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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00100945
Other study ID # NCCTG-N0342
Secondary ID NCI-2012-02644CD
Status Completed
Phase Phase 2
First received January 7, 2005
Last updated December 9, 2016
Start date July 2005
Est. completion date October 2009

Study information

Verified date December 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date October 2009
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
gefitinib


Locations

Country Name City State
United States Hickman Cancer Center at Bixby Medical Center Adrian Michigan
United States Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest Allentown Pennsylvania
United States McFarland Clinic, PC Ames Iowa
United States Rush-Copley Cancer Care Center Aurora Illinois
United States St. Francis Hospital and Health Centers - Beech Grove Campus Beech Grove Indiana
United States MeritCare Bemidji Bemidji Minnesota
United States St. Joseph Medical Center Bloomington Illinois
United States Wood County Oncology Center Bowling Green Ohio
United States Fairview Ridges Hospital Burnsville Minnesota
United States Graham Hospital Canton Illinois
United States Memorial Hospital Carthage Illinois
United States Cedar Rapids Oncology Associates Cedar Rapids Iowa
United States Cancer Center of Kansas, PA - Chanute Chanute Kansas
United States Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota
United States CCOP - Dayton Dayton Ohio
United States Good Samaritan Hospital Dayton Ohio
United States Grandview Hospital Dayton Ohio
United States Samaritan North Cancer Care Center Dayton Ohio
United States Veterans Affairs Medical Center - Dayton Dayton Ohio
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States John Stoddard Cancer Center Des Moines Iowa
United States John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at John Stoddard Cancer Center Des Moines Iowa
United States Medical Oncology and Hematology Associates at Mercy Cancer Center Des Moines Iowa
United States Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines Iowa
United States Mercy Capitol Hospital Des Moines Iowa
United States Cancer Center of Kansas, PA - Dodge City Dodge City Kansas
United States Fairview Southdale Hospital Edina Minnesota
United States Cancer Center of Kansas, PA - El Dorado El Dorado Kansas
United States Eureka Community Hospital Eureka Illinois
United States CCOP - MeritCare Hospital Fargo North Dakota
United States MeritCare Broadway Fargo North Dakota
United States Blanchard Valley Medical Associates Findlay Ohio
United States Fremont Memorial Hospital Fremont Ohio
United States Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota
United States Galesburg Clinic Galesburg Illinois
United States Galesburg Cottage Hospital Galesburg Illinois
United States Mason District Hospital Havana Illinois
United States Hopedale Medical Complex Hopedale Illinois
United States Hutchinson Area Health Care Hutchinson Minnesota
United States Mayo Clinic - Jacksonville Jacksonville Florida
United States Joliet Oncology-Hematology Associates, Limited - West Joliet Illinois
United States Kenton Oncology, Incorporated Kenton Ohio
United States Charles F. Kettering Memorial Hospital Kettering Ohio
United States Kewanee Hospital Kewanee Illinois
United States Cancer Center of Kansas, PA - Kingman Kingman Kansas
United States Franciscan Skemp Healthcare - La Crosse Campus La Crosse Wisconsin
United States Haematology-Oncology Associates of Ohio and Michigan, PC Lambertville Michigan
United States Southwest Medical Center Liberal Kansas
United States Meeker County Memorial Hospital Lichfield Minnesota
United States Lima Memorial Hospital Lima Ohio
United States McDonough District Hospital Macomb Illinois
United States HealthEast Cancer Care at St. John's Hospital Maplewood Minnesota
United States Minnesota Oncology Hematology, PA - Maplewood Maplewood Minnesota
United States Northwest Ohio Oncology Center Maumee Ohio
United States St. Luke's Hospital Maumee Ohio
United States Saint Anthony Memorial Health Centers Michigan City Indiana
United States Middletown Regional Hospital Middletown Ohio
United States Hennepin County Medical Center - Minneapolis Minneapolis Minnesota
