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Gemcitabine and Erlotinib in Treating Patients With Metastatic or Recurrent Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00810719
Recruitment Status : Completed
First Posted : December 18, 2008
Results First Posted : March 7, 2017
Last Update Posted : January 10, 2018
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Genentech, Inc.
Information provided by (Responsible Party):
University of California, Davis

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Erlotinib
Drug: gemcitabine
Enrollment 30

Recruitment Details Patients were enrolled at University of California Davis and the University of Southern California.
Pre-assignment Details  
Arm/Group Title Gemcitabine and Erlotinib
Hide Arm/Group Description

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.

Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.

gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.

Period Title: Overall Study
Started 30
Completed 30
Not Completed 0
Arm/Group Title Gemcitabine and Erlotinib
Hide Arm/Group Description

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.

Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.

gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.

Overall Number of Baseline Participants 30
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 30 participants
67
(46 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants
Female
15
  50.0%
Male
15
  50.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 30 participants
30
1.Primary Outcome
Title Progression Free Survival
Hide Description Defined as the time from first day of treatment to the first observation of disease progression or death due to any cause. If a patient has not progressed or died, progression-free survival is censored at the time of last follow-up. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine and Erlotinib
Hide Arm/Group Description:

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.

Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.

gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.

Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
2.07
(1.87 to 5.50)
2.Secondary Outcome
Title Response Rate
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Two patients withdrew consent in the first cycle and were not evaluable for response.
Arm/Group Title Gemcitabine and Erlotinib
Hide Arm/Group Description:

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.

Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.

gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of participants
11
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival will be followed for survival every three months until documented progression, death or study termination. If a participant is still alive, survival time is censored at the time of last follow-up.
Time Frame Up to 36 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine and Erlotinib
Hide Arm/Group Description:

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.

Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.

gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.

Overall Number of Participants Analyzed 30
Median (95% Confidence Interval)
Unit of Measure: months
5.67
(2.83 to 11.87)
Time Frame Up to 36 months
Adverse Event Reporting Description Start of study treatment and ends 30 days following the last administration of study treatment or study discontinuation/termination, whichever is earlier.
 
Arm/Group Title Gemcitabine and Erlotinib
Hide Arm/Group Description

The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.Erlotinib will be dosed at 150mg orally (tablets) on days 2-5, 9-12, and 16-26 of a 28 day cycle.

Erlotinib: Erlotinib will be administered at 150 mg once daily by mouth on the following schedule: days 2-5, 9-12,16-26.

gemcitabine: The dose for gemcitabine is 1,000 mg/m2 administered over 30 minutes as an intravenous infusion. The doses are administered weekly for 3 weeks (Days 1, 8 and 15) followed by one week of rest during which gemcitabine is not given. This 4 week period (28 days) constitutes a cycle.

All-Cause Mortality
Gemcitabine and Erlotinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine and Erlotinib
Affected / at Risk (%) # Events
Total   6/30 (20.00%)    
Gastrointestinal disorders   
Nausea  1  1/30 (3.33%) 
Dehydration  1  1/30 (3.33%) 
Diarrhea  1  1/30 (3.33%) 
General disorders   
Fatigue  1  2/30 (6.67%) 
Infections and infestations   
Lung Infection  1  1/30 (3.33%) 
Psychiatric disorders   
Mental Status Changes * 1  1/30 (3.33%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  2/30 (6.67%) 
Pneumonitis  1  1/30 (3.33%)  1
Skin and subcutaneous tissue disorders   
Acne  1  1/30 (3.33%) 
Skin Infection  1  1/30 (3.33%) 
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-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 2%
Gemcitabine and Erlotinib
Affected / at Risk (%) # Events
Total   30/30 (100.00%)    
Blood and lymphatic system disorders   
Hemoglobin  1  17/30 (56.67%) 
Leukopenia  1  13/30 (43.33%) 
Lymphopenia  1  13/30 (43.33%) 
Neutropenia  1  13/30 (43.33%) 
Thrombocytopenia  1  17/30 (56.67%) 
Gastrointestinal disorders   
Anorexia  1  7/30 (23.33%) 
Dehydration  1  4/30 (13.33%) 
Diarrhea  1  9/30 (30.00%) 
Mucositis  1  8/30 (26.67%) 
Nausea  1  9/30 (30.00%) 
Taste Alteration  1  4/30 (13.33%) 
Vomiting  1  3/30 (10.00%) 
General disorders   
Fatigue  1  8/30 (26.67%) 
Weight Loss  1  5/30 (16.67%) 
Metabolism and nutrition disorders   
Hypoalbuminemia  1  5/30 (16.67%) 
Alkaline Phosphatase  1  8/30 (26.67%) 
ALT  1  8/30 (26.67%) 
AST  1  8/30 (26.67%) 
Hyperbilirubinemia  1  9/30 (30.00%) 
Hypokalemia  1  3/30 (10.00%) 
Hyponatremia  1  2/30 (6.67%) 
Musculoskeletal and connective tissue disorders   
Muscle Weakness  1  3/30 (10.00%) 
Respiratory, thoracic and mediastinal disorders   
Dyspnea  1  1/30 (3.33%) 
Skin and subcutaneous tissue disorders   
Dry Skin  1  5/30 (16.67%) 
Pruritis  1  2/30 (6.67%) 
Rash  1  16/30 (53.33%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Due to funding considerations, the study was closed after thirty participants were enrolled.
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: Analyst
Organization: University of California Davis
Phone: 916 734 0294
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00810719     History of Changes
Other Study ID Numbers: UCDCC#211
232494 ( Other Identifier: UC Davis )
OSI 4132s ( Other Identifier: Genentech )
P30CA093373 ( U.S. NIH Grant/Contract )
First Submitted: December 17, 2008
First Posted: December 18, 2008
Results First Submitted: January 13, 2017
Results First Posted: March 7, 2017
Last Update Posted: January 10, 2018