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A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers

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ClinicalTrials.gov Identifier: NCT01661114
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : February 4, 2016
Last Update Posted : October 19, 2016
Sponsor:
Information provided by (Responsible Party):
University of Michigan Rogel Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Pancreatic Cancer
Biliary Cancer
Interventions Drug: Gemcitabine
Drug: 5-FU
Drug: Cisplatin
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemcitabine, 5-FU and Cisplatin
Hide Arm/Group Description 4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
Period Title: Overall Study
Started 39
Completed 39
Not Completed 0
Arm/Group Title Gemcitabine, 5-FU and Cisplatin
Hide Arm/Group Description 4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
Overall Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 39 participants
61
(25 to 80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
16
  41.0%
Male
23
  59.0%
1.Primary Outcome
Title The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment
Hide Description

The primary objective of this clinical trial is to estimate the response rate to treatment with the triplet chemotherapy regimen of gemcitabine, infusional 5-FU, and cisplatin, in untreated and previously treated advanced pancreatic and biliary cancer patients.

Partial Response (PR) is defined as At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.
Arm/Group Title Gemcitabine, 5-FU and Cisplatin
Hide Arm/Group Description:
4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
Overall Number of Participants Analyzed 39
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
Untreated
40
(21.1 to 61.3)
Received Previous Treatment
7.1
(1.8 to 33.9)
2.Secondary Outcome
Title Median Overall Survival of Previously Treated and Previously Untreated Patients
Hide Description To assess the overall survival following treatment with gemcitabine, 5-FU and cisplatin.
Time Frame 1 year
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.
Arm/Group Title Gemcitabine, 5-FU and Cisplatin
Hide Arm/Group Description:
4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
Overall Number of Participants Analyzed 39
Median (95% Confidence Interval)
Unit of Measure: Months
Previously Untreated
10.3
(8 to 19.4)
Previously Treated
4.9
(3.6 to 11.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemcitabine, 5-FU and Cisplatin
Hide Arm/Group Description 4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
All-Cause Mortality
Gemcitabine, 5-FU and Cisplatin
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine, 5-FU and Cisplatin
Affected / at Risk (%) # Events
Total   10/39 (25.64%)    
Gastrointestinal disorders   
Anal Ulcer  1/39 (2.56%)  1
Duodenal obstruction  1/39 (2.56%)  1
Duodenal ulcer  1/39 (2.56%)  1
Gastrointestinal disorders - Other  1/39 (2.56%)  1
Lower gastrointestinal hemorrhage  1/39 (2.56%)  1
Nausea  2/39 (5.13%)  2
Vomiting  1/39 (2.56%)  1
General disorders   
Chills  1/39 (2.56%)  1
Fatigue  1/39 (2.56%)  1
Fever  2/39 (5.13%)  2
Infections and infestations   
Infections and infestations - Other  2/39 (5.13%)  2
Joint infection  1/39 (2.56%)  1
Upper respiratory infection  1/39 (2.56%)  1
Injury, poisoning and procedural complications   
Hip fracture  1/39 (2.56%)  1
Spinal fracture  1/39 (2.56%)  1
Nervous system disorders   
Intracranial hemorrhage  1/39 (2.56%)  1
Syncope  2/39 (5.13%)  2
Respiratory, thoracic and mediastinal disorders   
Pneumonitis  1/39 (2.56%)  1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gemcitabine, 5-FU and Cisplatin
Affected / at Risk (%) # Events
Total   39/39 (100.00%)    
Blood and lymphatic system disorders   
Anemia  36/39 (92.31%)  49
Cardiac disorders   
Palpitations  1/39 (2.56%)  1
Supraventricular tachycardia  1/39 (2.56%)  2
Ear and labyrinth disorders   
Ear and labyrinth disorders - Other  1/39 (2.56%)  1
Hearing impaired  1/39 (2.56%)  1
Eye disorders   
Blurred vision  3/39 (7.69%)  3
Eye pain  1/39 (2.56%)  1
Gastrointestinal disorders   
Abdominal distension  1/39 (2.56%)  1
Abdominal pain  8/39 (20.51%)  9
Anal ulcer  1/39 (2.56%)  1
Bloating  1/39 (2.56%)  1
Cheilitis  1/39 (2.56%)  1
Constipation  12/39 (30.77%)  14
Diarrhea  13/39 (33.33%)  18
Dry mouth  3/39 (7.69%)  3
Duodenal obstruction  2/39 (5.13%)  2
Duodenal ulcer  1/39 (2.56%)  1
Dyspepsia  1/39 (2.56%)  1
Dysphagia  1/39 (2.56%)  1
Enterocolitis  1/39 (2.56%)  1
