Trial Outcomes & Findings for A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers (NCT NCT01661114)
NCT ID: NCT01661114
Last Updated: 2016-10-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
28 days
Results posted on
2016-10-19
Participant Flow
Participant milestones
| Measure |
Gemcitabine, 5-FU and Cisplatin
4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Trial of Gemcitabine, Infusional 5-Fluorouracil and Cisplatin for Advanced Pancreatic and Biliary Cancers
Baseline characteristics by cohort
| Measure |
Gemcitabine, 5-FU and Cisplatin
n=39 Participants
4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
|
|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysPopulation: Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.
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.
Outcome measures
| Measure |
Gemcitabine, 5-FU and Cisplatin
n=39 Participants
4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
|
|---|---|
|
The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment
Untreated
|
40 percentage of patients
Interval 21.1 to 61.3
|
|
The Percentage of Untreated and Previously Treated Patients That Had a Partial Response to Treatment
Received Previous Treatment
|
7.1 percentage of patients
Interval 1.8 to 33.9
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Patients with metastatic adenocarcinoma of the pancreas or biliary tract, previously untreated or having received one cytotoxic regimen for advanced disease.
To assess the overall survival following treatment with gemcitabine, 5-FU and cisplatin.
Outcome measures
| Measure |
Gemcitabine, 5-FU and Cisplatin
n=39 Participants
4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
|
|---|---|
|
Median Overall Survival of Previously Treated and Previously Untreated Patients
Previously Untreated
|
10.3 Months
Interval 8.0 to 19.4
|
|
Median Overall Survival of Previously Treated and Previously Untreated Patients
Previously Treated
|
4.9 Months
Interval 3.6 to 11.9
|
Adverse Events
Gemcitabine, 5-FU and Cisplatin
Serious events: 10 serious events
Other events: 39 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine, 5-FU and Cisplatin
n=39 participants at risk
4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
|
|---|---|
|
Gastrointestinal disorders
Anal Ulcer
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal obstruction
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Number of events 2
|
|
Gastrointestinal disorders
Vomiting
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Chills
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Fatigue
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Fever
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Infections and infestations - Other
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Joint infection
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Upper respiratory infection
|
2.6%
1/39 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.6%
1/39 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Syncope
|
5.1%
2/39 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/39 • Number of events 1
|
Other adverse events
| Measure |
Gemcitabine, 5-FU and Cisplatin
n=39 participants at risk
4 cycles - Gemcitabine, 5-FU and Cisplatin (2 months)-Continue treatment until progression of disease or intolerable toxicity
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
92.3%
36/39 • Number of events 49
|
|
Cardiac disorders
Palpitations
|
2.6%
1/39 • Number of events 1
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.6%
1/39 • Number of events 2
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other
|
2.6%
1/39 • Number of events 1
|
|
Ear and labyrinth disorders
Hearing impaired
|
2.6%
1/39 • Number of events 1
|
|
Eye disorders
Blurred vision
|
7.7%
3/39 • Number of events 3
|
|
Eye disorders
Eye pain
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
20.5%
8/39 • Number of events 9
|
|
Gastrointestinal disorders
Anal ulcer
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Bloating
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Cheilitis
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
30.8%
12/39 • Number of events 14
|
|
Gastrointestinal disorders
Diarrhea
|
33.3%
13/39 • Number of events 18
|
|
Gastrointestinal disorders
Dry mouth
|
7.7%
3/39 • Number of events 3
|
|
Gastrointestinal disorders
Duodenal obstruction
|
5.1%
2/39 • Number of events 2
|
|
Gastrointestinal disorders
Duodenal ulcer
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Dysphagia
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Enterocolitis
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
3/39 • Number of events 3
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Mucositis oral
|
15.4%
6/39 • Number of events 6
|
|
Gastrointestinal disorders
Nausea
|
61.5%
24/39 • Number of events 38
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Oral pain
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Pancreatitis
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
38.5%
15/39 • Number of events 23
|
|
General disorders
Chills
|
7.7%
3/39 • Number of events 4
|
|
General disorders
Edema face
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Edema limbs
|
10.3%
4/39 • Number of events 4
|
|
General disorders
Facial pain
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Fatigue
|
66.7%
