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Gemcitabine, Capecitabine, and Bevacizumab in Treating Patients With Metastatic or Unresectable Pancreatic Cancer

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ClinicalTrials.gov Identifier: NCT00100815
Recruitment Status : Completed
First Posted : January 7, 2005
Results First Posted : December 24, 2015
Last Update Posted : December 24, 2015
Sponsor:
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pancreatic Cancer
Interventions Biological: bevacizumab
Drug: capecitabine
Drug: gemcitabine hydrochloride
Enrollment 50
Recruitment Details  
Pre-assignment Details  
Arm/Group Title GEMCITABINE, CAPECITABINE and AVASTIN
Hide Arm/Group Description Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
Period Title: Overall Study
Started 50
Completed 1
Not Completed 49
Reason Not Completed
Progression             24
Adverse Event             18
Death             4
not specified             3
Arm/Group Title GEMCITABINE, CAPECITABINE and AVASTIN
Hide Arm/Group Description Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
Overall Number of Baseline Participants 50
Hide Baseline Analysis Population Description
All treated and eligible patients
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants
64.18  (11.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants
Female
22
  44.0%
Male
28
  56.0%
1.Primary Outcome
Title Progression-free Survival
Hide Description Progressive Disease is defined using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000], as at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started or the appearance of one or more new lesions, or appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
Time Frame every 2-4 months for 1 year and then every 6 months for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title GEMCITABINE, CAPECITABINE and AVASTIN
Hide Arm/Group Description:
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
Overall Number of Participants Analyzed 50
Median (95% Confidence Interval)
Unit of Measure: months
5.7
(4.2 to 7.2)
2.Secondary Outcome
Title Percentage of Participants With Grades 3-5 Treatment Related Toxicities
Hide Description Grade 3, 4 or 5 toxicity rate
Time Frame Subjects were evaluated for adverse events at each study visit for the duration of their participation in the study, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title GEMCITABINE, CAPECITABINE and AVASTIN
Hide Arm/Group Description:
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
70
(55.4 to 82.1)
3.Secondary Outcome
Title Percentage of Participants With Improved Quality of Life
Hide Description Quality of Life was assessed using EORTC QLQ-PAN26. All measures range in score from 1 to 4 as lower scores indicate better outcomes. The improved Quality of Life is defined as a greater than 5% decrease in 2 consecutive scores compared with the baseline score.
Time Frame assessed at baseline then weekly for 3 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title GEMCITABINE, CAPECITABINE and AVASTIN
Hide Arm/Group Description:
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
56.0
(41.3 to 70.0)
4.Secondary Outcome
Title Clinical Response
Hide Description Response was evaluated using the international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee [JNCI 92(3):205-216, 2000]. Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), At least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum longest diameter; Overall Response (OR) = CR + PR.
