Capecitabine With or Without Sunitinib Malate as First-Line Therapy in Treating Patients With Metastatic Cancer of the Esophagus or Gastroesophageal Junction
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as capecitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether capecitabine is more effective when given alone or together with sunitinib malate in treating patients with metastatic esophageal cancer or gastroesophageal junction cancer.
PURPOSE: This randomized phase II trial is studying how well capecitabine works compared with capecitabine given together with sunitinib malate as first-line therapy in treating patients with metastatic cancer of the esophagus or gastroesophageal junction.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
Primary
-
Compare the progression-free survival of elderly (age ≥ 65 years) and/or poor performance status patients with metastatic adenocarcinoma of the esophagus or gastroesophageal junction treated with capecitabine with verus without sunitinib malate.
-
Report other indicators of efficacy with these regimens, including the confirmed response rate, overall survival, time to tumor progression, duration of response, and time to treatment failure.
-
Compare the adverse event profiles of these regimens in these patients.
Secondary
-
Explore whether certain key proteins associated with anti-VEGF therapy are able to predict tumor response.
-
Bank paraffin-embedded tissue blocks or slides, and blood products for future studies.
OUTLINE: This is a multicenter study. Patients are stratified according to gender (male vs female), ECOG performance status (0 vs 1 vs 2), and age (≥ 65 years vs < 65 years). Patients are randomized to 1 of 2 treatment arms.
-
Arm I: Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion.
-
Arm II: Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21.
In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Tumor tissue samples are collected at baseline for evaluation of protein markers as possible predictors of tumor response to this regimen. Samples are analyzed by IHC for expression levels of markers
After completion of study therapy, patients are followed periodically for 3 years.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm I Patients receive oral capecitabine twice daily on days 1-14. Patients experiencing disease progression may crossover to arm II at the physician's discretion. |
Drug: capecitabine
Given orally
|
Experimental: Arm II Patients receive oral capecitabine as in arm 1 and oral sunitinib malate once daily on days 1-21. |
Drug: capecitabine
Given orally
Drug: sunitinib malate
Given orally
|
Outcome Measures
Primary Outcome Measures
- Comparison of Progression-free Survival [Up to 3 years]
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
Secondary Outcome Measures
- Response Rate (Complete Response or Partial Response) [Up to 3 years]
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.
- Overall Survival [Up to 3 years]
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 to Disease Progression [Up to 3 years]
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 to Treatment Failure [Up to 3 years]
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.
- Duration of Response [Up to 3 years]
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.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
-
Metastatic disease
-
Unresectable disease with no curative options
-
Measurable disease with ≥ 1 lesion whose longest diameter can be accurately measured as ≥ 2.0 cm by conventional techniques or ≥ 1.0 cm by spiral CT
-
Not a candidate for a conventional multi-drug chemotherapy regimen with fairly standard dosing (i.e., patient is able to tolerate at least 80% of standard dosing)
-
Patients who have been offered and declined conventional multi-drug chemotherapy are eligible
-
No known CNS metastases
PATIENT CHARACTERISTICS:
-
ECOG performance status (PS) 0-2 and age ≥ 65 years OR PS 2 and age ≥ 18 years but < 65 years
-
Absolute neutrophil count ≥ 1,500/mm^3
-
Platelet count ≥ 100,000/mm^3
-
Total bilirubin normal
-
Alkaline phosphatase ≤ 2 times upper limit of normal (ULN)
-
Creatinine ≤ 1.5 times ULN
-
Creatinine clearance ≥ 60mL/min
-
AST and ALT ≤ 2.5 times ULN (≤ 5 times ULN in the presence of liver metastases)
-
Not pregnant or nursing
-
Negative pregnancy test
-
Fertile patients must use effective contraception
-
Willing to provide tissue samples for central review and research purposes
-
Able to swallow pills
-
No immunocompromised patients (other than related to the use of corticosteroids), including patients known to be HIV-positive
-
No co-morbid systemic illnesses or other severe concurrent disease that, in the judgment of the investigator, would make the patient inappropriate for this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
-
No uncontrolled intercurrent illness including, but not limited to, any of the following:
-
Ongoing or active infection
