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Trial record 49 of 63 for:    "Bile Duct Disease" | "Anti-Infective Agents"

Gemcitabine and Cisplatin Plus Sorafenib in Patients With Advanced Biliary Tract Carcinomas Naive to Systemic Therapy

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ClinicalTrials.gov Identifier: NCT00919061
Recruitment Status : Completed
First Posted : June 12, 2009
Results First Posted : February 3, 2016
Last Update Posted : February 3, 2016
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Extrahepatic Bile Duct Cancer
Gallbladder Cancer
Interventions Drug: Gemcitabine
Drug: Cisplatin
Drug: Sorafenib
Enrollment 39
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemcitabine and Cisplatin Plus Sorafenib
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 39
Completed 37
Not Completed 2
Reason Not Completed
Adverse Event             1
Withdrawal by Subject             1
Arm/Group Title Gemcitabine and Cisplatin Plus Sorafenib
Hide Arm/Group Description

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 Number of Baseline Participants 39
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
<=18 years
0
   0.0%
Between 18 and 65 years
21
  53.8%
>=65 years
18
  46.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 39 participants
Female
19
  48.7%
Male
20
  51.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 39 participants
39
1.Primary Outcome
Title Progression-Free Survival
Hide Description 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.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine and Cisplatin Plus Sorafenib
Hide Arm/Group Description:

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 Number of Participants Analyzed 37
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
51
(34 to 66)
2.Primary Outcome
Title Median PFS
Hide Description 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.
Time Frame 6 mos
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine and Cisplatin Plus Sorafenib
Hide Arm/Group Description:

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 Number of Participants Analyzed 37
Median (95% Confidence Interval)
Unit of Measure: months
Progression Free Survival
6.5
(3.5 to 8.3)
Overall Survival
14.4
(11.6 to 19.2)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemcitabine and Cisplatin Plus Sorafenib
Hide Arm/Group Description

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.

