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Trial record 62 of 63 for:    "Bile Duct Disease" | "Anti-Infective Agents"

S0202 Gemcitabine and Capecitabine for Unresectable Locally Advanced Metastatic Gallbladder Cancer or Cholangiocarcinoma

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ClinicalTrials.gov Identifier: NCT00033540
Recruitment Status : Completed
First Posted : January 27, 2003
Results First Posted : August 28, 2012
Last Update Posted : September 12, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Southwest Oncology Group

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: capecitabine
Drug: gemcitabine hydrochloride
Enrollment 57
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Capecitabine + Gemcitabine
Hide Arm/Group Description Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Period Title: Overall Study
Started 57
Eligible 54
Eligible and Began Protocol Therapy 52 [1]
Completed 0
Not Completed 57
Reason Not Completed
Adverse Event             14
Death             1
Progression             26
Withdrawal by Subject             6
Not specified             5
Ineligible             3
Never received treatment             2
[1]
One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
Arm/Group Title Capecitabine + Gemcitabine
Hide Arm/Group Description Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Overall Number of Baseline Participants 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants
58.8
(29.5 to 85.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Female
26
  50.0%
Male
26
  50.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
Hispanic or Latino
4
   7.7%
Not Hispanic or Latino
47
  90.4%
Unknown or Not Reported
1
   1.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants
American Indian or Alaska Native
1
   1.9%
Asian
6
  11.5%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  11.5%
White
37
  71.2%
More than one race
0
   0.0%
Unknown or Not Reported
2
   3.8%
1.Primary Outcome
Title Response
Hide Description Complete Response (CR) is complete disappearance of all measurable and non-measurable disease. No new lesions, no disease related symptoms. Normalization of markers and other abnormal lab values. Partial Response (PR) is greater than or equal to 30% decrease under baseline of the sum of longest diameters of all target measurable lesions. No unequivocal progression of non-measurable disease. No new lesions. Confirmation of CR or PR means a repeat scan at least 4 weeks apart documented before progression or symptomatic deterioration. Progression is 20% increase in sum of longest diameters of target measurable lesions over smallest sum observed and/or unequivocal progression of non-measurable disease and/or appearance of new lesion/site or death due to disease without prior documentation of progression and without symptomatic deterioration. Symptomatic deterioration is global deterioration of health status requiring discontinuation of treatment without objective evidence of progression.
Time Frame Patients assessed at least every six weeks while on protocol treatment
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in assessing response estimates.
Arm/Group Title Capecitabine + Gemcitabine
Hide Arm/Group Description:
Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Overall Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: participants
Confirmed Partial Response 7
Unconfirmed Partial Response 6
Stable Disease 12
Progression 15
Symptomatic Deterioration 3
Early Death 1
Inadequate Assessment 8
2.Secondary Outcome
Title Overall Survival
Hide Description Measured from time of registration to death, or last contact date
Time Frame All patients will be followed until death or three years after registration, whichever is first.
Hide Outcome Measure Data
Hide Analysis Population Description
All eligible patients who started treatment were included in assessing response estimates.
Arm/Group Title Capecitabine + Gemcitabine
Hide Arm/Group Description:
Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Overall Number of Participants Analyzed 52
Median (95% Confidence Interval)
Unit of Measure: months
7
(5 to 8)
3.Secondary Outcome
Title Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drug
Hide Description Adverse Events (AEs) are reported by the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included. For each patient, worst grade of each event type is reported.
Time Frame Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received any treatment and were assessed for toxicity were included in the adverse event summaries. Any CTCAE 3.0 event of Grade 3 (severe), Grade 4 (life threatening) or Grade 5 (fatal) which were deemed to be related to protocol treatment are included.
Arm/Group Title Gemcitabine and Capecitabine
Hide Arm/Group Description:
Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Overall Number of Participants Analyzed 51
Measure Type: Number
Unit of Measure: Participants
ALT, SGPT (serum glutamic pyruvic transaminase) 1
AST,SGOT (serum glutamic oxaloacetic transaminase) 5
Albumin, serum-low (hypoalbuminemia) 1
Alkaline phosphatase 5
Anorexia 2
Ascites (non-malignant) 1
Bilirubin (hyperbilirubinemia) 4
Constipation 1
Creatinine 1
Dehydration 3
Diarrhea 1
Dysphagia (difficulty swallowing) 1
Fatigue (asthenia, lethargy, malaise) 8
Hemoglobin 6
Hemolysis 1
Hemorrhage, GI - Esophagus 1
Infection w/Grade 3-4 neutrophils - Upper airway 1
Infection with normal ANC or Grade 1-2 neutrophils 1
Leukocytes (total WBC) 9
Mucositis/stomatitis (clinical exam) - Oral cavity 1
Mucositis/stomatitis (function/symp)-Oral cavity 1
Muscle weakness (not due to neuropathy) 1
Nausea 3
Neutrophils/granulocytes (ANC/AGC) 16
Pain - Abdomen NOS 2
Pain - Joint 1
Pain - Muscle 1
Pain - Tumor pain 1
Platelets 12
Potassium, serum-low (hypokalemia) 2
Rash: hand-foot skin reaction 4
Supraventricular nodal arrhythmia 1
Thrombosis/thrombus/embolism 1
Vomiting 2
4.Secondary Outcome
Title Accrual of Patients With This Disease Site
Hide Description Only eligible patients who received treatment were evaluable for response and survival outcomes.