Time Frame Pre-treatment and every 6 weeks from treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title GEMCITABINE, CAPECITABINE and AVASTIN
Hide Arm/Group Description:
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
Overall Number of Participants Analyzed 50
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
22.0
(11.5 to 35.9)
5.Secondary Outcome
Title Overall Survival
Hide Description [Not Specified]
Time Frame every 2-4 months for 1 year and then every 6 months for 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients
Arm/Group Title GEMCITABINE, CAPECITABINE and AVASTIN
Hide Arm/Group Description:
Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
Overall Number of Participants Analyzed 50
Median (90% Confidence Interval)
Unit of Measure: months
9.8
(8.3 to 12.6)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GEMCITABINE, CAPECITABINE and AVASTIN
Hide Arm/Group Description Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
All-Cause Mortality
GEMCITABINE, CAPECITABINE and AVASTIN
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GEMCITABINE, CAPECITABINE and AVASTIN
Affected / at Risk (%) # Events
Total   27/50 (54.00%)    
Blood and lymphatic system disorders   
Anaemia   2/50 (4.00%)  2
Thrombocytopenia   3/50 (6.00%)  3
Cardiac disorders   
Myocardial infarction   1/50 (2.00%)  1
Eye disorders   
Blindness   1/50 (2.00%)  1
Gastrointestinal disorders   
Abdominal pain   4/50 (8.00%)  4
Constipation   1/50 (2.00%)  1
Diarrhoea   2/50 (4.00%)  2
Gastric ulcer haemorrhage   1/50 (2.00%)  1
Gastrointestinal haemorrhage   3/50 (6.00%)  5
Gastrointestinal ulcer haemorrhage   1/50 (2.00%)  1
Intestinal obstruction   1/50 (2.00%)  2
Nausea   1/50 (2.00%)  1
Vomiting   3/50 (6.00%)  5
General disorders   
Asthenia   1/50 (2.00%)  1
Death   5/50 (10.00%)  5
Device occlusion   1/50 (2.00%)  1
Fatigue   1/50 (2.00%)  1
Mucosal inflammation   1/50 (2.00%)  1
Pain   3/50 (6.00%)  3
Pyrexia   5/50 (10.00%)  6
Hepatobiliary disorders   
Hyperbilirubinaemia   1/50 (2.00%)  1
Infections and infestations   
Clostridium difficile colitis   1/50 (2.00%)  1
Diverticulitis   1/50 (2.00%)  1
Febrile infection   1/50 (2.00%)  1
Infection   1/50 (2.00%)  1
Pneumonia   2/50 (4.00%)  2
Sepsis   2/50 (4.00%)  2
Investigations   
Aspartate aminotransferase increased   1/50 (2.00%)  1
Blood alkaline phosphatase increased   1/50 (2.00%)  2
Haemoglobin   1/50 (2.00%)  1
Neutrophil count   1/50 (2.00%)  1
Metabolism and nutrition disorders   
Dehydration   4/50 (8.00%)  4
Hyperglycaemia   1/50 (2.00%)  1
Musculoskeletal and connective tissue disorders   
Back pain   2/50 (4.00%)  2
Nervous system disorders   
Balance disorder   1/50 (2.00%)  1
Headache   1/50 (2.00%)  1
Psychiatric disorders   
Confusional state   1/50 (2.00%)  1
Renal and urinary disorders   
Haematuria   1/50 (2.00%)  1
Reproductive system and breast disorders   
Female genital tract fistula   1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Epistaxis   2/50 (4.00%)  2
Lung infiltration   1/50 (2.00%)  1
Pulmonary embolism   2/50 (4.00%)  2
Vascular disorders   
Deep vein thrombosis   2/50 (4.00%)  2
Haemorrhage   1/50 (2.00%)  1
Hypertension   1/50 (2.00%)  1
Thrombophlebitis superficial   1/50 (2.00%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GEMCITABINE, CAPECITABINE and AVASTIN
Affected / at Risk (%) # Events
Total   47/50 (94.00%)    
Blood and lymphatic system disorders   
Anaemia   18/50 (36.00%)  29
Leukopenia   6/50 (12.00%)  9
Lymphopenia   3/50 (6.00%)  4
Neutropenia   16/50 (32.00%)  31
Spleen disorder   1/50 (2.00%)  1
Thrombocytopenia   7/50 (14.00%)  16