-
Symptomatic congestive heart failure
-
Unstable angina pectoris
-
Cardiac arrhythmia
-
Psychiatric illness or social situations that would limit compliance with study requirements
-
No NYHA class III or IV heart failure
-
No uncontrolled hypertension except at the discretion of treating oncologist
-
No other active malignancy except for nonmelanoma skin cancer or carcinoma in situ of the cervix
-
No known dihydropyrimidine dehydrogenase deficiency (DPD)
PRIOR CONCURRENT THERAPY:
-
No prior chemotherapy, radiotherapy, immunotherapy, or biological therapy for recurrent or metastatic cancer
-
Prior chemotherapy or radiotherapy are allowed if they had been administered as adjuvant or neoadjuvant therapy and a complete surgical resection of the original cancer had been achieved
-
No prior sunitinib malate
-
No prior radiotherapy to > 30% of the marrow cavity at any time
-
More then 4 weeks since prior major surgery
-
At least 12 days since prior and no concurrent CYP3A4 inducers, including rifampin, rifabutin, carbamazepine, phenobarbital, phenytoin, St. John's wort, efavirenz, and tipranavir
-
At least 7 days since prior and no concurrent CYP3A4 inhibitors, including azole antifungals (ketoconazole, itraconazole), clarithromycin, erythromycin, diltiazem, verapamil, HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir), and delavirdine
-
No other concurrent specific treatment (other than hormonal therapy) in patients with a history of prior malignancy
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic Scottsdale | Scottsdale | Arizona | United States | 85259-5499 |
2 | Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford | Connecticut | United States | 06105 |
3 | Mayo Clinic - Jacksonville | Jacksonville | Florida | United States | 32224 |
4 | Illinois CancerCare - Bloomington | Bloomington | Illinois | United States | 61701 |
5 | St. Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
6 | Graham Hospital | Canton | Illinois | United States | 61520 |
7 | Illinois CancerCare - Canton | Canton | Illinois | United States | 61520 |
8 | Illinois CancerCare - Carthage | Carthage | Illinois | United States | 62321 |
9 | Memorial Hospital | Carthage | Illinois | United States | 62321 |
10 | Eureka Community Hospital | Eureka | Illinois | United States | 61530 |
11 | Illinois CancerCare - Eureka | Eureka | Illinois | United States | 61530 |
12 | Galesburg Clinic, PC | Galesburg | Illinois | United States | 61401 |
13 | Illinois CancerCare - Galesburg | Galesburg | Illinois | United States | 61401 |
14 | Illinois CancerCare - Havana | Havana | Illinois | United States | 62644 |
15 | Mason District Hospital | Havana | Illinois | United States | 62644 |
16 | Illinois CancerCare - Kewanee Clinic | Kewanee | Illinois | United States | 61443 |
17 | Illinois CancerCare - Macomb | Macomb | Illinois | United States | 61455 |
18 | McDonough District Hospital | Macomb | Illinois | United States | 61455 |
19 | Illinois CancerCare - Monmouth | Monmouth | Illinois | United States | 61462 |
20 | OSF Holy Family Medical Center | Monmouth | Illinois | United States | 61462 |
21 | BroMenn Regional Medical Center | Normal | Illinois | United States | 61761 |
22 | Community Cancer Center | Normal | Illinois | United States | 61761 |
23 | Illinois CancerCare - Community Cancer Center | Normal | Illinois | United States | 61761 |
24 | Community Hospital of Ottawa | Ottawa | Illinois | United States | 61350 |
25 | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | United States | 61350 |
26 | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | United States | 61554 |
27 | Illinois CancerCare - Pekin | Pekin | Illinois | United States | 61603 |
28 | Proctor Hospital | Peoria | Illinois | United States | 61614 |
29 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61615 |
30 | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | United States | 61615 |
31 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
32 | OSF St. Francis Medical Center | Peoria | Illinois | United States | 61637 |
33 | Illinois CancerCare - Peru | Peru | Illinois | United States | 61354 |
34 | Illinois Valley Community Hospital | Peru | Illinois | United States | 61354 |
35 | Illinois CancerCare - Princeton | Princeton | Illinois | United States | 61356 |
36 | Perry Memorial Hospital | Princeton | Illinois | United States | 61356 |
37 | Illinois CancerCare - Spring Valley | Spring Valley | Illinois | United States | 61362 |
38 | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | United States | 46107 |
39 | Reid Hospital & Health Care Services | Richmond | Indiana | United States | 47374 |
40 | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | United States | 52403 |
41 | Mercy Regional Cancer Center at Mercy Medical Center | Cedar Rapids | Iowa | United States | 52403 |
42 | Medical Oncology and Hematology Associates - West Des Moines | Clive | Iowa | United States | 50325 |
