# participants affected / at risk   34/48 (70.83%)   15/21 (71.43%) 
# events   176   75 
Serum cholesterol increased † 1     
# participants affected / at risk   35/48 (72.92%)   15/21 (71.43%) 
# events   136   45 
Weight loss † 1     
# participants affected / at risk   13/48 (27.08%)   7/21 (33.33%) 
# events   27   26 
Metabolism and nutrition disorders     
Anorexia † 1     
# participants affected / at risk   13/48 (27.08%)   9/21 (42.86%) 
# events   27   22 
Blood bicarbonate decreased † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Blood glucose increased † 1     
# participants affected / at risk   21/48 (43.75%)   11/21 (52.38%) 
# events   45   38 
Dehydration † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   3   0 
Serum albumin decreased † 1     
# participants affected / at risk   6/48 (12.50%)   2/21 (9.52%) 
# events   12   2 
Serum calcium decreased † 1     
# participants affected / at risk   8/48 (16.67%)   2/21 (9.52%) 
# events   28   2 
Serum calcium increased † 1     
# participants affected / at risk   0/48 (0.00%)   2/21 (9.52%) 
# events   0   2 
Serum glucose decreased † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   7   0 
Serum magnesium decreased † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Serum phosphate decreased † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   2   0 
Serum potassium decreased † 1     
# participants affected / at risk   4/48 (8.33%)   4/21 (19.05%) 
# events   6   7 
Serum potassium increased † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   1   1 
Serum sodium decreased † 1     
# participants affected / at risk   5/48 (10.42%)   2/21 (9.52%) 
# events   9   5 
Serum sodium increased † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   1   6 
Serum triglycerides increased † 1     
# participants affected / at risk   37/48 (77.08%)   16/21 (76.19%) 
# events   151   63 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   7/48 (14.58%)   1/21 (4.76%) 
# events   19   1 
Arthritis † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Back pain † 1     
# participants affected / at risk   5/48 (10.42%)   1/21 (4.76%) 
# events   14   1 
Chest wall pain † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Muscle weakness † 1     
# participants affected / at risk   2/48 (4.17%)   3/21 (14.29%) 
# events   6   3 
Muscle weakness lower limb † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   3   1 
Muscle weakness upper limb † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   2   0 
Myalgia † 1     
# participants affected / at risk   5/48 (10.42%)   1/21 (4.76%) 
# events   8   2 
Neck pain † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   2   0 
Pain in extremity † 1     
# participants affected / at risk   4/48 (8.33%)   1/21 (4.76%) 
# events   4   1 
Nervous system disorders     
Dizziness † 1     
# participants affected / at risk   5/48 (10.42%)   2/21 (9.52%) 
# events   15   2 
Dysgeusia † 1     
# participants affected / at risk   12/48 (25.00%)   2/21 (9.52%) 
# events   30   6 
Headache † 1     
# participants affected / at risk   6/48 (12.50%)   2/21 (9.52%) 
# events   8   2 
Peripheral motor neuropathy † 1     
# participants affected / at risk   4/48 (8.33%)   2/21 (9.52%) 
# events   6   2 
Peripheral sensory neuropathy † 1     
# participants affected / at risk   12/48 (25.00%)   5/21 (23.81%) 
# events   41   17 
Syncope † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Tremor † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Psychiatric disorders     
Anxiety † 1     
# participants affected / at risk   3/48 (6.25%)   0/21 (0.00%) 
# events   10   0 
Confusion † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   6   1 
Depression † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   7   0 
Insomnia † 1     
# participants affected / at risk   4/48 (8.33%)   2/21 (9.52%) 
# events   7   3 
Renal and urinary disorders     
Urinary frequency † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   9   0 
Reproductive system and breast disorders     
Reproductive tract disorder † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   4   0 
Respiratory, thoracic and mediastinal disorders     
Allergic rhinitis † 1     
# participants affected / at risk   3/48 (6.25%)   3/21 (14.29%) 
# events   7   3 
Apnea † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Cough † 1     
# participants affected / at risk   9/48 (18.75%)   3/21 (14.29%) 
# events   13   12 
Dyspnea † 1     
# participants affected / at risk   8/48 (16.67%)   5/21 (23.81%) 
# events   14   9 
Epistaxis † 1     
# participants affected / at risk   4/48 (8.33%)   2/21 (9.52%) 
# events   14   6 
Hypoxia † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Laryngoscopy abnormal † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Pharyngolaryngeal pain † 1     
# participants affected / at risk   1/48 (2.08%)   3/21 (14.29%) 
# events   3   4 
Pleural effusion † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Pneumonitis † 1     
# participants affected / at risk   9/48 (18.75%)   1/21 (4.76%) 
# events   15   1 
Pulmonary hypertension † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   2 
Respiratory disorder † 1     
# participants affected / at risk   4/48 (8.33%)   1/21 (4.76%) 
# events   7   1 
Voice alteration † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   4   0 
Skin and subcutaneous tissue disorders     
Alopecia † 1     
# participants affected / at risk   2/48 (4.17%)   1/21 (4.76%) 
# events   2   12 
Dry skin † 1     
# participants affected / at risk   1/48 (2.08%)   1/21 (4.76%) 
# events   1   12 
Hand-and-foot syndrome † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Nail disorder † 1     
# participants affected / at risk   10/48 (20.83%)   3/21 (14.29%) 
# events   31   13 
Pain of skin † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Petechiae † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   2 
Pruritus † 1     
# participants affected / at risk   6/48 (12.50%)   3/21 (14.29%) 
# events   15   10 
Rash acneiform † 1     
# participants affected / at risk   3/48 (6.25%)   1/21 (4.76%) 
# events   5   1 
Rash desquamating † 1     
# participants affected / at risk   26/48 (54.17%)   12/21 (57.14%) 
# events   88   40 
Skin atrophy † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   2   0 
Skin disorder † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   7   0 
Skin hyperpigmentation † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   9   0 
Sweating † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Urticaria † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   4   0 
Vascular disorders     
Flushing † 1     
# participants affected / at risk   0/48 (0.00%)   1/21 (4.76%) 
# events   0   1 
Hemorrhage † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Hot flashes † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Hypertension † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   6   0 
Hypotension † 1     
# participants affected / at risk   2/48 (4.17%)   0/21 (0.00%) 
# events   2   0 
Phlebitis † 1     
# participants affected / at risk   1/48 (2.08%)   0/21 (0.00%) 
# events   1   0 
Thrombosis † 1     
# participants affected / at risk   3/48 (6.25%)   1/21 (4.76%) 
# events   3   2 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 6



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Stephen M. Ansell, M.D., Ph.D.
Organization: Mayo Clinic
e-mail: ansell.stephen@mayo.edu


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00109967     History of Changes
Other Study ID Numbers: NCI-2009-00644
N038H
U10CA025224 ( U.S. NIH Grant/Contract )
CDR0000425334 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: May 3, 2005
First Posted: May 4, 2005
Results First Submitted: December 3, 2013
Results First Posted: January 22, 2014
Last Update Posted: April 17, 2014