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Trial record 50 of 63 for:    "Bile Duct Disease" | "Anti-Infective Agents"

Gemcitabine, Oxaliplatin, Tarceva &/or Cisplatin in HCC & Biliary Tree Cancers (Gem-ox)

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ClinicalTrials.gov Identifier: NCT00832637
Recruitment Status : Terminated (Low accrual)
First Posted : January 30, 2009
Results First Posted : July 14, 2015
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
New Mexico Cancer Care Alliance

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Hepatocellular Carcinoma
Cholangiocellular Carcinoma
Cholangiocarcinoma of the Extrahepatic Bile Duct
Bile Duct Cancer
Periampullary Adenocarcinoma
Gallbladder Cancer
Extrahepatic Bile Duct Cancer
Interventions Drug: Cisplatin
Drug: Erlotinib
Drug: Gemcitabine
Enrollment 33
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gemcitabine, Cisplatin, Erlotinib
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Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.

Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.

Erlotinib: 100 mg orally daily.

Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Period Title: Overall Study
Started 33
Completed 33
Not Completed 0
Arm/Group Title Gemcitabine, Cisplatin, Erlotinib
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Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.

Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.

Erlotinib: 100 mg orally daily.

Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Overall Number of Baseline Participants 33
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 33 participants
59
(42 to 77)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 33 participants
Female
8
  24.2%
Male
25
  75.8%
1.Primary Outcome
Title Tumor Control Rate
Hide Description

Rate of tumor control is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) + stable disease (SD) at 24 weeks following treatment.

Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time Frame 24 weeks
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Cisplatin, Erlotinib
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Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.

Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.

Erlotinib: 100 mg orally daily.

Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: percentage of evaluable participants
Complete response (CR) 0
Partial response (PR) 7.1
Stable disease (SD) 53.6
CR + PR + SD 60.7
2.Secondary Outcome
Title Overall Response Rate
Hide Description

Overall response rate is defined as the percentage of patients achieving a complete response (CR) + partial response (PR) at 24 weeks following treatment.

Response is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient decrease in the sum of the longest diameter of target lesions to qualify for PR nor sufficient increase in the sum of the longest diameter of target lesions to qualify for Progressive Disease; Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Cisplatin, Erlotinib
Hide Arm/Group Description:

Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.

Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.

Erlotinib: 100 mg orally daily.

Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Overall Number of Participants Analyzed 28
Measure Type: Number
Unit of Measure: percentage of evaluable participants
Complete response (CR) 0
Partial response (PR) 7.1
CR + PR 7.1
3.Secondary Outcome
Title Time to Tumor Progression (TTP)
Hide Description The time from treatment initiation to disease progression. Progression is evaluated according to Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.0). Target lesions are assessed by computerized tomography (CT) or magnetic resonance imaging (MRI): Progressive Disease (PD), 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Cisplatin, Erlotinib
Hide Arm/Group Description:

Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.

Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.

Erlotinib: 100 mg orally daily.

Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: weeks
22
(18 to 78)
4.Secondary Outcome
Title Median Survival Time (MST)
Hide Description Survival is defined as the time from treatment initiation to death by any cause
Time Frame 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Cisplatin, Erlotinib
Hide Arm/Group Description:

Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.

Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.

Erlotinib: 100 mg orally daily.

Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Overall Number of Participants Analyzed 33
Median (95% Confidence Interval)
Unit of Measure: weeks
28
(21 to 53)
5.Secondary Outcome
Title Toxicity
Hide Description Toxicity will be evaluated per National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0. Frequency and severity of adverse events will be tabulated using counts of frequently occurring, serious and severe events of interest (i.e. Grade 3 and Grade 4 adverse events).
Time Frame Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition. An average of 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Gemcitabine, Cisplatin, Erlotinib
Hide Arm/Group Description:

Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.

Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.

Erlotinib: 100 mg orally daily.

Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

Overall Number of Participants Analyzed 33
Measure Type: Number
Unit of Measure: participants
Anemia 2
Neutropenia 7
Neutropenic Fever 2
Thrombocytopenia 6
Diarrhea 4
Abdominal Pain 2
Renal Failure 1
Dermatitis (acneiform) 3
Peripheral neuropathy 1
Metabolic syndrome 2
Cerebral hemorrhage 1
Time Frame Patients are followed for at least one month following end of on-study treatment. All patients who discontinue the trial secondary to an adverse event are followed until resolution, stabilization or return to a baseline condition, an average of 24 weeks.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gemcitabine, Cisplatin, Erlotinib
Hide Arm/Group Description

Cisplatin at a dose of 40 mg/m2 q 2 weeks along with gemcitabine, 1000mg/m2, and erlotinib 100 mg daily PO.

Cisplatin: Cisplatin 40 mg/ m2 on day 1 and day 15 in patients treated with Gem + Cis, with Cisplatin to be given following Gemcitabine. Cisplatin administration should be given along with hydration with NS at 250 mL/ hour for at least 4 hours pre-and during Cisplatin administration. Additionally, Cisplatin administration should be preceded by osmotic diuresis with Mannitol 25%, 12.5 grams.

Erlotinib: 100 mg orally daily.

Gemcitabine: 1000 mg/m2 on Days 1, 15 every 28 days. The clinical formulation is supplied in a sterile form for intravenous use only. Vials of gemcitabine contain either 200 mg or 1 g of gemcitabine HCl (expressed as free base) formulated with mannitol (200 mg or 1 g, respectively) and sodium acetate (12.5 mg or 62.5 mg, respectively) as a sterile lyophilized powder. Hydrochloric acid and/or sodium hydroxide may have been added for pH adjustment.