43 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309 |
44 | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
45 | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | United States | 50309 |
46 | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | United States | 50314 |
47 | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
48 | John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines | Iowa | United States | 50316 |
49 | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
50 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51104 |
51 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
52 | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | United States | 66720 |
53 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
54 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
55 | Cancer Center of Kansas - Fort Scott | Fort Scott | Kansas | United States | 66701 |
56 | Cancer Center of Kansas-Independence | Independence | Kansas | United States | 67301 |
57 | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | United States | 67068 |
58 | Lawrence Memorial Hospital | Lawrence | Kansas | United States | 66044 |
59 | Cancer Center of Kansas, PA - Liberal | Liberal | Kansas | United States | 67905 |
60 | Cancer Center of Kansas, PA - Newton | Newton | Kansas | United States | 67114 |
61 | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | United States | 67357 |
62 | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | United States | 67124 |
63 | Cancer Center of Kansas, PA - Salina | Salina | Kansas | United States | 67401 |
64 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
65 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
66 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
67 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
68 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
69 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
70 | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | United States | 49221 |
71 | Saint Joseph Mercy Cancer Center | Ann Arbor | Michigan | United States | 48106-0995 |
72 | CCOP - Michigan Cancer Research Consortium | Ann Arbor | Michigan | United States | 48106 |
73 | Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn | Michigan | United States | 48123-2500 |
74 | Genesys Hurley Cancer Institute | Flint | Michigan | United States | 48503 |
75 | Hurley Medical Center | Flint | Michigan | United States | 48503 |
76 | Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods | Michigan | United States | 48236 |
77 | Foote Memorial Hospital | Jackson | Michigan | United States | 49201 |
78 | Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | United States | 48144 |
79 | Sparrow Regional Cancer Center | Lansing | Michigan | United States | 48912-1811 |
80 | St. Mary Mercy Hospital | Livonia | Michigan | United States | 48154 |
81 | Community Cancer Center of Monroe | Monroe | Michigan | United States | 48162 |
82 | Mercy Memorial Hospital - Monroe | Monroe | Michigan | United States | 48162 |
83 | St. Joseph Mercy Oakland | Pontiac | Michigan | United States | 48341-2985 |
84 | Mercy Regional Cancer Center at Mercy Hospital | Port Huron | Michigan | United States | 48060 |
85 | Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw | Michigan | United States | 48601 |
86 | St. John Macomb Hospital | Warren | Michigan | United States | 48093 |
87 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
88 | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
89 | Duluth Clinic Cancer Center - Duluth | Duluth | Minnesota | United States | 55805-1983 |
90 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
91 | Miller - Dwan Medical Center | Duluth | Minnesota | United States | 55805 |
92 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
93 | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | United States | 55432 |
94 | Hutchinson Area Health Care | Hutchinson | Minnesota | United States | 55350 |
95 | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | United States | 55109 |
96 | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | United States | 55109 |
97 | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
98 | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55415 |
99 | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | United States | 55422-2900 |
100 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
101 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
102 | Park Nicollet Cancer Center | Saint Louis Park | Minnesota | United States | 55416 |
103 | Regions Hospital Cancer Care Center | Saint Paul | Minnesota | United States | 55101 |
104 | United Hospital | Saint Paul | Minnesota | United States | 55102 |
105 | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | United States | 55379 |
106 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
107 | Willmar Cancer Center at Rice Memorial Hospital | Willmar | Minnesota | United States | 56201 |