26/39 • Number of events 36
|
|
General disorders
Fever
|
23.1%
9/39 • Number of events 10
|
|
General disorders
Flu like symptoms
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Localized edema
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Neck edema
|
7.7%
3/39 • Number of events 3
|
|
General disorders
Non-cardiac chest pain
|
7.7%
3/39 • Number of events 4
|
|
General disorders
Pain
|
10.3%
4/39 • Number of events 4
|
|
Infections and infestations
Appendicitis
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Eye infection
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Infections and infestations - Other
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Joint infection
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Mucosal infection
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Papulopustular rash
|
2.6%
1/39 • Number of events 1
|
|
Infections and infestations
Tooth infection
|
5.1%
2/39 • Number of events 3
|
|
Infections and infestations
Upper respiratory infection
|
10.3%
4/39 • Number of events 5
|
|
Infections and infestations
Urinary tract infection
|
2.6%
1/39 • Number of events 1
|
|
Injury, poisoning and procedural complications
Hip fracture
|
2.6%
1/39 • Number of events 1
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
2.6%
1/39 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
17.9%
7/39 • Number of events 12
|
|
Investigations
Alkaline phosphatase increased
|
25.6%
10/39 • Number of events 12
|
|
Investigations
Aspartate aminotransferase increased
|
20.5%
8/39 • Number of events 11
|
|
Investigations
Blood bilirubin increased
|
15.4%
6/39 • Number of events 10
|
|
Investigations
Creatinine increased
|
12.8%
5/39 • Number of events 6
|
|
Investigations
Lipase increased
|
2.6%
1/39 • Number of events 1
|
|
Investigations
Lymphocyte count decreased
|
74.4%
29/39 • Number of events 44
|
|
Investigations
Neutrophil count decreased
|
69.2%
27/39 • Number of events 50
|
|
Investigations
Platelet count decreased
|
74.4%
29/39 • Number of events 53
|
|
Investigations
Serum amylase increased
|
2.6%
1/39 • Number of events 1
|
|
Investigations
Weight gain
|
5.1%
2/39 • Number of events 3
|
|
Investigations
Weight loss
|
28.2%
11/39 • Number of events 14
|
|
Investigations
White blood cell decreased
|
79.5%
31/39 • Number of events 65
|
|
Metabolism and nutrition disorders
Anorexia
|
33.3%
13/39 • Number of events 14
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
2.6%
1/39 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
53.8%
21/39 • Number of events 29
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.3%
4/39 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.2%
11/39 • Number of events 13
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
33.3%
13/39 • Number of events 18
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
2.6%
1/39 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.9%
7/39 • Number of events 8
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
10.3%
4/39 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyponatremia
|
38.5%
15/39 • Number of events 19
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.6%
1/39 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.8%
5/39 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.6%
1/39 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
7.7%
3/39 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.8%
5/39 • Number of events 6
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
17.9%
7/39 • Number of events 7
|
|
Nervous system disorders
Dysgeusia
|
5.1%
2/39 • Number of events 2
|
|
Nervous system disorders
Headache
|
15.4%
6/39 • Number of events 6
|
|
Nervous system disorders
Intracranial hemorrhage
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Memory impairment
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
23.1%
9/39 • Number of events 9
|
|
Nervous system disorders
Syncope
|
7.7%
3/39 • Number of events 3
|
|
Nervous system disorders
Tremor
|
2.6%
1/39 • Number of events 1
|
|
Psychiatric disorders
Agitation
|
2.6%
1/39 • Number of events 1
|
|
Psychiatric disorders
Anxiety
|
17.9%
7/39 • Number of events 9
|
|
Psychiatric disorders
Depression
|
10.3%
4/39 • Number of events 4
|
|
Renal and urinary disorders
Urinary retention
|
5.1%
2/39 • Number of events 2
|
|
Renal and urinary disorders
Urine discoloration
|
2.6%
1/39 • Number of events 1
|
|
Reproductive system and breast disorders
Irregular menstruation
|
2.6%
1/39 • Number of events 2
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
20.5%
8/39 • Number of events 8
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
17.9%
7/39 • Number of events 9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.1%
2/39 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
3/39 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
3/39 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.7%
3/39 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
3/39 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
Hot flashes
|
5.1%
2/39 • Number of events 2
|
|
Vascular disorders
Hypertension
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
Thromboembolic event
|
23.1%
9/39 • Number of events 9
|
Additional Information
Dr. Mark Zalupski, M.D.
University of Michigan Comprehensive Cancer Center
Phone: 734-615-3969
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place