Gefitinib in Treating Patients With Locally Advanced Esophageal Cancer
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: gefitinib Procedure: adjuvant therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: 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 |
- 1-year overall survival rate [ Designated as safety issue: No ]
- Survival time [ Designated as safety issue: No ]
- Disease-free survival [ Designated as safety issue: No ]
- Time to disease recurrence [ Designated as safety issue: No ]
- Time to treatment failure [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 72 |
| Study Start Date: | July 2005 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
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.
PROJECTED ACCRUAL: A total of 26-72 patients will be accrued for this study within 9-24 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Show 119 Study Locations| Study Chair: | Aminah Jatoi, MD | Mayo Clinic |
| Investigator: | George P. Kim, MD | Mayo Clinic |
| Investigator: | Jeff Sloan, PhD | Mayo Clinic |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00100945 History of Changes |
| Other Study ID Numbers: | CDR0000407534, NCCTG-N0342 |
| Study First Received: | January 7, 2005 |
| Last Updated: | October 13, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
adenocarcinoma of the esophagus stage II esophageal cancer |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Head and Neck Neoplasms Gefitinib Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Protein Kinase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on June 18, 2013