Time Frame 1-20 months
Hide Outcome Measure Data
Hide Analysis Population Description
Patients with advanced disease accrued between September 2003 to April 2005
Arm/Group Title Capecitabine + Gemcitabine
Hide Arm/Group Description:
Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Overall Number of Participants Analyzed 57
Measure Type: Number
Unit of Measure: participants
Eligible 54
Eligible and Analyzable 52
5.Secondary Outcome
Title Median Survival Time for Participants With Relevant Biologic Markers
Hide Description To evaluate in a preliminary fashion relevant prognostic markers in gallbladder and cholangiocarcinoma which may have prognostic implications as predictors of survival. Overall survival measured from time of registration to death, or last contact date.
Time Frame All patients will be followed until death or three years after registration, whichever is first.
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible patients who received genotyping were included in this analysis.
Arm/Group Title Capecitabine + Gemcitabine
Hide Arm/Group Description:
Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
Overall Number of Participants Analyzed 22
Median (95% Confidence Interval)
Unit of Measure: months
TS 3' +/+ (N=14)
7
(4 to 13)
TS 3' +/- (N=6)
7
(2 to 7)
TS 3' -/- (N=2)
9 [1] 
(2 to NA)
TS 5' Low functional significance (N=16)
9
(4 to 12)
TS 5' Intermediate functional significance (N=16)
7
(2 to 7)
MTHFR C677T - C/C (N=11)
6
(4 to 9)
MTHFR C677T - C/T (N=11)
7
(2 to 13)
MTHFR A1298C - A/A (N=11)
7
(4 to 12)
MTHFR A1298C - A/C (N=8)
4
(2 to 6)
MTHFR A1298C - C/C (N=3)
9
(5 to 9)
RRMI G/A - G/G (N=9)
7
(4 to 7)
RRMI G/A - G/A (N=10)
9
(2 to 12)
RRMI G/A - A/A (N=3)
5
(4 to 5)
CDA A79C - A/A (N=8)
4
(2 to 5)
CDA A79C - A/C (N=12)
7
(5 to 9)
CDA A79C - C/C (N=1)
NA [1] 
(NA to NA)
[1]
insufficient number of participants
Time Frame Patients were assessed for adverse events 3 weeks after starting treatment. Assessments for adverse events continued every 3 weeks for the duration of protocol treatment.
Adverse Event Reporting Description One patient went off study prior to any toxicity assessments and is not evaluable for toxicities.
 
Arm/Group Title Gemcitabine and Capecitabine
Hide Arm/Group Description Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
All-Cause Mortality
Gemcitabine and Capecitabine
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gemcitabine and Capecitabine
Affected / at Risk (%)
Total   7/51 (13.73%) 
General disorders   
Constitutional Symptoms-Other (Specify)  1 [1]  2/51 (3.92%) 
Hepatobiliary disorders   
Hepatobiliary/Pancreas-Biliary obstruction  1  1/51 (1.96%) 
Infections and infestations   
Inf w/normal ANC or Gr 1-2 neutrophils - Blood  1  1/51 (1.96%) 
Investigations   
Bilirubin (hyperbilirubinemia)  1  1/51 (1.96%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Death - Disease progression NOS  1  3/51 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
[1]
Death - progressive disease
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Gemcitabine and Capecitabine
Affected / at Risk (%)
Total   51/51 (100.00%) 
Blood and lymphatic system disorders   
Hemoglobin  1  42/51 (82.35%) 
Eye disorders   
Ocular surface disease  1  3/51 (5.88%) 
Gastrointestinal disorders   
Ascites (non-malignant)  1  4/51 (7.84%) 
Constipation  1  21/51 (41.18%) 
Diarrhea  1  17/51 (33.33%) 
Heartburn/dyspepsia  1  4/51 (7.84%) 
Mucositis/stomatitis (clinical exam) - Oral cavity  1  11/51 (21.57%) 
Mucositis/stomatitis (functional/symp) - Oral cav  1  6/51 (11.76%) 
