S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus
Study Details
Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic or recurrent cancer of the esophagus.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 2 |
Detailed Description
OBJECTIVES:
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Determine the 6-month survival rate of patients with metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction treated with gemcitabine and irinotecan.
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Determine the qualitative and quantitative toxic effects of this regimen in these patients.
OUTLINE: Patients receive gemcitabine IV over 30 minutes and irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 30-55 patients will be accrued for this study.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Gemcitabine + Irinotecan Gemcitabine 1000mg/m2 IV over 30 min on Days 1,8 q21days; Irinotecan 100mg/m2 IV over 90 min on Days 1,8 q21days |
Drug: gemcitabine hydrochloride
1,000mg/m2, IV over 30 min, days 1 & 8, q 21 days
Other Names:
Drug: irinotecan hydrochloride
100 mg/m2, IV over 90 min, days 1 & 8, q 21days
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 6-month survival rate [6 months after registration]
To assess the six-month survival rate in patients with esophageal cancer treated with a gemcitabine-irinotecan combination chemotherapy regimen.
Secondary Outcome Measures
- Toxicities [Week 1 and Week 2 of each cycle]
To assess the qualitative and quantitative toxicities associated with this regimen in a Phase II study.
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
-
Histologically confirmed metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction
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Squamous cell carcinoma OR
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Adenocarcinoma
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No known brain metastases
PATIENT CHARACTERISTICS:
Age:
- 18 to 100
Performance status:
- Zubrod 0-2
Life expectancy:
- Not specified
Hematopoietic:
-
Granulocyte count at least 1,500/mm^3
-
Platelet count at least 100,000/mm^3
Hepatic:
- Not specified
Renal:
- Creatinine no greater than 1.5 times upper limit of normal
Cardiovascular:
-
No uncontrolled hypertension
-
No unstable angina
-
No symptomatic congestive heart failure
-
No myocardial infarction within the past 6 months
-
No serious uncontrolled cardiac arrhythmia
Gastrointestinal:
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No active inflammatory bowel disease
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No significant bowel obstruction
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No chronic diarrhea
Other:
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Not pregnant or nursing
-
Fertile patients must use effective contraception
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No active infection requiring systemic therapy
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No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer in complete remission
PRIOR CONCURRENT THERAPY:
Biologic therapy:
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At least 28 days since prior biologic therapy
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No prior biologic therapy for metastatic or recurrent disease
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No concurrent sargramostim (GM-CSF)
-
No concurrent immunotherapy for tumor
Chemotherapy:
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At least 28 days since prior chemotherapy
-
No prior chemotherapy for metastatic or recurrent disease
-
No prior gemcitabine or irinotecan
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Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized disease allowed
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No other concurrent chemotherapy for tumor
Endocrine therapy:
-
See Disease Characteristics
-
At least 28 days since prior endocrine therapy
-
No prior endocrine therapy for metastatic or recurrent disease
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No concurrent hormonal therapy for tumor
Radiotherapy:
-
At least 28 days since prior radiotherapy
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No prior radiotherapy for metastatic or recurrent disease
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Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized disease allowed
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No concurrent radiotherapy for tumor
Surgery:
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Prior thoraco-abdominal surgery allowed
