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Gemcitabine, Infusional 5 Fluorouracil and Bevacizumab in Patients With Advanced Pancreas Cancer

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ClinicalTrials.gov Identifier: NCT00417976
Recruitment Status : Completed
First Posted : January 4, 2007
Results First Posted : November 3, 2014
Last Update Posted : October 1, 2015
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Drug: Gemcitabine
Drug: Bevacizumab
Drug: Infusional 5-Fluorouracil
Enrollment 42
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Bevacizumab
Hide Arm/Group Description

Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.

Bevacizumab : 10 mg/kg every 2 weeks.

Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks.

Period Title: Overall Study
Started 42
Completed 39
Not Completed 3
Reason Not Completed
Non compliance unrelated to toxicity             1
Treatment -related toxicity             2
Arm/Group Title Bevacizumab
Hide Arm/Group Description

Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.

Bevacizumab : 10 mg/kg every 2 weeks.

Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks.

Overall Number of Baseline Participants 42
Hide Baseline Analysis Population Description
42 patients enrolled in study; of which, 39 were evaluable for primary end point.
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 42 participants
60
(36 to 79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Female
23
  54.8%
Male
19
  45.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 42 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
40
  95.2%
Unknown or Not Reported
2
   4.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 42 participants
42
Eastern Cooperative Oncology Group (ECOG) Performance status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
0 (Fully Active) 15
1 (Restricted in physical activity) 27
Site of metastasis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
Liver only 29
Liver+other 2
Other only 9
Recurrent metastatic disease 2
Prior adjuvant therapy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
Gemcitabine-based 1
Chemoraditation 1
No prior adjuvant therapy 40
Disease stage  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
III (Unresectable primary tumor) 2
IV (Cancer has spread o distant tissue or organ) 40
CA19-9 (tumor marker levels)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
Normal (≤37 U/ml) 6
Elevated (>37 U/ml) 36
Albumin  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 42 participants
Normal (≥3.4 g/dl) 28
Low (<3.4 g/dl) 14
1.Primary Outcome
Title Rate of Progression Free Survival at 6 Months (24 Weeks) From Initiation of Therapy
Hide Description [Not Specified]
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab
Hide Arm/Group Description:

Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.

Bevacizumab : 10 mg/kg every 2 weeks.

Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks.

Overall Number of Participants Analyzed 39
Measure Type: Number
Unit of Measure: percent of patients
49
2.Secondary Outcome
Title Response Rates Defined by RECIST 1.0
Hide Description The National Cancer Institutes Response Evaluation Criteria in Solid Tumors (RECIST) 1.0 was used in accessing response for patients
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Bevacizumab
Hide Arm/Group Description:

Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.

Bevacizumab: 10 mg/kg every 2 weeks.

Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks.

Overall Number of Participants Analyzed 40
Measure Type: Number
Unit of Measure: patients
Complete Respsonse 0
Partial Response 12
Stable Disease 18
Progressive Disease 10
Time Frame Adverse events were graded according to the NCI-CTCAE (Common Toxicity Criteria for Adverse Effects) v 3.0. Toxicity assessments were repeated on day 1 and 15 of every cycle.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Bevacizumab
Hide Arm/Group Description

Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.

Bevacizumab: 10 mg/kg every 2 weeks.

Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks.

All-Cause Mortality
Bevacizumab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Bevacizumab
Affected / at Risk (%) # Events
Total   1/42 (2.38%)    
Blood and lymphatic system disorders   
Anemia  1  1/42 (2.38%)  1
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 2%
Bevacizumab
Affected / at Risk (%) # Events
Total   42/42 (100.00%)    
Blood and lymphatic system disorders   
Anemia  1  27/42 (64.29%)  27
Gastrointestinal disorders   
Vomiting  1  33/42 (78.57%)  33
Nausea  1  25/42 (59.52%)  25
Diarrhea  1  16/42 (38.10%)  16
Mucositis  1  9/42 (21.43%)  9
Fistula formation  1  1/42 (2.38%)  1
General disorders   
Fatigue  1  26/42 (61.90%)  26
Injury, poisoning and procedural complications   
Thrombocytopenia  1  13/42 (30.95%)  13
Investigations   
Leukopenia  1  11/42 (26.19%)  11
Neutropenia  1  6/42 (14.29%)  6
Lymphopenia  1  8/42 (19.05%)  8
Elevated ALT, SGPT (serum glutamic pyruvic transaminase)  1  7/42 (16.67%)  7
Elevated AST, SGOT(serum glutamic oxaloacetic transaminase)  1  6/42 (14.29%)  6
Nervous system disorders   
Altered sense of taste  1  12/42 (28.57%)  12
Headache  1  5/42 (11.90%)  5
Peripheral sensory neuropathy  1  6/42 (14.29%)  6
Renal and urinary disorders   
Proteinuria  1  3/42 (7.14%)  3
Skin and subcutaneous tissue disorders   
Rash  1  5/42 (11.90%)  5
Vascular disorders   
Hypertension  1  8/42 (19.05%)  8
Bleeding  1  7/42 (16.67%)  7
Thrombosis  1  2/42 (4.76%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
42 patients enrolled, 39 were evaluable for the primary end point.
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
Layout table for Results Point of Contact information
Name/Title: Tanios Bekaii-Saab
Organization: The Ohio State University
Phone: 614-293-9863
EMail: Tanios.saab@osumc.edu
Layout table for additonal information
Responsible Party: Tony Bekaii-Saab, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00417976     History of Changes
Other Study ID Numbers: OSU-05110
NCI-2011-03230 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: January 2, 2007
First Posted: January 4, 2007
Results First Submitted: May 19, 2014
Results First Posted: November 3, 2014
Last Update Posted: October 1, 2015