108 | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | United States | 55125 |
109 | Missouri Baptist Cancer Center | Saint Louis | Missouri | United States | 63131 |
110 | Arch Medical Services, Incorporated at Center for Cancer Care and Research | Saint Louis | Missouri | United States | 63141 |
111 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
112 | Northern Rockies Radiation Oncology Center | Billings | Montana | United States | 59101 |
113 | St. Vincent Healthcare Cancer Care Services | Billings | Montana | United States | 59101 |
114 | Hematology-Oncology Centers of the Northern Rockies - Billings | Billings | Montana | United States | 59102 |
115 | Billings Clinic - Downtown | Billings | Montana | United States | 59107-7000 |
116 | Bozeman Deaconess Cancer Center | Bozeman | Montana | United States | 59715 |
117 | St. James Healthcare Cancer Care | Butte | Montana | United States | 59701 |
118 | Great Falls Clinic - Main Facility | Great Falls | Montana | United States | 59405 |
119 | Sletten Cancer Institute at Benefis Healthcare | Great Falls | Montana | United States | 59405 |
120 | Northern Montana Hospital | Havre | Montana | United States | 59501 |
121 | St. Peter's Hospital | Helena | Montana | United States | 59601 |
122 | Glacier Oncology, PLLC | Kalispell | Montana | United States | 59901 |
123 | Kalispell Medical Oncology at KRMC | Kalispell | Montana | United States | 59901 |
124 | Montana Cancer Specialists at Montana Cancer Center | Missoula | Montana | United States | 59807-7877 |
125 | Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula | Montana | United States | 59807 |
126 | Cancer Resource Center - Lincoln | Lincoln | Nebraska | United States | 68510 |
127 | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska | United States | 68106 |
128 | Immanuel Medical Center | Omaha | Nebraska | United States | 68122 |
129 | Alegant Health Cancer Center at Bergan Mercy Medical Center | Omaha | Nebraska | United States | 68124 |
130 | Creighton University Medical Center | Omaha | Nebraska | United States | 68131-2197 |
131 | Rutherford Hospital | Rutherfordton | North Carolina | United States | 28139 |
132 | Bismarck Cancer Center | Bismarck | North Dakota | United States | 58501 |
133 | Medcenter One Hospital Cancer Care Center | Bismarck | North Dakota | United States | 58501 |
134 | Mid Dakota Clinic, PC | Bismarck | North Dakota | United States | 58501 |
135 | St. Alexius Medical Center Cancer Center | Bismarck | North Dakota | United States | 58502 |
136 | Altru Cancer Center at Altru Hospital | Grand Forks | North Dakota | United States | 58201 |
137 | Wood County Oncology Center | Bowling Green | Ohio | United States | 43402 |
138 | North Coast Cancer Care - Clyde | Clyde | Ohio | United States | 43410 |
139 | Grandview Hospital | Dayton | Ohio | United States | 45405 |
140 | Good Samaritan Hospital | Dayton | Ohio | United States | 45406 |
141 | David L. Rike Cancer Center at Miami Valley Hospital | Dayton | Ohio | United States | 45409 |
142 | Samaritan North Cancer Care Center | Dayton | Ohio | United States | 45415 |
143 | CCOP - Dayton | Dayton | Ohio | United States | 45420 |
144 | Community Cancer Center | Elyria | Ohio | United States | 44035 |
145 | Hematology Oncology Center | Elyria | Ohio | United States | 44035 |
146 | Blanchard Valley Medical Associates | Findlay | Ohio | United States | 45840 |
147 | Middletown Regional Hospital | Franklin | Ohio | United States | 45005-1066 |
148 | Wayne Hospital | Greenville | Ohio | United States | 45331 |
149 | Charles F. Kettering Memorial Hospital | Kettering | Ohio | United States | 45429 |
150 | Lima Memorial Hospital | Lima | Ohio | United States | 45804 |
151 | Northwest Ohio Oncology Center | Maumee | Ohio | United States | 43537-1839 |
152 | St. Luke's Hospital | Maumee | Ohio | United States | 43537 |
153 | Fisher-Titus Medical Center | Norwalk | Ohio | United States | 44857 |
154 | St. Charles Mercy Hospital | Oregon | Ohio | United States | 43616 |
155 | Toledo Clinic - Oregon | Oregon | Ohio | United States | 43616 |
156 | North Coast Cancer Care, Incorporated | Sandusky | Ohio | United States | 44870 |
157 | Flower Hospital Cancer Center | Sylvania | Ohio | United States | 43560 |
158 | Mercy Hospital of Tiffin | Tiffin | Ohio | United States | 44883 |
159 | Toledo Hospital | Toledo | Ohio | United States | 43606 |
160 | St. Vincent Mercy Medical Center | Toledo | Ohio | United States | 43608 |
161 | Medical University of Ohio Cancer Center | Toledo | Ohio | United States | 43614 |
162 | CCOP - Toledo Community Hospital | Toledo | Ohio | United States | 43617 |
163 | St. Anne Mercy Hospital | Toledo | Ohio | United States | 43623 |
164 | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | United States | 43623 |
165 | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | United States | 45373-1300 |
166 | Fulton County Health Center | Wauseon | Ohio | United States | 43567 |