-
At least 3 weeks since prior surgery and recovered
Other:
- No other concurrent anti-cancer therapy for tumor
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | MBCCOP - Gulf Coast | Mobile | Alabama | United States | 36688 |
2 | CCOP - Greater Phoenix | Phoenix | Arizona | United States | 85006-2726 |
3 | Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) | Phoenix | Arizona | United States | 85012 |
4 | Veterans Affairs Medical Center - Tucson | Tucson | Arizona | United States | 85723 |
5 | Arizona Cancer Center | Tucson | Arizona | United States | 85724 |
6 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
7 | Veterans Affairs Medical Center - Little Rock (McClellan) | Little Rock | Arkansas | United States | 72205 |
8 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010 |
9 | USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles | California | United States | 90033-0804 |
10 | Veterans Affairs Medical Center - West Los Angeles | Los Angeles | California | United States | 90073 |
11 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
12 | Veterans Affairs Outpatient Clinic - Martinez | Martinez | California | United States | 94553 |
13 | CCOP - Bay Area Tumor Institute | Oakland | California | United States | 94609-3305 |
14 | Chao Family Comprehensive Cancer Center | Orange | California | United States | 92868 |
15 | University of California Davis Medical Center | Sacramento | California | United States | 95817 |
16 | CCOP - Santa Rosa Memorial Hospital | Santa Rosa | California | United States | 95403 |
17 | David Grant Medical Center | Travis Air Force Base | California | United States | 94535 |
18 | University of Colorado Cancer Center | Denver | Colorado | United States | 80010 |
19 | Veterans Affairs Medical Center - Denver | Denver | Colorado | United States | 80220 |
20 | MBCCOP-Howard University Cancer Center | Washington | District of Columbia | United States | 20060 |
21 | CCOP - Atlanta Regional | Atlanta | Georgia | United States | 30342-1701 |
22 | Dwight David Eisenhower Army Medical Center | Fort Gordon | Georgia | United States | 30905-5650 |
23 | Cancer Research Center of Hawaii | Honolulu | Hawaii | United States | 96813-2424 |
24 | Tripler Army Medical Center | Honolulu | Hawaii | United States | 96859-5000 |
25 | MBCCOP - University of Illinois at Chicago | Chicago | Illinois | United States | 60612-7323 |
26 | Veterans Affairs Medical Center - Chicago (Westside Hospital) | Chicago | Illinois | United States | 60612 |
27 | CCOP - Central Illinois | Decatur | Illinois | United States | 62526 |
28 | Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) | Hines | Illinois | United States | 60141 |
29 | Loyola University Medical Center | Maywood | Illinois | United States | 60153 |
30 | University of Kansas Medical Center | Kansas City | Kansas | United States | 66160-7353 |
31 | CCOP - Wichita | Wichita | Kansas | United States | 67214-3882 |
32 | Veterans Affairs Medical Center - Wichita | Wichita | Kansas | United States | 67218 |
33 | Veterans Affairs Medical Center - Lexington | Lexington | Kentucky | United States | 40502-2236 |
34 | Albert B. Chandler Medical Center, University of Kentucky | Lexington | Kentucky | United States | 40536-0084 |
35 | MBCCOP - LSU Health Sciences Center | New Orleans | Louisiana | United States | 70112 |
36 | Tulane University School of Medicine | New Orleans | Louisiana | United States | 70112 |
37 | Louisiana State University Health Sciences Center - Shreveport | Shreveport | Louisiana | United States | 71130-3932 |
38 | Veterans Affairs Medical Center - Shreveport | Shreveport | Louisiana | United States | 71130 |
39 | Boston Medical Center | Boston | Massachusetts | United States | 02118 |
40 | Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain | Massachusetts | United States | 02130 |
41 | Veterans Affairs Medical Center - Ann Arbor | Ann Arbor | Michigan | United States | 48105 |
42 | CCOP - Ann Arbor Regional | Ann Arbor | Michigan | United States | 48106 |
43 | University of Michigan Comprehensive Cancer Center | Ann Arbor | Michigan | United States | 48109-0912 |
44 | Barbara Ann Karmanos Cancer Institute | Detroit | Michigan | United States | 48201-1379 |
45 | Veterans Affairs Medical Center - Detroit | Detroit | Michigan | United States | 48201-1932 |
46 | Henry Ford Hospital | Detroit | Michigan | United States | 48202 |
47 | CCOP - Grand Rapids Clinical Oncology Program | Grand Rapids | Michigan | United States | 49503 |
48 | CCOP - Beaumont | Royal Oak | Michigan | United States | 48073-6769 |
