S0101 Gemcitabine and Irinotecan in Treating Patients With Metastatic or Recurrent Cancer of the Esophagus

Sponsor

Southwest Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00012363

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

Duration (Months)

0.6

Patients Per Site

Patients Per Site Per Month

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
Esophageal Cancer Gastric Cancer	Drug: gemcitabine hydrochloride Drug: irinotecan hydrochloride	Phase 2

Detailed Description

OBJECTIVES:

Determine the 6-month survival rate of patients with metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction treated with gemcitabine and irinotecan.
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

Study Type:

Interventional

Actual Enrollment :

61 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Gemcitabine Plus Irinotecan in Patients With Esophageal Cancer, Phase II

Study Start Date :

Apr 1, 2001

Actual Primary Completion Date :

Apr 1, 2006

Actual Study Completion Date :

Apr 1, 2006

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: Gemzar (NSC-613327) Drug: irinotecan hydrochloride 100 mg/m2, IV over 90 min, days 1 & 8, q 21days Other Names: CPT-11 (NSC-616348)

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:

Gemzar (NSC-613327)

Drug: irinotecan hydrochloride

100 mg/m2, IV over 90 min, days 1 & 8, q 21days

Other Names:

CPT-11 (NSC-616348)

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

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed metastatic or recurrent carcinoma of the esophagus or gastroesophageal junction
Squamous cell carcinoma OR
Adenocarcinoma
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:

No active inflammatory bowel disease
No significant bowel obstruction
No chronic diarrhea

Other:

Not pregnant or nursing
Fertile patients must use effective contraception
No active infection requiring systemic therapy
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:

At least 28 days since prior biologic therapy
No prior biologic therapy for metastatic or recurrent disease
No concurrent sargramostim (GM-CSF)
No concurrent immunotherapy for tumor

Chemotherapy:

At least 28 days since prior chemotherapy
No prior chemotherapy for metastatic or recurrent disease
No prior gemcitabine or irinotecan
Prior adjuvant or neoadjuvant chemotherapy at time of initial diagnosis of localized disease allowed
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
No concurrent hormonal therapy for tumor

Radiotherapy:

At least 28 days since prior radiotherapy
No prior radiotherapy for metastatic or recurrent disease
Prior adjuvant or neoadjuvant radiotherapy at time of initial diagnosis of localized disease allowed
No concurrent radiotherapy for tumor

Surgery:

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