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Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction

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ClinicalTrials.gov Identifier: NCT00891878
Recruitment Status : Completed
First Posted : May 1, 2009
Results First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Adenocarcinoma of the Gastroesophageal Junction
Esophageal Cancer
Interventions Drug: capecitabine
Drug: sunitinib malate
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib)
Hide Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Period Title: Overall Study
Started 6 6
Completed 6 6
Not Completed 0 0
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib) Total
Hide Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21. Total of all reporting groups
Overall Number of Baseline Participants 6 6 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 12 participants
74.5
(56 to 82)
73
(47 to 80)
73
(47 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Female
1
  16.7%
0
   0.0%
1
   8.3%
Male
5
  83.3%
6
 100.0%
11
  91.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 12 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
6
 100.0%
6
 100.0%
12
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Comparison of Progression-free Survival
Hide Description The primary analysis will be a comparison of Arm A to Arm B using a one-sided log-rank test between the 2 Kaplan-Meier curves. All patients meeting the eligibility criteria, who started treatment will be considered evaluable for the primary endpoint. If a patient is still alive 3 years after registration, no further follow-up is required. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 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 Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Overall Number of Participants Analyzed 6 6
Median (95% Confidence Interval)
Unit of Measure: Months
6.1
(0.6 to 9.2)
2.4
(0.6 to 8.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Capecitabine), Arm B (Capecitabine+Sunitinib Malate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
2.Secondary Outcome
Title Response Rate (Complete Response or Partial Response)
Hide Description A confirmed tumor response is defined to be a CR or PR noted as the objective status on 2 consecutive evaluations ≥4 weeks apart. Confirmed tumor response will be evaluated using the first 6 cycles of treatment. All patients meeting the eligibility criteria who have signed a consent form and have begun treatment will be evaluable for response. The confirmed response rates between the 2 arms will be compared using a Chi-Square or Fisher’s Exact test. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Overall Number of Participants Analyzed 6 6
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of patients
0
(0 to 46)
33
(4 to 78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm A (Capecitabine), Arm B (Capecitabine+Sunitinib Malate)
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
3.Secondary Outcome
Title Overall Survival
Hide Description Overall survival is defined as the time from randomization to death due to any cause. The distribution of overall survival will be estimated using the method of Kaplan-Meier.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Overall Number of Participants Analyzed 6 6
Median (95% Confidence Interval)
Unit of Measure: Months
6.2
(1.5 to 18.8)
5.9
(0.9 to 29.8)
4.Secondary Outcome
Title Time to Disease Progression
Hide Description Time to disease progression is defined as the time from randomization to the earliest date documentation of disease progression occurs. If a patient dies without a documentation of disease progression, the patient will be considered to have had tumor progression at the time of their death unless there is sufficient documented evidence to conclude no progression occurred prior to death. The distribution of time-to-progression will be estimated using the method of Kaplan-Meier.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Overall Number of Participants Analyzed 6 6
Median (95% Confidence Interval)
Unit of Measure: months
7.56
(1.58 to 9.20)
2.46
(2.33 to 8.44)
5.Secondary Outcome
Title Time to Treatment Failure
Hide Description Time to treatment failure is defined to be the time from the date of randomization to the date at which the patient is removed from treatment due to progression, adverse events, or refusal.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable patients
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Overall Number of Participants Analyzed 6 6
Median (95% Confidence Interval)
Unit of Measure: months
1.63
(1.51 to 10.74)
2.53
(0.69 to 8.48)
6.Secondary Outcome
Title Duration of Response
Hide Description Duration of response is defined for all evaluable patients who have achieved an objective response as the date at which the patient’s earliest best objective status is first noted to be either a CR or PR to the earliest date progression is documented.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who achieved an objective response to be either a CR or PR were included in this analysis.
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Hide Arm/Group Description:
Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion.
Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
Overall Number of Participants Analyzed 0 2
Median (95% Confidence Interval)
Unit of Measure: months
4.75
(3.06 to 6.44)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Hide Arm/Group Description Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm B at the physician's discretion. Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
All-Cause Mortality
Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/6 (16.67%)      0/6 (0.00%)    
Metabolism and nutrition disorders     
Anorexia  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Dehydration  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle weakness  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Vascular disorders     
Thrombosis  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm A (Capecitabine) Arm B (Capecitabine+Sunitinib Malate)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   6/6 (100.00%)      6/6 (100.00%)    
Blood and lymphatic system disorders     
Febrile neutropenia  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Hemoglobin decreased  1  6/6 (100.00%)  29 6/6 (100.00%)  20
Cardiac disorders     
Left ventricular dysfunction  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Gastrointestinal disorders     
Abdominal distension  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Abdominal pain  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Constipation  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Diarrhea  1  4/6 (66.67%)  10 2/6 (33.33%)  6
Ear, nose and throat examination abnormal  1  2/6 (33.33%)  2 3/6 (50.00%)  3
Esophageal pain  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Esophagitis  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Gastritis  1  0/6 (0.00%)  0 1/6 (16.67%)  2
Mucositis oral  1  2/6 (33.33%)  4 2/6 (33.33%)  2
Nausea  1  6/6 (100.00%)  11 4/6 (66.67%)  10
Salivary gland disorder  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Upper gastrointestinal hemorrhage  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Vomiting  1  3/6 (50.00%)  5 3/6 (50.00%)  3
General disorders     
Fatigue  1  4/6 (66.67%)  9 3/6 (50.00%)  4
Injury, poisoning and procedural complications     
Gastrointestinal anastomotic leak  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Investigations     
Alkaline phosphatase increased  1  2/6 (33.33%)  9 2/6 (33.33%)  4
Aspartate aminotransferase increased  1  1/6 (16.67%)  2 1/6 (16.67%)  2
Creatinine increased  1  1/6 (16.67%)  1 2/6 (33.33%)  2
INR increased  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Leukocyte count decreased  1  3/6 (50.00%)  9 3/6 (50.00%)  10
Neutrophil count decreased  1  1/6 (16.67%)  5 3/6 (50.00%)  11
Platelet count decreased  1  1/6 (16.67%)  1 3/6 (50.00%)  11
Weight loss  1  0/6 (0.00%)  0 1/6 (16.67%)  8
Metabolism and nutrition disorders     
Anorexia  1  3/6 (50.00%)  3 1/6 (16.67%)  2
Dehydration  1  1/6 (16.67%)  1 1/6 (16.67%)  1
Serum albumin decreased  1  1/6 (16.67%)  2 1/6 (16.67%)  1
Serum calcium decreased  1  1/6 (16.67%)  2 0/6 (0.00%)  0
Serum magnesium decreased  1  1/6 (16.67%)  1 1/6 (16.67%)  8
Serum potassium decreased  1  3/6 (50.00%)  8 1/6 (16.67%)  1
Serum potassium increased  1  0/6 (0.00%)  0 2/6 (33.33%)  2
Serum sodium decreased  1  2/6 (33.33%)  8 3/6 (50.00%)  10
Serum sodium increased  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Muscle weakness  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Nervous system disorders     
Dizziness  1  2/6 (33.33%)  3 1/6 (16.67%)  1
Peripheral sensory neuropathy  1  3/6 (50.00%)  4 2/6 (33.33%)  6
Respiratory, thoracic and mediastinal disorders     
Cough  1  4/6 (66.67%)  8 2/6 (33.33%)  6
Dyspnea  1  3/6 (50.00%)  8 2/6 (33.33%)  3
Hiccough  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Pharyngeal examination abnormal  1  1/6 (16.67%)  1 2/6 (33.33%)  2
Pharyngeal mucositis  1  1/6 (16.67%)  2 1/6 (16.67%)  1
Pneumonitis  1  0/6 (0.00%)  0 1/6 (16.67%)  1
Skin and subcutaneous tissue disorders     
Hand-and-foot syndrome  1  3/6 (50.00%)  9 4/6 (66.67%)  9
Pruritus  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Rash desquamating  1  3/6 (50.00%)  4 2/6 (33.33%)  4
Vascular disorders     
Hypertension  1  0/6 (0.00%)  0 2/6 (33.33%)  2
Thrombosis  1  1/6 (16.67%)  1 0/6 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 12
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: Aminah Jatoi, M.D
Organization: Mayo Clinic
Phone: (507) 284-5352
EMail: jatoi.aminah@mayo.edu
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00891878     History of Changes
Other Study ID Numbers: NCCTG-N0747
NCI-2011-01920 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000641212 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: April 30, 2009
First Posted: May 1, 2009
Results First Submitted: February 15, 2017
Results First Posted: July 24, 2018
Last Update Posted: July 24, 2018