Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Completed
CT.gov ID
NCT00100945
Collaborator
National Cancer Institute (NCI) (NIH)
70
119
1
51
0.6
0
Study Details
Study Description
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with locally advanced esophageal cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Detailed Description
OBJECTIVES:
Primary
- Determine the 1-year overall survival rate in patients with previously treated locally advanced adenocarcinoma of the esophagus or gastroesophageal junction treated with gefitinib as maintenance therapy.
Secondary
-
Determine disease-free survival and time to disease recurrence in patients treated with this drug.
-
Determine the toxicity of this drug in these patients.
-
Determine the quality of life of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity.
Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment.
Patients are followed every 3 months for up to 5 years.
Study Design
Study Type:
Interventional
Actual Enrollment
:
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study Of Maintenance ZD1839 (IRESSA) In Patients With Locally Advanced Esophageal Cancer After Treatment Given With Curative Intent
Study Start Date
:
Jul 1, 2005
Actual Primary Completion Date
:
Aug 1, 2007
Actual Study Completion Date
:
Oct 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: gefitinib Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease recurrence or unacceptable toxicity. Quality of life is assessed at baseline, 4 weeks, every 12 weeks during study treatment, and then at the end of study treatment. Patients are followed every 3 months for up to 5 years. |
Drug: gefitinib
|
Outcome Measures
Primary Outcome Measures
- 1-year overall survival rate [Up to 12 months]
Secondary Outcome Measures
- Survival time [Up to 5 years]
- Disease-free survival [Up to 5 years]
- Time to disease recurrence [Up to 5 years]
- Time to treatment failure [Up to 5 years]
- Quality of life [Up to 5 years]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
DISEASE CHARACTERISTICS:
-
Histologically or cytologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
-
Locally advanced disease
-
T3 or T4 tumor with no lymph node involvement OR any T stage with local lymph node involvement
-
Celiac node involvement allowed
-
No supraclavicular lymph node involvement
-
Received potentially curative chemotherapy, radiotherapy, and/or surgery within the past 1-3 months
-
Patients who received adjuvant chemotherapy or chemoradiotherapy after surgery are eligible provided last treatment was administered within the past 3 months
-
No evidence of residual tumor or metastatic disease after undergoing potentially curative therapy
-
No positive margins at the time of prior surgery
-
No measurable or evaluable disease
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 12 weeks
Hematopoietic
-
Absolute neutrophil count ≥ 1,500/mm^3
-
Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 2.0 mg/dL
Renal
- Creatinine ≤ 2 times upper limit of normal
Cardiovascular
- No New York Heart Association class III or IV heart disease
Other
-
Not pregnant or nursing
-
Negative pregnancy test
-
Fertile patients must use effective contraception
-
Able to swallow study drug
-
No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or noninvasive carcinoma
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- See Disease Characteristics
Surgery
- See Disease Characteristics
Other
-
No prior gefitinib
-
No concurrent CYP3A4 inducing agents, including any of the following:
-
Carbamazepine
-
Oxcarbazepine
-
Modafinil
-
Ethosuximide
-
Griseofulvin
-
Nafcillin
-
Phenobarbital
-
Phenylbutazone
-
Phenytoin
-
Primidone
-
Rifampin
-
Hypericum perforatum (St. John's wort)
-
Sulfinpyrazone
-
No concurrent antacids 4 hours before or after study drug administration
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mobile Infirmary Medical Center | Mobile | Alabama | United States | 36652-2144 |
| 2 | Mayo Clinic - Jacksonville | Jacksonville | Florida | United States | 32224 |
| 3 | Rush-Copley Cancer Care Center | Aurora | Illinois | United States | 60507 |
| 4 | St. Joseph Medical Center | Bloomington | Illinois | United States | 61701 |
| 5 | Graham Hospital | Canton | Illinois | United States | 61520 |
| 6 | Memorial Hospital | Carthage | Illinois | United States | 62321 |
| 7 | Eureka Community Hospital | Eureka | Illinois | United States | 61530 |
| 8 | Galesburg Clinic | Galesburg | Illinois | United States | 61401 |
| 9 | Galesburg Cottage Hospital | Galesburg | Illinois | United States | 61401 |
| 10 | Mason District Hospital | Havana | Illinois | United States | 62644 |
| 11 | Hopedale Medical Complex | Hopedale | Illinois | United States | 61747 |
| 12 | Joliet Oncology-Hematology Associates, Limited - West | Joliet | Illinois | United States | 60435 |
| 13 | Kewanee Hospital | Kewanee | Illinois | United States | 61443 |