All-Cause Mortality
Gemcitabine and Cisplatin Plus Sorafenib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine and Cisplatin Plus Sorafenib
Affected / at Risk (%) # Events
Total   24/39 (61.54%)    
Blood and lymphatic system disorders   
Febrile neutropenia  2  2/39 (5.13%)  2
Anemia  2  2/39 (5.13%)  2
Hemorrhage/Bleeding, other  2  1/39 (2.56%)  1
Eye disorders   
Vision-blurred vision  2  1/39 (2.56%)  1
Gastrointestinal disorders   
Ascites  1  2/39 (5.13%)  2
Colitis, infectious  2  1/39 (2.56%)  1
Constipation  2  2/39 (5.13%)  2
Diarrhea  2  2/39 (5.13%)  2
Dry mouth/salivary gland (xerostomia)  2  1/39 (2.56%)  1
Gastrointestinal, other  2  2/39 (5.13%)  3
Fecal incontinence  2  1/39 (2.56%)  1
Nausea  2  3/39 (7.69%)  3
Abdominal pain  2  7/39 (17.95%)  9
Vomiting  2  5/39 (12.82%)  5
General disorders   
Death-Disease Progression  2  3/39 (7.69%)  3
Fatigue (asthenia, lethargy, malaise)  2  1/39 (2.56%)  1
Fever  2  5/39 (12.82%)  6
Chest pain  2  1/39 (2.56%)  1
Pain-Other  2  3/39 (7.69%)  3
Chills  2  1/39 (2.56%)  1
Hepatobiliary disorders   
Gallbladder obstruction  2  1/39 (2.56%)  1
Infections and infestations   
Infection  2  4/39 (10.26%)  4
Investigations   
Bilirubin (hyperbilirubinemia)  2  1/39 (2.56%)  2
Blood disorder  2  1/39 (2.56%)  1
Cardiac troponin I increased  2  1/39 (2.56%)  1
Neutrophil count decreased  2  2/39 (5.13%)  2
Platelet count decrease  2  3/39 (7.69%)  3
Metabolism and nutrition disorders   
Dehydration  2  1/39 (2.56%)  1
Hyperglycemia  2  1/39 (2.56%)  1
Hyponatremia  2  1/39 (2.56%)  1
Musculoskeletal and connective tissue disorders   
Back pain  2  2/39 (5.13%)  2
Neck Pain  2  1/39 (2.56%)  1
Nervous system disorders   
Headache  2  2/39 (5.13%)  2
Renal and urinary disorders   
Ureteric obstruction  2  1/39 (2.56%)  1
Renal failure  2  1/39 (2.56%)  1
Urogenital disorder  2  1/39 (2.56%)  1
Urinary frequency/urgency  2  1/39 (2.56%)  1
Reproductive system and breast disorders   
Fistula, GU - Vagina  2  1/39 (2.56%)  1
Respiratory, thoracic and mediastinal disorders   
Dyspnea (shortness of breath)  2  1/39 (2.56%)  1
Hiccoughs (hiccups, singultus)  2  1/39 (2.56%)  1
Skin and subcutaneous tissue disorders   
Skin infection  2  2/39 (5.13%)  2
Rash: erythema multiforme  2  1/39 (2.56%)  1
Vascular disorders   
Hypertension  2  2/39 (5.13%)  2
Hypotension  2  1/39 (2.56%)  1
Thrombosis  2  8/39 (20.51%)  9
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE 3.0
2
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 5%
Gemcitabine and Cisplatin Plus Sorafenib
Affected / at Risk (%) # Events
Total   37/39 (94.87%)    
Blood and lymphatic system disorders   
Anemia  1  30/39 (76.92%)  366
Ear and labyrinth disorders   
Tinnitus  1  3/39 (7.69%)  3
Gastrointestinal disorders   
Constipation  1  5/39 (12.82%)  5
Diarrhea  1  6/39 (15.38%)  10
Nausea  1  2/39 (5.13%)  2
General disorders   
Fatigue  1  17/39 (43.59%)  25
Chest pain  1  2/39 (5.13%)  2
Pain-other  1  2/39 (5.13%)  2
Infections and infestations   
Infection, other  1  3/39 (7.69%)  3
Investigations   
Alanine aminotransferase increased  1  11/39 (28.21%)  30
Aspartate aminotransferase increased  1  8/39 (20.51%)  12
Serum amylase increased  1  8/39 (20.51%)  26
Blood bilirubin increased  1  6/39 (15.38%)  19
Creatinine increased  1  2/39 (5.13%)  13
White blood cell decreased  1  16/39 (41.03%)  66
Lipase increased  1  13/39 (33.33%)  24
Lymphocyte count decreased  1  9/39 (23.08%)  15
Neutrophil count decreased  1  15/39 (38.46%)  64
Platelet count decreased  1  16/39 (41.03%)  35
Metabolism and nutrition disorders   
Hypoalbuminemia  1  17/39 (43.59%)  59
Alkaline phosphatase increased  1  16/39 (41.03%)  69
Anorexia  1  3/39 (7.69%)  3
Hyperglycemia  1  17/39 (43.59%)  68
Hypomagnesemia  1  3/39 (7.69%)  3
Hypophosphatemia  1  8/39 (20.51%)  20
Hyperkalemia  1  4/39 (10.26%)  8
Hyponatremia  1  4/39 (10.26%)  11
Musculoskeletal and connective tissue disorders   
Back Pain  1  3/39 (7.69%)  3
Nervous system disorders   
Peripheral sensory neuropathy  1  3/39 (7.69%)  5
Skin and subcutaneous tissue disorders   
Rash  1  2/39 (5.13%)  2
Rash-Hand Foot Skin Reaction  1  10/39 (25.64%)  13
Vascular disorders   
Hypertension  1  2/39 (5.13%)  2
Thrombosis  1  5/39 (12.82%)  5
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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. Ghassan Abou-Alfa
Organization: Memorial Sloan Kettering Cancer Center
Phone: 646-888-4184
EMail: abou-alg@mskcc.org
Layout table for additonal information
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00919061     History of Changes
Other Study ID Numbers: 09-029
First Submitted: June 11, 2009
First Posted: June 12, 2009
Results First Submitted: October 19, 2015
Results First Posted: February 3, 2016
Last Update Posted: February 3, 2016