Flatulence  3/39 (7.69%)  3
Gastroesophageal reflux disease  1/39 (2.56%)  1
Gastrointestinal disorders - Other  1/39 (2.56%)  1
Lower gastrointestinal hemorrhage  1/39 (2.56%)  1
Mucositis oral  6/39 (15.38%)  6
Nausea  24/39 (61.54%)  38
Oral dysesthesia  1/39 (2.56%)  1
Oral pain  1/39 (2.56%)  1
Pancreatitis  1/39 (2.56%)  1
Vomiting  15/39 (38.46%)  23
General disorders   
Chills  3/39 (7.69%)  4
Edema face  1/39 (2.56%)  1
Edema limbs  4/39 (10.26%)  4
Facial pain  1/39 (2.56%)  1
Fatigue  26/39 (66.67%)  36
Fever  9/39 (23.08%)  10
Flu like symptoms  1/39 (2.56%)  1
Localized edema  1/39 (2.56%)  1
Neck edema  3/39 (7.69%)  3
Non-cardiac chest pain  3/39 (7.69%)  4
Pain  4/39 (10.26%)  4
Infections and infestations   
Appendicitis  1/39 (2.56%)  1
Eye infection  1/39 (2.56%)  1
Infections and infestations - Other  2/39 (5.13%)  2
Joint infection  1/39 (2.56%)  1
Mucosal infection  1/39 (2.56%)  1
Papulopustular rash  1/39 (2.56%)  1
Tooth infection  2/39 (5.13%)  3
Upper respiratory infection  4/39 (10.26%)  5
Urinary tract infection  1/39 (2.56%)  1
Injury, poisoning and procedural complications   
Hip fracture  1/39 (2.56%)  1
Spinal fracture  1/39 (2.56%)  1
Investigations   
Alanine aminotransferase increased  7/39 (17.95%)  12
Alkaline phosphatase increased  10/39 (25.64%)  12
Aspartate aminotransferase increased  8/39 (20.51%)  11
Blood bilirubin increased  6/39 (15.38%)  10
Creatinine increased  5/39 (12.82%)  6
Lipase increased  1/39 (2.56%)  1
Lymphocyte count decreased  29/39 (74.36%)  44
Neutrophil count decreased  27/39 (69.23%)  50
Platelet count decreased  29/39 (74.36%)  53
Serum amylase increased  1/39 (2.56%)  1
Weight gain  2/39 (5.13%)  3
Weight loss  11/39 (28.21%)  14
White blood cell decreased  31/39 (79.49%)  65
Metabolism and nutrition disorders   
Anorexia  13/39 (33.33%)  14
Hypercalcemia  1/39 (2.56%)  1
Hyperglycemia  21/39 (53.85%)  29
Hyperkalemia  4/39 (10.26%)  5
Hypoalbuminemia  11/39 (28.21%)  13
Hypocalcemia  13/39 (33.33%)  18
Hypoglycemia  1/39 (2.56%)  1
Hypokalemia  7/39 (17.95%)  8
Hypomagnesemia  4/39 (10.26%)  4
Hyponatremia  15/39 (38.46%)  19
Hypophosphatemia  2/39 (5.13%)  2
Musculoskeletal and connective tissue disorders   
Arthralgia  1/39 (2.56%)  1
Back pain  5/39 (12.82%)  5
Bone pain  1/39 (2.56%)  1
Flank pain  2/39 (5.13%)  2
Generalized muscle weakness  2/39 (5.13%)  2
Musculoskeletal and connective tissue disorder - Other  2/39 (5.13%)  2
Neck pain  3/39 (7.69%)  3
Pain in extremity  5/39 (12.82%)  6
Trismus  1/39 (2.56%)  1
Nervous system disorders   
Dizziness  7/39 (17.95%)  7
Dysgeusia  2/39 (5.13%)  2
Headache  6/39 (15.38%)  6
Intracranial hemorrhage  1/39 (2.56%)  1
Memory impairment  1/39 (2.56%)  1
Peripheral sensory neuropathy  9/39 (23.08%)  9
Syncope  3/39 (7.69%)  3
Tremor  1/39 (2.56%)  1
Psychiatric disorders   
Agitation  1/39 (2.56%)  1
Anxiety  7/39 (17.95%)  9
Depression  4/39 (10.26%)  4
Renal and urinary disorders   
Urinary retention  2/39 (5.13%)  2
Urine discoloration  1/39 (2.56%)  1
Reproductive system and breast disorders   
Irregular menstruation  1/39 (2.56%)  2
Pelvic pain  1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis  1/39 (2.56%)  1
Atelectasis  1/39 (2.56%)  1
Cough  8/39 (20.51%)  8
Dyspnea  7/39 (17.95%)  9
Epistaxis  1/39 (2.56%)  1
Hoarseness  2/39 (5.13%)  2
Nasal congestion  3/39 (7.69%)  3
Pleural effusion  1/39 (2.56%)  1
Pneumonitis  1/39 (2.56%)  1
Pulmonary edema  1/39 (2.56%)  1
Sore throat  3/39 (7.69%)  3
Wheezing  3/39 (7.69%)  3
Skin and subcutaneous tissue disorders   
Alopecia  3/39 (7.69%)  5
Scalp pain  1/39 (2.56%)  1
Vascular disorders   
Hot flashes  2/39 (5.13%)  2
Hypertension  1/39 (2.56%)  1
Thromboembolic event  9/39 (23.08%)  9
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: Dr. Mark Zalupski, M.D.
Organization: University of Michigan Comprehensive Cancer Center
Phone: 734-615-3969
EMail: zalupski@umich.edu
Publications:
Colucci et al., 2002, Louvet et al., 2005, Berlin et al., 2002, Cunningham et al., 2009, Heinemann et al., 2008, Valle et al., 2010
Layout table for additonal information
Responsible Party: University of Michigan Rogel Cancer Center
ClinicalTrials.gov Identifier: NCT01661114     History of Changes
Other Study ID Numbers: UMCC 2011.036
HUM 49518 ( Other Identifier: University of Michigan IRBMED )
First Submitted: July 24, 2012
First Posted: August 9, 2012
Results First Submitted: January 5, 2016
Results First Posted: February 4, 2016
Last Update Posted: October 19, 2016