| 14 | McDonough District Hospital | Macomb | Illinois | United States | 61455 |
| 15 | BroMenn Regional Medical Center | Normal | Illinois | United States | 61761 |
| 16 | Community Cancer Center | Normal | Illinois | United States | 61761 |
| 17 | Community Hospital of Ottawa | Ottawa | Illinois | United States | 61350 |
| 18 | Oncology Hematology Associates of Central Illinois, PC - Ottawa | Ottawa | Illinois | United States | 61350 |
| 19 | Cancer Treatment Center at Pekin Hospital | Pekin | Illinois | United States | 61554 |
| 20 | Proctor Hospital | Peoria | Illinois | United States | 61614 |
| 21 | CCOP - Illinois Oncology Research Association | Peoria | Illinois | United States | 61615 |
| 22 | Oncology Hematology Associates of Central Illinois, PC - Peoria | Peoria | Illinois | United States | 61615 |
| 23 | Methodist Medical Center of Illinois | Peoria | Illinois | United States | 61636 |
| 24 | OSF St. Francis Medical Center | Peoria | Illinois | United States | 61637 |
| 25 | Illinois Valley Community Hospital | Peru | Illinois | United States | 61354 |
| 26 | St. Margaret's Hospital | Spring Valley | Illinois | United States | 61362 |
| 27 | Carle Cancer Center at Carle Foundation Hospital | Urbana | Illinois | United States | 61801 |
| 28 | CCOP - Carle Cancer Center | Urbana | Illinois | United States | 61801 |
| 29 | St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove | Indiana | United States | 46107 |
| 30 | Saint Anthony Memorial Health Centers | Michigan City | Indiana | United States | 46360 |
| 31 | Reid Hospital & Health Care Services, Incorporated | Richmond | Indiana | United States | 47374 |
| 32 | McFarland Clinic, PC | Ames | Iowa | United States | 50010 |
| 33 | Cedar Rapids Oncology Associates | Cedar Rapids | Iowa | United States | 52403 |
| 34 | Mercy Capitol Hospital | Des Moines | Iowa | United States | 50307 |
| 35 | CCOP - Iowa Oncology Research Association | Des Moines | Iowa | United States | 50309 |
| 36 | John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines | Iowa | United States | 50309 |
| 37 | Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines | Iowa | United States | 50309 |
| 38 | Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines | Iowa | United States | 50314 |
| 39 | Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines | Iowa | United States | 50314 |
| 40 | John Stoddard Cancer Center | Des Moines | Iowa | United States | 50316-2301 |
| 41 | Siouxland Hematology-Oncology Associates, LLP | Sioux City | Iowa | United States | 51101 |
| 42 | Mercy Medical Center - Sioux City | Sioux City | Iowa | United States | 51104 |
| 43 | St. Luke's Regional Medical Center | Sioux City | Iowa | United States | 51104 |
| 44 | Medical Oncology and Hematology Associates - West Des Moines | West Des Moines | Iowa | United States | 50266 |
| 45 | Cancer Center of Kansas, PA - Chanute | Chanute | Kansas | United States | 66720 |
| 46 | Cancer Center of Kansas, PA - Dodge City | Dodge City | Kansas | United States | 67801 |
| 47 | Cancer Center of Kansas, PA - El Dorado | El Dorado | Kansas | United States | 67042 |
| 48 | Cancer Center of Kansas, PA - Kingman | Kingman | Kansas | United States | 67068 |
| 49 | Southwest Medical Center | Liberal | Kansas | United States | 67901 |
| 50 | Cancer Center of Kansas, PA - Newton | Newton | Kansas | United States | 67114 |
| 51 | Cancer Center of Kansas, PA - Parsons | Parsons | Kansas | United States | 67357 |
| 52 | Cancer Center of Kansas, PA - Pratt | Pratt | Kansas | United States | 67124 |
| 53 | Cancer Center of Kansas, PA - Salina | Salina | Kansas | United States | 67042 |
| 54 | Cancer Center of Kansas, PA - Wellington | Wellington | Kansas | United States | 67152 |
| 55 | Associates in Womens Health, PA - North Review | Wichita | Kansas | United States | 67203 |
| 56 | Cancer Center of Kansas, PA - Medical Arts Tower | Wichita | Kansas | United States | 67208 |
| 57 | Cancer Center of Kansas, PA - Wichita | Wichita | Kansas | United States | 67214 |
| 58 | CCOP - Wichita | Wichita | Kansas | United States | 67214 |
| 59 | Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita | Kansas | United States | 67214 |
| 60 | Cancer Center of Kansas, PA - Winfield | Winfield | Kansas | United States | 67156 |
| 61 | Hickman Cancer Center at Bixby Medical Center | Adrian | Michigan | United States | 49221 |
| 62 | Haematology-Oncology Associates of Ohio and Michigan, PC | Lambertville | Michigan | United States | 48144 |
| 63 | Community Cancer Center of Monroe | Monroe | Michigan | United States | 48162 |
| 64 | Mercy Memorial Hospital - Monroe | Monroe | Michigan | United States | 48162 |
| 65 | MeritCare Bemidji | Bemidji | Minnesota | United States | 56601 |
| 66 | Fairview Ridges Hospital | Burnsville | Minnesota | United States | 55337 |
| 67 | Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids | Minnesota | United States | 55433 |