Cardiac disorders   
Arrhythmia   1/50 (2.00%)  1
Cardiomegaly   1/50 (2.00%)  1
Tachycardia   1/50 (2.00%)  1
Ear and labyrinth disorders   
Ear pain   1/50 (2.00%)  1
Tinnitus   1/50 (2.00%)  1
Eye disorders   
Eye swelling   1/50 (2.00%)  1
Gastrointestinal disorders   
Abdominal distension   2/50 (4.00%)  2
Abdominal pain   13/50 (26.00%)  14
Abdominal pain lower   1/50 (2.00%)  1
Abdominal pain upper   1/50 (2.00%)  1
Chapped lips   1/50 (2.00%)  1
Colitis   3/50 (6.00%)  3
Constipation   13/50 (26.00%)  16
Diarrhoea   17/50 (34.00%)  24
Dry mouth   2/50 (4.00%)  2
Dyspepsia   1/50 (2.00%)  1
Dysphagia   3/50 (6.00%)  3
Faecaloma   1/50 (2.00%)  1
Faeces discoloured   1/50 (2.00%)  1
Flatulence   3/50 (6.00%)  3
Gastric varices   1/50 (2.00%)  1
Gastrooesophageal reflux disease   1/50 (2.00%)  1
Gingival bleeding   1/50 (2.00%)  1
Gingival polyp   1/50 (2.00%)  1
Glossodynia   1/50 (2.00%)  1
Haemorrhoidal haemorrhage   1/50 (2.00%)  1
Haemorrhoids   1/50 (2.00%)  1
Nausea   21/50 (42.00%)  28
Oesophagitis   1/50 (2.00%)  1
Oral pain   5/50 (10.00%)  6
Rectal haemorrhage   1/50 (2.00%)  1
Stomatitis   7/50 (14.00%)  13
Toothache   1/50 (2.00%)  1
Vomiting   11/50 (22.00%)  12
General disorders   
Asthenia   4/50 (8.00%)  5
Chest pain   3/50 (6.00%)  3
Chills   7/50 (14.00%)  7
Device occlusion   4/50 (8.00%)  4
Fatigue   30/50 (60.00%)  44
Influenza like illness   2/50 (4.00%)  2
Local swelling   1/50 (2.00%)  1
Mucosal inflammation   3/50 (6.00%)  3
Oedema   11/50 (22.00%)  15
Oedema peripheral   4/50 (8.00%)  5
Pain   12/50 (24.00%)  14
Pyrexia   9/50 (18.00%)  14
Hepatobiliary disorders   
Bile duct obstruction   1/50 (2.00%)  1
Cholangitis   1/50 (2.00%)  1
Cholelithiasis   1/50 (2.00%)  1
Hyperbilirubinaemia   1/50 (2.00%)  3
Infections and infestations   
Cellulitis   1/50 (2.00%)  1
Cystitis   1/50 (2.00%)  1
Device related infection   1/50 (2.00%)  1
Infection   2/50 (4.00%)  2
Influenza   2/50 (4.00%)  2
Pneumonia   1/50 (2.00%)  1
Sinusitis   1/50 (2.00%)  1
Injury, poisoning and procedural complications   
Fall   1/50 (2.00%)  1
Limb injury   1/50 (2.00%)  2
Wound complication   1/50 (2.00%)  1
Investigations   
Alanine aminotransferase increased   11/50 (22.00%)  18
Antineutrophil cytoplasmic antibody   1/50 (2.00%)  1
Aspartate aminotransferase increased   13/50 (26.00%)  25
Blood albumin   15/50 (30.00%)  18
Blood albumin decreased   4/50 (8.00%)  4
Blood alkaline phosphatase   16/50 (32.00%)  31
Blood alkaline phosphatase increased   3/50 (6.00%)  3
Blood amylase increased   1/50 (2.00%)  1
Blood bicarbonate   6/50 (12.00%)  6
Blood bilirubin   10/50 (20.00%)  18
Blood bilirubin increased   1/50 (2.00%)  2
Blood calcium   8/50 (16.00%)  10
Blood chloride   5/50 (10.00%)  6
Blood creatinine   7/50 (14.00%)  7
Blood creatinine decreased   1/50 (2.00%)  1
Blood creatinine increased   1/50 (2.00%)  1
Blood glucose   6/50 (12.00%)  18
Blood lactate dehydrogenase   4/50 (8.00%)  5
Blood lactate dehydrogenase increased   1/50 (2.00%)  1
Blood potassium   12/50 (24.00%)  19
Blood potassium increased   1/50 (2.00%)  1
Blood pressure   6/50 (12.00%)  8
Blood sodium   7/50 (14.00%)  8
Blood urea   6/50 (12.00%)  6
Blood uric acid decreased   4/50 (8.00%)  5
Blood uric acid increased   4/50 (8.00%)  4
Carbon dioxide abnormal   1/50 (2.00%)  1
Creatinine renal clearance   1/50 (2.00%)  2
Haematocrit   6/50 (12.00%)  7
Haemoglobin   20/50 (40.00%)  30
Haemoglobin decreased   2/50 (4.00%)  2
International normalised ratio   4/50 (8.00%)  5
International normalised ratio increased   1/50 (2.00%)  1