167 | Clinton Memorial Hospital | Wilmington | Ohio | United States | 45177 |
168 | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | United States | 45385 |
169 | Geisinger Cancer Institute at Geisinger Health | Danville | Pennsylvania | United States | 17822-0001 |
170 | Geisinger Hazleton Cancer Center | Hazleton | Pennsylvania | United States | 18201 |
171 | Geisinger Medical Group - Scenery Park | State College | Pennsylvania | United States | 16801 |
172 | Frank M. and Dorothea Henry Cancer Center at Geisinger Wyoming Valley Medical Center | Wilkes-Barre | Pennsylvania | United States | 18711 |
173 | AnMed Cancer Center | Anderson | South Carolina | United States | 29621 |
174 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
175 | Gibbs Regional Cancer Center at Spartanburg Regional Medical Center | Spartanburg | South Carolina | United States | 29303 |
176 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
177 | Avera Cancer Institute | Sioux Falls | South Dakota | United States | 57105 |
178 | Medical X-Ray Center, PC | Sioux Falls | South Dakota | United States | 57105 |
179 | Sanford Cancer Center at Sanford USD Medical Center | Sioux Falls | South Dakota | United States | 57117-5039 |
180 | Fredericksburg Oncology, Incorporated | Fredericksburg | Virginia | United States | 22401 |
181 | Rocky Mountain Oncology | Casper | Wyoming | United States | 82609 |
182 | Welch Cancer Center at Sheridan Memorial Hospital | Sheridan | Wyoming | United States | 82801 |
Sponsors and Collaborators
- Alliance for Clinical Trials in Oncology
- National Cancer Institute (NCI)
Investigators
- Study Chair: Aminah Jatoi, MD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- NCCTG-N0747
- NCI-2011-01920
- CDR0000641212
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib) |
---|---|---|
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 |
Baseline Characteristics
Arm/Group Title | Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib) | Total |
---|---|---|---|
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 Participants | 6 | 6 | 12 |
Age (years) [Median (Full Range) ] | |||
Median (Full Range) [years] |
74.5
|
73
|
73
|
Sex: Female, Male (Count of Participants) | |||
Female |
1
16.7%
|
0
0%
|
1
8.3%
|
Male |
5
83.3%
|
6
100%
|
11
91.7%
|
Ethnicity (NIH/OMB) (Count of Participants) | |||
Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
Not Hispanic or Latino |
6
100%
|
6
100%
|
12
100%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
Outcome Measures
Title | Comparison of Progression-free Survival |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
All evaluable patients |
Arm/Group Title | Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib Malate) |
---|---|---|
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. |
Measure Participants | 6 | 6 |
Median (95% Confidence Interval) [Months] |
6.1
|
2.4
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Arm A (Capecitabine), Arm B (Capecitabine+Sunitinib Malate) |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.43 |
Comments | ||
Method | Log Rank | |
Comments |
Title | Response Rate (Complete Response or Partial Response) |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
All evaluable patients |
Arm/Group Title | Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib Malate) |
---|---|---|
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. |
Measure Participants | 6 | 6 |
Number (95% Confidence Interval) [percentage of patients] |
0
|
33
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | Arm A (Capecitabine), Arm B (Capecitabine+Sunitinib Malate) |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.45 |
Comments | ||
Method | Fisher Exact | |
Comments |
Title | Overall Survival |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
All evaluable patients |
Arm/Group Title | Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib Malate) |
---|---|---|
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. |
Measure Participants | 6 | 6 |
Median (95% Confidence Interval) [Months] |
6.2
|
5.9
|
Title | Time to Disease Progression |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
All evaluable patients |
Arm/Group Title | Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib Malate) |
---|---|---|
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. |
Measure Participants | 6 | 6 |
Median (95% Confidence Interval) [months] |
7.56
|
2.46
|
Title | Time to Treatment Failure |
---|---|
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 |
Outcome Measure Data
Analysis Population Description |
---|
All evaluable patients |
Arm/Group Title | Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib Malate) |
---|---|---|
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. |
Measure Participants | 6 | 6 |
Median (95% Confidence Interval) [months] |
1.63
|
2.53
|
Title | Duration of Response |
---|---|