United States Virginia Piper Cancer Institute at Abbott - Northwestern Hospital Minneapolis Minnesota
United States Mobile Infirmary Medical Center Mobile Alabama
United States Community Cancer Center of Monroe Monroe Michigan
United States Mercy Memorial Hospital - Monroe Monroe Michigan
United States Cancer Center of Kansas, PA - Newton Newton Kansas
United States BroMenn Regional Medical Center Normal Illinois
United States Community Cancer Center Normal Illinois
United States St. Charles Mercy Hospital Oregon Ohio
United States Toledo Clinic - Oregon Oregon Ohio
United States Community Hospital of Ottawa Ottawa Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Ottawa Ottawa Illinois
United States Cancer Center of Kansas, PA - Parsons Parsons Kansas
United States Cancer Treatment Center at Pekin Hospital Pekin Illinois
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States Oncology Hematology Associates of Central Illinois, PC - Peoria Peoria Illinois
United States OSF St. Francis Medical Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois Valley Community Hospital Peru Illinois
United States Cancer Center of Kansas, PA - Pratt Pratt Kansas
United States Rapid City Regional Hospital Rapid City South Dakota
United States Reid Hospital & Health Care Services, Incorporated Richmond Indiana
United States Hubert H. Humphrey Cancer Center at North Memorial Outpatient Center Robbinsdale Minnesota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States CCOP - Metro-Minnesota Saint Louis Park Minnesota
United States Cancer Center of Kansas, PA - Salina Salina Kansas
United States Firelands Regional Medical Center Sandusky Ohio
United States North Coast Cancer Care, Incorporated Sandusky Ohio
United States St. Francis Cancer Center at St. Francis Medical Center Shakopee Minnesota
United States Mercy Medical Center - Sioux City Sioux City Iowa
United States Siouxland Hematology-Oncology Associates, LLP Sioux City Iowa
United States St. Luke's Regional Medical Center Sioux City Iowa
United States St. Margaret's Hospital Spring Valley Illinois
United States HealthEast Cancer Care at St. Joseph's Hospital St Paul Minnesota
United States Park Nicollet Cancer Center St. Louis Park Minnesota
United States Regions Hospital Cancer Care Center St. Paul Minnesota
United States United Hospital St. Paul Minnesota
United States Flower Hospital Cancer Center Sylvania Ohio
United States Mercy Hospital of Tiffin Tiffin Ohio
United States CCOP - Toledo Community Hospital Toledo Ohio
United States Medical University of Ohio Cancer Center Toledo Ohio
United States St. Vincent Mercy Medical Center Toledo Ohio
United States Toledo Clinic, Incorporated - Main Clinic Toledo Ohio
United States Toledo Hospital Toledo Ohio
United States UVMC Cancer Care Center at Upper Valley Medical Center Troy Ohio
United States Carle Cancer Center at Carle Foundation Hospital Urbana Illinois
United States CCOP - Carle Cancer Center Urbana Illinois
United States Ridgeview Medical Center Waconia Minnesota
United States Fulton County Health Center Wauseon Ohio
United States Cancer Center of Kansas, PA - Wellington Wellington Kansas
United States Medical Oncology and Hematology Associates - West Des Moines West Des Moines Iowa
United States Associates in Womens Health, PA - North Review Wichita Kansas
United States Cancer Center of Kansas, PA - Medical Arts Tower Wichita Kansas
United States Cancer Center of Kansas, PA - Wichita Wichita Kansas
United States CCOP - Wichita Wichita Kansas
United States Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas
United States Cancer Center of Kansas, PA - Winfield Winfield Kansas
United States HealthEast Cancer Care at Woodwinds Health Campus Woodbury Minnesota
United States Minnesota Oncology Hematology, PA - Woodbury Woodbury Minnesota
United States Ruth G. McMillan Cancer Center at Greene Memorial Hospital Xenia Ohio

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 1-year overall survival rate Up to 12 months No
Secondary Survival time Up to 5 years No
Secondary Disease-free survival Up to 5 years No
Secondary Time to disease recurrence Up to 5 years No
Secondary Time to treatment failure Up to 5 years No
Secondary Quality of life Up to 5 years No
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