All-Cause Mortality
Gemcitabine, Cisplatin, Erlotinib
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine, Cisplatin, Erlotinib
Affected / at Risk (%) # Events
Total   17/33 (51.52%)    
Blood and lymphatic system disorders   
Hemolysis (Red blood cell destruction) * 1  1/33 (3.03%)  1
Gastrointestinal disorders   
Anorexia (Loss of appetite) * 1  1/33 (3.03%)  1
Ascites * 1  2/33 (6.06%)  2
Diarrhea * 1  1/33 (3.03%)  1
Gastritis (Stomach lining inflammation) * 1  1/33 (3.03%)  1
Upper gastrointestinal hemorrhage * 1  1/33 (3.03%)  1
General disorders   
Fatigue * 1  1/33 (3.03%)  1
Fever * 1  2/33 (6.06%)  3
Abdominal pain * 1  2/33 (6.06%)  2
Chest pain * 1  1/33 (3.03%)  1
Death * 1  4/33 (12.12%)  4
Immune system disorders   
Hypersensitivity reaction * 1  1/33 (3.03%)  1
Infections and infestations   
Device related infection * 1  1/33 (3.03%)  1
Febrile neutropenia * 1  1/33 (3.03%)  1
Pneumonia * 1  2/33 (6.06%)  2
Urinary tract infection * 1  1/33 (3.03%)  1
Investigations   
Hypokalemia (Low potassium level in blood) * 1  1/33 (3.03%)  1
Nervous system disorders   
Extrapyramidal disorder * 1  1/33 (3.03%)  1
Renal and urinary disorders   
Renal failure * 1  1/33 (3.03%)  1
*
Indicates events were collected by non-systematic assessment
1
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, Cisplatin, Erlotinib
Affected / at Risk (%) # Events
Total   32/33 (96.97%)    
Blood and lymphatic system disorders   
Hemoglobin decreased * 1  5/33 (15.15%)  12
Hemolysis (Red blood cell destruction) * 1  7/33 (21.21%)  7
Leukocytes decreased * 1  7/33 (21.21%)  10
Neutrophils decreased * 1  7/33 (21.21%)  18
Platelet count decreased * 1  14/33 (42.42%)  44
Cardiac disorders   
Atrial tachycardia * 1  2/33 (6.06%)  2
Gastrointestinal disorders   
Abdominal distention * 1  3/33 (9.09%)  3
Anorexia (Loss of appetite) * 1  10/33 (30.30%)  10
Ascites (Accumulation of fluid in the abdomen) * 1  4/33 (12.12%)  4
Constipation * 1  8/33 (24.24%)  9
Dehydration * 1  6/33 (18.18%)  7
Diarrhea * 1  18/33 (54.55%)  22
Gastritis (Stomach lining inflammation) * 1  2/33 (6.06%)  2
Nausea * 1  16/33 (48.48%)  19
Vomiting * 1  11/33 (33.33%)  14
General disorders   
Rhinitis (Runny nose) * 1  5/33 (15.15%)  12
Fatigue * 1  22/33 (66.67%)  27
Fever * 1  8/33 (24.24%)  9
Weight Loss * 1  5/33 (15.15%)  6
Epistaxis (Nosebleed) * 1  3/33 (9.09%)  3
Edema: limbs * 1  3/33 (9.09%)  5
Edema: trunk/genital * 1  2/33 (6.06%)  3
Abdominal pain * 1  5/33 (15.15%)  8
Extremity - Limb pain * 1  2/33 (6.06%)  2
Neck Pain * 1  2/33 (6.06%)  2
Infections and infestations   
Febrile neutropenia * 1  3/33 (9.09%)  3
Urinary Tract Infection * 1  2/33 (6.06%)  2
Investigations   
Alkaline phosphatase increased * 1  2/33 (6.06%)  3
Aspartate aminotransferase increased * 1  2/33 (6.06%)  2
Hyperbilirubinemia (High level of bilirubin) * 1  6/33 (18.18%)  10
Hyperglycemia (High glucose level in blood) * 1  3/33 (9.09%)  4
Hypoalbuminemia (Low level of albumin in blood) * 1  4/33 (12.12%)  8
Hypocalcemia (Low calcium level in blood) * 1  3/33 (9.09%)  5
ypocalcemia (Low calcium level in blood) * 1  3/33 (9.09%)  5
Hypokalemia (Low potassium level in blood) * 1  5/33 (15.15%)  9
Hypomagnesemia (Low magnesium level in blood) * 1  3/33 (9.09%)  4
Hyponatremia (Low sodium level in blood) * 1  4/33 (12.12%)  5
Nervous system disorders   
Anxiety * 1  3/33 (9.09%)  3
Confusion * 1  4/33 (12.12%)  4
Dizziness * 1  2/33 (6.06%)  2
Headache * 1  2/33 (6.06%)  4
Insomnia * 1  7/33 (21.21%)  7
Peripheral motor neuropathy * 1  3/33 (9.09%)  3
Peripheral sensory neuropathy * 1  3/33 (9.09%)  5
Respiratory, thoracic and mediastinal disorders   
Cough * 1  2/33 (6.06%)  2
Dyspnea (Shortness of breath) * 1  2/33 (6.06%)  2
Hiccups * 1  3/33 (9.09%)  3
Skin and subcutaneous tissue disorders   
Alopecia (Hair loss) * 1  2/33 (6.06%)  3
Hand and foot syndrome * 1  2/33 (6.06%)  3
Rash * 1  6/33 (18.18%)  7
Acne * 1  9/33 (27.27%)  12
Desquamating rash * 1  9/33 (27.27%)  9
*
Indicates events were collected by non-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: Yehuda Patt, MD
Organization: University of New Mexico
Phone: 5059250405
EMail: yzpatt@salud.unm.edu
Layout table for additonal information
Responsible Party: New Mexico Cancer Care Alliance
ClinicalTrials.gov Identifier: NCT00832637     History of Changes
Other Study ID Numbers: INST OX-05-024
NCI-2011-02729 ( Registry Identifier: NCI Clinical Trial Reporting Program )
B9E-US-X467 ( Other Grant/Funding Number: Eli Lilly )
First Submitted: January 13, 2009
First Posted: January 30, 2009
Results First Submitted: June 15, 2015
Results First Posted: July 14, 2015
Last Update Posted: June 29, 2018