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 |
Outcome Measure Data
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) |
---|---|---|
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. |
Measure Participants | 0 | 2 |
Median (95% Confidence Interval) [months] |
4.75
|
Adverse Events
Time Frame | ||||
---|---|---|---|---|
Adverse Event Reporting Description | ||||
Arm/Group Title | Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib Malate) | ||
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 (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib Malate) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 1/6 (16.7%) | 0/6 (0%) | ||
Metabolism and nutrition disorders | ||||
Anorexia | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Dehydration | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Muscle weakness | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Vascular disorders | ||||
Thrombosis | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Other (Not Including Serious) Adverse Events |
||||
Arm A (Capecitabine) | Arm B (Capecitabine+Sunitinib Malate) | |||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 6/6 (100%) | 6/6 (100%) | ||
Blood and lymphatic system disorders | ||||
Febrile neutropenia | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Hemoglobin decreased | 6/6 (100%) | 29 | 6/6 (100%) | 20 |
Cardiac disorders | ||||
Left ventricular dysfunction | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Gastrointestinal disorders | ||||
Abdominal distension | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Abdominal pain | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Constipation | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Diarrhea | 4/6 (66.7%) | 10 | 2/6 (33.3%) | 6 |
Ear, nose and throat examination abnormal | 2/6 (33.3%) | 2 | 3/6 (50%) | 3 |
Esophageal pain | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Esophagitis | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Gastritis | 0/6 (0%) | 0 | 1/6 (16.7%) | 2 |
Mucositis oral | 2/6 (33.3%) | 4 | 2/6 (33.3%) | 2 |
Nausea | 6/6 (100%) | 11 | 4/6 (66.7%) | 10 |
Salivary gland disorder | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Upper gastrointestinal hemorrhage | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Vomiting | 3/6 (50%) | 5 | 3/6 (50%) | 3 |
General disorders | ||||
Fatigue | 4/6 (66.7%) | 9 | 3/6 (50%) | 4 |
Injury, poisoning and procedural complications | ||||
Gastrointestinal anastomotic leak | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Investigations | ||||
Alkaline phosphatase increased | 2/6 (33.3%) | 9 | 2/6 (33.3%) | 4 |
Aspartate aminotransferase increased | 1/6 (16.7%) | 2 | 1/6 (16.7%) | 2 |
Creatinine increased | 1/6 (16.7%) | 1 | 2/6 (33.3%) | 2 |
INR increased | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Leukocyte count decreased | 3/6 (50%) | 9 | 3/6 (50%) | 10 |
Neutrophil count decreased | 1/6 (16.7%) | 5 | 3/6 (50%) | 11 |
Platelet count decreased | 1/6 (16.7%) | 1 | 3/6 (50%) | 11 |
Weight loss | 0/6 (0%) | 0 | 1/6 (16.7%) | 8 |
Metabolism and nutrition disorders | ||||
Anorexia | 3/6 (50%) | 3 | 1/6 (16.7%) | 2 |
Dehydration | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 1 |
Serum albumin decreased | 1/6 (16.7%) | 2 | 1/6 (16.7%) | 1 |
Serum calcium decreased | 1/6 (16.7%) | 2 | 0/6 (0%) | 0 |
Serum magnesium decreased | 1/6 (16.7%) | 1 | 1/6 (16.7%) | 8 |
Serum potassium decreased | 3/6 (50%) | 8 | 1/6 (16.7%) | 1 |
Serum potassium increased | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 |
Serum sodium decreased | 2/6 (33.3%) | 8 | 3/6 (50%) | 10 |
Serum sodium increased | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Musculoskeletal and connective tissue disorders | ||||
Muscle weakness | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Nervous system disorders | ||||
Dizziness | 2/6 (33.3%) | 3 | 1/6 (16.7%) | 1 |
Peripheral sensory neuropathy | 3/6 (50%) | 4 | 2/6 (33.3%) | 6 |
Respiratory, thoracic and mediastinal disorders | ||||
Cough | 4/6 (66.7%) | 8 | 2/6 (33.3%) | 6 |
Dyspnea | 3/6 (50%) | 8 | 2/6 (33.3%) | 3 |
Hiccough | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Pharyngeal examination abnormal | 1/6 (16.7%) | 1 | 2/6 (33.3%) | 2 |
Pharyngeal mucositis | 1/6 (16.7%) | 2 | 1/6 (16.7%) | 1 |
Pneumonitis | 0/6 (0%) | 0 | 1/6 (16.7%) | 1 |
Skin and subcutaneous tissue disorders | ||||
Hand-and-foot syndrome | 3/6 (50%) | 9 | 4/6 (66.7%) | 9 |
Pruritus | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Rash desquamating | 3/6 (50%) | 4 | 2/6 (33.3%) | 4 |
Vascular disorders | ||||
Hypertension | 0/6 (0%) | 0 | 2/6 (33.3%) | 2 |
Thrombosis | 1/6 (16.7%) | 1 | 0/6 (0%) | 0 |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE 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
Name/Title | Aminah Jatoi, M.D |
---|---|
Organization | Mayo Clinic |
Phone | (507) 284-5352 |
jatoi.aminah@mayo.edu |
- NCCTG-N0747
- NCI-2011-01920
- CDR0000641212