| 68 | Fairview Southdale Hospital | Edina | Minnesota | United States | 55435 |
| 69 | Mercy and Unity Cancer Center at Unity Hospital | Fridley | Minnesota | United States | 55432 |
| 70 | Hutchinson Area Health Care | Hutchinson | Minnesota | United States | 55350 |
| 71 | Meeker County Memorial Hospital | Lichfield | Minnesota | United States | 55355 |
| 72 | HealthEast Cancer Care at St. John's Hospital | Maplewood | Minnesota | United States | 55109 |
| 73 | Minnesota Oncology Hematology, PA - Maplewood | Maplewood | Minnesota | United States | 55109 |
| 74 | Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 75 | Hennepin County Medical Center - Minneapolis | Minneapolis | Minnesota | United States | 55415 |
| 76 | Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale | Minnesota | United States | 55422-2900 |
| 77 | Mayo Clinic Cancer Center | Rochester | Minnesota | United States | 55905 |
| 78 | CCOP - Metro-Minnesota | Saint Louis Park | Minnesota | United States | 55416 |
| 79 | St. Francis Cancer Center at St. Francis Medical Center | Shakopee | Minnesota | United States | 55379 |
| 80 | HealthEast Cancer Care at St. Joseph's Hospital | St Paul | Minnesota | United States | 55102 |
| 81 | Park Nicollet Cancer Center | St. Louis Park | Minnesota | United States | 55416 |
| 82 | Regions Hospital Cancer Care Center | St. Paul | Minnesota | United States | 55101 |
| 83 | United Hospital | St. Paul | Minnesota | United States | 55102 |
| 84 | Ridgeview Medical Center | Waconia | Minnesota | United States | 55387 |
| 85 | HealthEast Cancer Care at Woodwinds Health Campus | Woodbury | Minnesota | United States | 55125 |
| 86 | Minnesota Oncology Hematology, PA - Woodbury | Woodbury | Minnesota | United States | 55125 |
| 87 | CCOP - MeritCare Hospital | Fargo | North Dakota | United States | 58122 |
| 88 | MeritCare Broadway | Fargo | North Dakota | United States | 58122 |
| 89 | Wood County Oncology Center | Bowling Green | Ohio | United States | 43402 |
| 90 | Grandview Hospital | Dayton | Ohio | United States | 45405 |
| 91 | Good Samaritan Hospital | Dayton | Ohio | United States | 45406 |
| 92 | Samaritan North Cancer Care Center | Dayton | Ohio | United States | 45415 |
| 93 | Veterans Affairs Medical Center - Dayton | Dayton | Ohio | United States | 45428 |
| 94 | CCOP - Dayton | Dayton | Ohio | United States | 45429 |
| 95 | Blanchard Valley Medical Associates | Findlay | Ohio | United States | 45840 |
| 96 | Fremont Memorial Hospital | Fremont | Ohio | United States | 43420 |
| 97 | Kenton Oncology, Incorporated | Kenton | Ohio | United States | 43326 |
| 98 | Charles F. Kettering Memorial Hospital | Kettering | Ohio | United States | 45429 |
| 99 | Lima Memorial Hospital | Lima | Ohio | United States | 45804 |
| 100 | Northwest Ohio Oncology Center | Maumee | Ohio | United States | 43537 |
| 101 | St. Luke's Hospital | Maumee | Ohio | United States | 43537 |
| 102 | Middletown Regional Hospital | Middletown | Ohio | United States | 45044 |
| 103 | St. Charles Mercy Hospital | Oregon | Ohio | United States | 43616 |
| 104 | Toledo Clinic - Oregon | Oregon | Ohio | United States | 43616 |
| 105 | Firelands Regional Medical Center | Sandusky | Ohio | United States | 44870 |
| 106 | North Coast Cancer Care, Incorporated | Sandusky | Ohio | United States | 44870 |
| 107 | Flower Hospital Cancer Center | Sylvania | Ohio | United States | 43560 |
| 108 | Mercy Hospital of Tiffin | Tiffin | Ohio | United States | 44883 |
| 109 | Toledo Hospital | Toledo | Ohio | United States | 43606 |
| 110 | St. Vincent Mercy Medical Center | Toledo | Ohio | United States | 43608 |
| 111 | Medical University of Ohio Cancer Center | Toledo | Ohio | United States | 43614 |
| 112 | CCOP - Toledo Community Hospital | Toledo | Ohio | United States | 43623 |
| 113 | Toledo Clinic, Incorporated - Main Clinic | Toledo | Ohio | United States | 43623 |
| 114 | UVMC Cancer Care Center at Upper Valley Medical Center | Troy | Ohio | United States | 45373-1300 |
| 115 | Fulton County Health Center | Wauseon | Ohio | United States | 43567 |
| 116 | Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia | Ohio | United States | 45385 |
| 117 | Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown | Pennsylvania | United States | 18105 |
| 118 | Rapid City Regional Hospital | Rapid City | South Dakota | United States | 57701 |
| 119 | Franciscan Skemp Healthcare - La Crosse Campus | La Crosse | Wisconsin | United States | 54601 |
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.Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00100945
Other Study ID Numbers:
- NCCTG-N0342
- NCI-2012-02644
- CDR0000407534
First Posted:
Jan 10, 2005
Last Update Posted:
Dec 13, 2016
Last Verified:
Dec 1, 2016
Keywords provided by Alliance for Clinical Trials in Oncology
Additional relevant MeSH terms: