Trial Outcomes & Findings for Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy (NCT NCT00919061)
NCT ID: NCT00919061
Last Updated: 2016-02-03
Results Overview
Progression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
39 participants
Primary outcome timeframe
6 months
Results posted on
2016-02-03
Participant Flow
Participant milestones
| Measure |
Gemcitabine and Cisplatin Plus Sorafenib
This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Gemcitabine and Cisplatin Plus Sorafenib
This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy
Baseline characteristics by cohort
| Measure |
Gemcitabine and Cisplatin Plus Sorafenib
n=39 Participants
This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsProgression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.
Outcome measures
| Measure |
Gemcitabine and Cisplatin Plus Sorafenib
n=37 Participants
This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle.
|
|---|---|
|
Progression-Free Survival
|
51 percentage of participants
Interval 34.0 to 66.0
|
PRIMARY outcome
Timeframe: 6 mosProgression free survival will be calculated from study entry to documented disease progression, death from any cause, or drop out due to toxicity, whichever occurs first.
Outcome measures
| Measure |
Gemcitabine and Cisplatin Plus Sorafenib
n=37 Participants
This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle.
|
|---|---|
|
Median PFS
Progression Free Survival
|
6.5 months
Interval 3.5 to 8.3
|
|
Median PFS
Overall Survival
|
14.4 months
Interval 11.6 to 19.2
|
Adverse Events
Gemcitabine and Cisplatin Plus Sorafenib
Serious events: 24 serious events
Other events: 37 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gemcitabine and Cisplatin Plus Sorafenib
n=39 participants at risk
This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle.
|
|---|---|
|
Gastrointestinal disorders
Ascites
|
5.1%
2/39 • Number of events 2
|
|
Investigations
Bilirubin (hyperbilirubinemia)
|
2.6%
1/39 • Number of events 2
|
|
Investigations
Blood disorder
|
2.6%
1/39 • Number of events 1
|
|
Investigations
Cardiac troponin I increased
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Colitis, infectious
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Death-Disease Progression
|
7.7%
3/39 • Number of events 3
|
|
Metabolism and nutrition disorders
Dehydration
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
5.1%
2/39 • Number of events 2
|
|
Gastrointestinal disorders
Dry mouth/salivary gland (xerostomia)
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
2.6%
1/39 • Number of events 1
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Fever
|
12.8%
5/39 • Number of events 6
|
|
Reproductive system and breast disorders
Fistula, GU - Vagina
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal, other
|
5.1%
2/39 • Number of events 3
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.6%
1/39 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
5.1%
2/39 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemorrhage/Bleeding, other
|
2.6%
1/39 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs (hiccups, singultus)
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
Hypertension
|
5.1%
2/39 • Number of events 2
|
|
Vascular disorders
Hypotension
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Fecal incontinence
|
2.6%
1/39 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Skin infection
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Infection
|
10.3%
4/39 • Number of events 4
|
|
Gastrointestinal disorders
Nausea
|
7.7%
3/39 • Number of events 3
|
|
Investigations
Neutrophil count decreased
|
5.1%
2/39 • Number of events 2
|
|
Hepatobiliary disorders
Gallbladder obstruction
|
2.6%
1/39 • Number of events 1
|
|
Renal and urinary disorders
Ureteric obstruction
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
17.9%
7/39 • Number of events 9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Chest pain
|
2.6%
1/39 • Number of events 1
|
|
Nervous system disorders
Headache
|
5.1%
2/39 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Pain-Other
|
7.7%
3/39 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme
|
2.6%
1/39 • Number of events 1
|
|
Investigations
Platelet count decrease
|
7.7%
3/39 • Number of events 3
|
|
Renal and urinary disorders
Renal failure
|
2.6%
1/39 • Number of events 1
|
|
Renal and urinary disorders
Urogenital disorder
|
2.6%
1/39 • Number of events 1
|
|
General disorders
Chills
|
2.6%
1/39 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.6%
1/39 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
20.5%
8/39 • Number of events 9
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
2.6%
1/39 • Number of events 1
|
|
Eye disorders
Vision-blurred vision
|
2.6%
1/39 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
12.8%
5/39 • Number of events 5
|
Other adverse events
| Measure |
Gemcitabine and Cisplatin Plus Sorafenib
n=39 participants at risk
This is a non-randomized, open label, single institution, phase II study of gemcitabine and cisplatin plus sorafenib for the treatment of patients with advanced or biliary tract carcinomas naïve to systemic therapy.
Gemcitabine and Cisplatin plus Sorafenib: Patients will receive treatment under the following schedule:
Gemcitabine: 800 mg/m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Cisplatin: 20 mg /m2 over 30 minutes IV, weekly for 2 weeks, followed by a week off treatment.
Sorafenib: 400 mg PO once a day continuously. Three weeks of treatment correspond to one cycle.
|
|---|---|
|
Investigations
Alanine aminotransferase increased
|
28.2%
11/39 • Number of events 30
|
|
Investigations
Aspartate aminotransferase increased
|
20.5%
8/39 • Number of events 12
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
43.6%
17/39 • Number of events 59
|
|
Metabolism and nutrition disorders
Alkaline phosphatase increased
|
41.0%
16/39 • Number of events 69
|
|
Investigations
Serum amylase increased
|
20.5%
8/39 • Number of events 26
|
|
Metabolism and nutrition disorders
Anorexia
|
7.7%
3/39 • Number of events 3
|
|
Investigations
Blood bilirubin increased
|
15.4%
6/39 • Number of events 19
|
|
Gastrointestinal disorders
Constipation
|
12.8%
5/39 • Number of events 5
|
|
Investigations
Creatinine increased
|
5.1%
2/39 • Number of events 13
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
6/39 • Number of events 10
|
|
General disorders
Fatigue
|
43.6%
17/39 • Number of events 25
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
43.6%
17/39 • Number of events 68
|
|
Blood and lymphatic system disorders
Anemia
|
76.9%
30/39 • Number of events 366
|
|
Vascular disorders
Hypertension
|
5.1%
2/39 • Number of events 2
|
|
Infections and infestations
Infection, other
|
7.7%
3/39 • Number of events 3
|
|
Investigations
White blood cell decreased
|
41.0%
16/39 • Number of events 66
|
|
Investigations
Lipase increased
|
33.3%
13/39 • Number of events 24
|
|
Investigations
Lymphocyte count decreased
|
23.1%
9/39 • Number of events 15
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
7.7%
3/39 • Number of events 3
|
|
Gastrointestinal disorders
Nausea
|
5.1%
2/39 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
7.7%
3/39 • Number of events 5
|
|
Investigations
Neutrophil count decreased
|
38.5%
15/39 • Number of events 64
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
7.7%
3/39 • Number of events 3
|
|
General disorders
Chest pain
|
5.1%
2/39 • Number of events 2
|
|
General disorders
Pain-other
|
5.1%
2/39 • Number of events 2
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
20.5%
8/39 • Number of events 20
|
|
Investigations
Platelet count decreased
|
41.0%
16/39 • Number of events 35
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
10.3%
4/39 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.1%
2/39 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash-Hand Foot Skin Reaction
|
25.6%
10/39 • Number of events 13
|
|
Metabolism and nutrition disorders
Hyponatremia
|
10.3%
4/39 • Number of events 11
|
|
Vascular disorders
Thrombosis
|
12.8%
5/39 • Number of events 5
|
|
Ear and labyrinth disorders
Tinnitus
|
7.7%
3/39 • Number of events 3
|
Additional Information
Dr. Ghassan Abou-Alfa
Memorial Sloan Kettering Cancer Center
Phone: 646-888-4184
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place