49 | Providence Hospital - Southfield | Southfield | Michigan | United States | 48075-9975 |
50 | CCOP - Duluth | Duluth | Minnesota | United States | 55805 |
51 | Veterans Affairs Medical Center - Biloxi | Biloxi | Mississippi | United States | 39531-2410 |
52 | University of Mississippi Medical Center | Jackson | Mississippi | United States | 39216-4505 |
53 | Veterans Affairs Medical Center - Jackson | Jackson | Mississippi | United States | 39216 |
54 | Keesler Medical Center - Keesler AFB | Keesler AFB | Mississippi | United States | 39534-2576 |
55 | Veterans Affairs Medical Center - Kansas City | Kansas City | Missouri | United States | 64128 |
56 | CCOP - Kansas City | Kansas City | Missouri | United States | 64131 |
57 | St. Louis University Health Sciences Center | Saint Louis | Missouri | United States | 63110 |
58 | CCOP - St. Louis-Cape Girardeau | Saint Louis | Missouri | United States | 63141 |
59 | CCOP - Cancer Research for the Ozarks | Springfield | Missouri | United States | 65807 |
60 | CCOP - Montana Cancer Consortium | Billings | Montana | United States | 59101 |
61 | Veterans Affairs Medical Center - Albuquerque | Albuquerque | New Mexico | United States | 87108-5138 |
62 | MBCCOP - University of New Mexico HSC | Albuquerque | New Mexico | United States | 87131 |
63 | Veterans Affairs Medical Center - Albany | Albany | New York | United States | 12208 |
64 | Herbert Irving Comprehensive Cancer Center | New York | New York | United States | 10032 |
65 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
66 | CCOP - Southeast Cancer Control Consortium | Winston-Salem | North Carolina | United States | 27104-4241 |
67 | Veterans Affairs Medical Center - Cincinnati | Cincinnati | Ohio | United States | 45220-2288 |
68 | Barrett Cancer Center, The University Hospital | Cincinnati | Ohio | United States | 45267-0501 |
69 | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio | United States | 44195-9001 |
70 | CCOP - Columbus | Columbus | Ohio | United States | 43206 |
71 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
72 | CCOP - Dayton | Kettering | Ohio | United States | 45429 |
73 | Oklahoma Medical Research Foundation | Oklahoma City | Oklahoma | United States | 73104 |
74 | Veterans Affairs Medical Center - Oklahoma City | Oklahoma City | Oklahoma | United States | 73104 |
75 | Veterans Affairs Medical Center - Portland | Portland | Oregon | United States | 97207 |
76 | CCOP - Columbia River Program | Portland | Oregon | United States | 97225 |
77 | OHSU Cancer Institute | Portland | Oregon | United States | 97239 |
78 | Veterans Affairs Medical Center - Charleston | Charleston | South Carolina | United States | 29401-5799 |
79 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425-0721 |
80 | CCOP - Greenville | Greenville | South Carolina | United States | 29615 |
81 | CCOP - Upstate Carolina | Spartanburg | South Carolina | United States | 29303 |
82 | Brooke Army Medical Center | Fort Sam Houston | Texas | United States | 78234-6200 |
83 | University of Texas Medical Branch | Galveston | Texas | United States | 77555-0565 |
84 | University of Texas - MD Anderson Cancer Center | Houston | Texas | United States | 77030-4095 |
85 | Veterans Affairs Medical Center - Houston | Houston | Texas | United States | 77030 |
86 | University of Texas Health Science Center at San Antonio | San Antonio | Texas | United States | 78284-7845 |
87 | Veterans Affairs Medical Center - San Antonio (Murphy) | San Antonio | Texas | United States | 78284 |
88 | Veterans Affairs Medical Center - Temple | Temple | Texas | United States | 76504 |
89 | CCOP - Scott and White Hospital | Temple | Texas | United States | 76508 |
90 | Huntsman Cancer Institute | Salt Lake City | Utah | United States | 84112-5550 |
91 | Veterans Affairs Medical Center - Salt Lake City | Salt Lake City | Utah | United States | 84148 |
92 | CCOP - Virginia Mason Research Center | Seattle | Washington | United States | 98101 |
93 | Swedish Cancer Institute | Seattle | Washington | United States | 98104 |
94 | Veterans Affairs Medical Center - Seattle | Seattle | Washington | United States | 98108 |
95 | CCOP - Northwest | Tacoma | Washington | United States | 98405-0986 |
96 | Madigan Army Medical Center | Tacoma | Washington | United States | 98431-5000 |
Sponsors and Collaborators
- Southwest Oncology Group
- National Cancer Institute (NCI)
Investigators
- Study Chair: Stephen K. Williamson, MD, University of Kansas
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CDR0000068515
- S0101
- U10CA032102