Nausea  1  32/51 (62.75%) 
Pain - Abdomen NOS  1  18/51 (35.29%) 
Vomiting  1  19/51 (37.25%) 
General disorders   
Edema: limb  1  12/51 (23.53%) 
Fatigue (asthenia, lethargy, malaise)  1  44/51 (86.27%) 
Fever in absence of neutropenia, ANC lt1.0x10e9/L  1  15/51 (29.41%) 
Injection site reaction/extravasation changes  1  3/51 (5.88%) 
Pain-Other (Specify)  1  4/51 (7.84%) 
Rigors/chills  1  10/51 (19.61%) 
Hepatobiliary disorders   
Liver dysfunction/failure (clinical)  1  7/51 (13.73%) 
Infections and infestations   
Inf w/normal ANC or Gr 1-2 neutrophils - Bladder  1  4/51 (7.84%) 
Inf w/normal ANC or Gr 1-2 neutrophils - Skin  1  3/51 (5.88%) 
Investigations   
ALT, SGPT (serum glutamic pyruvic transaminase)  1  12/51 (23.53%) 
AST, SGOT  1  39/51 (76.47%) 
Alkaline phosphatase  1  36/51 (70.59%) 
Bilirubin (hyperbilirubinemia)  1  13/51 (25.49%) 
Creatinine  1  3/51 (5.88%) 
GGT (gamma-glutamyl transpeptidase)  1  3/51 (5.88%) 
Leukocytes (total WBC)  1  29/51 (56.86%) 
Neutrophils/granulocytes (ANC/AGC)  1  30/51 (58.82%) 
Platelets  1  29/51 (56.86%) 
Weight loss  1  8/51 (15.69%) 
Metabolism and nutrition disorders   
Albumin, serum-low (hypoalbuminemia)  1  13/51 (25.49%) 
Anorexia  1  14/51 (27.45%) 
Calcium, serum-low (hypocalcemia)  1  7/51 (13.73%) 
Dehydration  1  4/51 (7.84%) 
Glucose, serum-high (hyperglycemia)  1  18/51 (35.29%) 
Potassium, serum-high (hyperkalemia)  1  3/51 (5.88%) 
Potassium, serum-low (hypokalemia)  1  5/51 (9.80%) 
Sodium, serum-low (hyponatremia)  1  9/51 (17.65%) 
Musculoskeletal and connective tissue disorders   
Muscle weakness, not d/t neuropathy - Extrem-lower  1  3/51 (5.88%) 
Muscle weakness, not d/t neuropathy - body/general  1  3/51 (5.88%) 
Pain - Back  1  8/51 (15.69%) 
Pain - Extremity-limb  1  3/51 (5.88%) 
Pain - Joint  1  4/51 (7.84%) 
Pain - Muscle  1  4/51 (7.84%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Pain - Tumor pain  1  14/51 (27.45%) 
Nervous system disorders   
Neuropathy: sensory  1  5/51 (9.80%) 
Pain - Head/headache  1  7/51 (13.73%) 
Taste alteration (dysgeusia)  1  4/51 (7.84%) 
Psychiatric disorders   
Insomnia  1  5/51 (9.80%) 
Mood alteration - anxiety  1  4/51 (7.84%) 
Mood alteration - depression  1  3/51 (5.88%) 
Respiratory, thoracic and mediastinal disorders   
Cough  1  5/51 (9.80%) 
Dyspnea (shortness of breath)  1  13/51 (25.49%) 
Pleural effusion (non-malignant)  1  3/51 (5.88%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  3/51 (5.88%) 
Hair loss/Alopecia (scalp or body)  1  12/51 (23.53%) 
Nail changes  1  6/51 (11.76%) 
Pruritus/itching  1  10/51 (19.61%) 
Rash/desquamation  1  14/51 (27.45%) 
Rash: hand-foot skin reaction  1  11/51 (21.57%) 
Vascular disorders   
Thrombosis/thrombus/embolism  1  3/51 (5.88%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Statistician
Organization: Southwest Oncology Group (SWOG) Statistical Center
Phone: 206-667-4623
Publications of Results:
Iqbal S, et al.: SWOG S0202: a phase II trial of gemcitabine and capecitabine in patients (pts) with unresectable or metastatic gallbladder cancer or cholangiocarcinoma. [Abstract] J Clin Oncol 24 (Suppl 18): A-4134, 2006.
Layout table for additonal information
Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00033540     History of Changes
Other Study ID Numbers: CDR0000069299
S0202 ( Other Identifier: SWOG )
U10CA032102 ( U.S. NIH Grant/Contract )
First Submitted: April 9, 2002
First Posted: January 27, 2003
Results First Submitted: June 14, 2012
Results First Posted: August 28, 2012
Last Update Posted: September 12, 2017