Lipase   1/50 (2.00%)  1
Liver function test   1/50 (2.00%)  1
Lymphocyte count   1/50 (2.00%)  2
Lymphocyte count abnormal   1/50 (2.00%)  1
Neutrophil count   17/50 (34.00%)  31
Neutrophil count decreased   1/50 (2.00%)  1
Platelet count   13/50 (26.00%)  20
Platelet count decreased   5/50 (10.00%)  6
Platelet count increased   2/50 (4.00%)  3
Protein total   4/50 (8.00%)  5
Protein total decreased   3/50 (6.00%)  3
Protein urine   1/50 (2.00%)  1
Prothrombin time prolonged   1/50 (2.00%)  1
Red blood cell count   11/50 (22.00%)  14
Urine output increased   1/50 (2.00%)  1
Weight   1/50 (2.00%)  1
Weight decreased   13/50 (26.00%)  17
White blood cell count   16/50 (32.00%)  22
White blood cell count abnormal   1/50 (2.00%)  1
White blood cell count decreased   5/50 (10.00%)  6
White blood cell count increased   2/50 (4.00%)  2
Metabolism and nutrition disorders   
Decreased appetite   16/50 (32.00%)  18
Dehydration   7/50 (14.00%)  9
Hyperalbuminaemia   1/50 (2.00%)  1
Hyperglycaemia   21/50 (42.00%)  30
Hyperkalaemia   5/50 (10.00%)  6
Hypernatraemia   2/50 (4.00%)  2
Hypoalbuminaemia   5/50 (10.00%)  16
Hypoglycaemia   2/50 (4.00%)  3
Hypokalaemia   4/50 (8.00%)  4
Hyponatraemia   4/50 (8.00%)  4
Musculoskeletal and connective tissue disorders   
Arthralgia   1/50 (2.00%)  2
Back pain   6/50 (12.00%)  6
Bone pain   1/50 (2.00%)  1
Joint swelling   1/50 (2.00%)  1
Muscular weakness   1/50 (2.00%)  1
Nervous system disorders   
Ageusia   1/50 (2.00%)  1
Dizziness   9/50 (18.00%)  9
Dysarthria   1/50 (2.00%)  1
Dysgeusia   1/50 (2.00%)  1
Headache   4/50 (8.00%)  5
Neuropathy peripheral   1/50 (2.00%)  1
Paraesthesia   1/50 (2.00%)  1
Psychiatric disorders   
Anxiety   1/50 (2.00%)  1
Depressed mood   1/50 (2.00%)  1
Depression   3/50 (6.00%)  3
Dysphoria   2/50 (4.00%)  2
Insomnia   4/50 (8.00%)  5
Restlessness   1/50 (2.00%)  1
Renal and urinary disorders   
Micturition urgency   1/50 (2.00%)  1
Nephrotic syndrome   1/50 (2.00%)  1
Pollakiuria   2/50 (4.00%)  2
Proteinuria   2/50 (4.00%)  3
Reproductive system and breast disorders   
Erectile dysfunction   1/50 (2.00%)  1
Pelvic pain   1/50 (2.00%)  1
Respiratory, thoracic and mediastinal disorders   
Cough   3/50 (6.00%)  5
Dysphonia   2/50 (4.00%)  2
Dyspnoea   8/50 (16.00%)  11
Epistaxis   5/50 (10.00%)  5
Hiccups   2/50 (4.00%)  3
Lung infiltration   1/50 (2.00%)  1
Nasal congestion   1/50 (2.00%)  1
Paranasal sinus discomfort   1/50 (2.00%)  1
Pneumonitis   1/50 (2.00%)  1
Pulmonary congestion   1/50 (2.00%)  2
Pulmonary embolism   2/50 (4.00%)  2
Rhinorrhoea   1/50 (2.00%)  1
Wheezing   1/50 (2.00%)  1
Skin and subcutaneous tissue disorders   
Alopecia   2/50 (4.00%)  2
Dry skin   1/50 (2.00%)  1
Hyperhidrosis   1/50 (2.00%)  1
Night sweats   1/50 (2.00%)  1
Palmar-plantar erythrodysaesthesia syndrome   8/50 (16.00%)  14
Pruritus   1/50 (2.00%)  1
Rash   6/50 (12.00%)  6
Skin ulcer   1/50 (2.00%)  1
Yellow skin   1/50 (2.00%)  1
Vascular disorders   
Deep vein thrombosis   2/50 (4.00%)  2
Hot flush   1/50 (2.00%)  1
Hypertension   16/50 (32.00%)  27
Hypotension   5/50 (10.00%)  6
Orthostatic hypotension   3/50 (6.00%)  3
Phlebitis   1/50 (2.00%)  1
Subclavian vein thrombosis   1/50 (2.00%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT00100815     History of Changes
Other Study ID Numbers: CDR0000409556
RPCI-I-19903
GENENTECH-RPCI-I-19903
First Submitted: January 6, 2005
First Posted: January 7, 2005
Results First Submitted: September 28, 2015
Results First Posted: December 24, 2015
Last Update Posted: December 24, 2015