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Lenalidomide With Gemcitabine in Treatment of Untreated Advanced Carcinoma of the Pancreas

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ClinicalTrials.gov Identifier: NCT00837031
Recruitment Status : Completed
First Posted : February 5, 2009
Results First Posted : March 13, 2013
Last Update Posted : March 13, 2013
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Pancreatic Cancer
Interventions Drug: Lenalidomide
Drug: Gemcitabine
Enrollment 72
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Lenalidomide/Gemcitabine
Hide Arm/Group Description The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
Period Title: Overall Study
Started 72
Completed 72
Not Completed 0
Arm/Group Title Lenalidomide/Gemcitabine
Hide Arm/Group Description The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
Overall Number of Baseline Participants 72
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 72 participants
64
(39 to 88)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants
Female
23
  31.9%
Male
49
  68.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 72 participants
72
1.Primary Outcome
Title Six-Month Overall Survival (OS) Probability, the Percentage of Patients Estimated to be Alive Six Months After Beginning Protocol Treatment
Hide Description The percentage of patients who were alive 6 months after beginning treatment
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide/Gemcitabine
Hide Arm/Group Description:
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
Overall Number of Participants Analyzed 72
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
37
(26 to 48)
2.Secondary Outcome
Title Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease
Hide Description The length of time, in months, that patients were alive from their first date of protocol treatment until worsening of their disease
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide/Gemcitabine
Hide Arm/Group Description:
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
Overall Number of Participants Analyzed 72
Median (95% Confidence Interval)
Unit of Measure: months
2.3
(1.9 to 3.5)
3.Secondary Outcome
Title Overall Survival (OS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
Hide Description Length of time, in months, that patients were alive from their first date of protocol treatment until death
Time Frame 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Lenalidomide/Gemcitabine
Hide Arm/Group Description:
The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
Overall Number of Participants Analyzed 56
Median (95% Confidence Interval)
Unit of Measure: months
4.7
(3.4 to 5.7)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Lenalidomide/Gemcitabine
Hide Arm/Group Description The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15). After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
All-Cause Mortality
Lenalidomide/Gemcitabine
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Lenalidomide/Gemcitabine
Affected / at Risk (%) # Events
Total   8/72 (11.11%)    
Blood and lymphatic system disorders   
Hemorrhage  1  1/72 (1.39%)  1
Splenic Abscess  1  1/72 (1.39%)  1
Cardiac disorders   
Supraventricular arrhythmia - Atrial fibrillation  1  1/72 (1.39%)  1
Gastrointestinal disorders   
Perforation, GI  1  1/72 (1.39%)  1
General disorders   
Weakness  1  1/72 (1.39%)  1
Death  1  3/72 (4.17%)  3
Infections and infestations   
Infection - Sepsis  1  1/72 (1.39%)  1
Metabolism and nutrition disorders   
Hypokalemia  1  1/72 (1.39%)  1
Hyperbilirubinemia  1  1/72 (1.39%)  1
Nervous system disorders   
Syncope  1  1/72 (1.39%)  1
Renal and urinary disorders   
Renal Failure  1  1/72 (1.39%)  1
Vascular disorders   
Thrombosis/Thrombus/Embolism  1  2/72 (2.78%)  2
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 5%
Lenalidomide/Gemcitabine
Affected / at Risk (%) # Events
Total   71/72 (98.61%)    
Blood and lymphatic system disorders   
Neutrophils  1  27/72 (37.50%)  91
Edema - limb  1  23/72 (31.94%)  32
Hemoglobin  1  45/72 (62.50%)  111
Leukocytes  1  24/72 (33.33%)  77
Platelets  1  41/72 (56.94%)  147
Cardiac disorders   
Hypotension  1  8/72 (11.11%)  9
Gastrointestinal disorders   
Anorexia  1  27/72 (37.50%)  37
Constipation  1  25/72 (34.72%)  33
Dehydration  1  13/72 (18.06%)  25
Diarrhea  1  21/72 (29.17%)  32
Nausea  1  33/72 (45.83%)  51
Taste alteration  1  6/72 (8.33%)  7
Vomiting  1  15/72 (20.83%)  21
General disorders   
Fatigue  1  46/72 (63.89%)  88
Fever  1  11/72 (15.28%)  18
Pain - abdomen  1  30/72 (41.67%)  46
Pain - back  1  13/72 (18.06%)  15
Pain - chest  1  12/72 (16.67%)  21
Pain - headache  1  7/72 (9.72%)  9
Pain - limb  1  9/72 (12.50%)  14
Pain - stomach  1  5/72 (6.94%)  6
Weakness  1  11/72 (15.28%)  21
Weight loss  1  11/72 (15.28%)  17
Hepatobiliary disorders   
Jaundice  1  5/72 (6.94%)  7
Infections and infestations   
Infection - urinary tract  1  4/72 (5.56%)  4
Metabolism and nutrition disorders   
Alkaline phosphatase  1  10/72 (13.89%)  16
ALT  1  14/72 (19.44%)  17
Hyperbilirubinemia  1  9/72 (12.50%)  15
Hyperglycemia  1  8/72 (11.11%)  12
Hypocalcemia  1  6/72 (8.33%)  12
Hypokalemia  1  12/72 (16.67%)  24
Hyponatremia  1  9/72 (12.50%)  14
Nervous system disorders   
Chills  1  7/72 (9.72%)  7
Dizziness  1  11/72 (15.28%)  15
Insomnia  1  6/72 (8.33%)  9
Neuropathy - sensory  1  8/72 (11.11%)  10
Tremor  1  4/72 (5.56%)  5
Psychiatric disorders   
Anxiety  1  6/72 (8.33%)  8
Confusion  1  7/72 (9.72%)  8
Depression  1  5/72 (6.94%)  5
Respiratory, thoracic and mediastinal disorders   
Cough  1  9/72 (12.50%)  12
Dyspnea  1  17/72 (23.61%)  20
Skin and subcutaneous tissue disorders   
Pruritis  1  4/72 (5.56%)  5
Rash  1  22/72 (30.56%)  33
Vascular disorders   
Thrombus/thrombosis/embolism  1  20/72 (27.78%)  27
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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 sponsor can review/embargo results communications prior to public release for a period that is >60 days but ≤180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00837031     History of Changes
Other Study ID Numbers: SCRI GI 106
First Submitted: February 4, 2009
First Posted: February 5, 2009
Results First Submitted: February 8, 2013
Results First Posted: March 13, 2013
Last Update Posted: March 13, 2013