A Phase II Trial of Pre- and Postoperative Chemoradiotherapy and ZD1839 (IRESSA) Followed by Maintenance ZD1839 in Patients With Locoregionally Advanced Esophageal and Gastroesophageal Junction Carcinoma
18 Years
N/A
Both
Esophageal Cancer
Trial Information
A Phase II Trial of Pre- and Postoperative Chemoradiotherapy and ZD1839 (IRESSA) Followed by Maintenance ZD1839 in Patients With Locoregionally Advanced Esophageal and Gastroesophageal Junction Carcinoma
OBJECTIVES:
Primary
- Determine the activity of gefitinib, in terms of median survival and distant metastatic
disease control, in patients treated with neoadjuvant and adjuvant cisplatin,
fluorouracil, and radiotherapy who are undergoing surgery for esophageal and
gastroesophageal junction cancer.
Secondary
- Determine the pathologic complete and partial response rate in patients treated with
this regimen.
- Determine the toxicity of this regimen in these patients and in patients who are
disease free and receiving long-term maintenance gefitinib.
OUTLINE:
- Preoperative regimen: Patients undergo radiotherapy twice a day during days 1-12 (for a
total of 10 treatment days). Patients receive fluorouracil IV continuously and
cisplatin IV continuously on days 1-4. Patients also receive oral gefitinib once daily
on days 1-28. At 6 weeks, patients with locoregionally confined disease undergo
surgical resection and then proceed to the postoperative regimen. Patients with a
medical contraindication to surgery proceed directly to the postoperative regimen.
- Postoperative regimen: Beginning 4-10 weeks after surgery or 6 weeks after completing
the first course of therapy, patients undergo radiotherapy and receive fluorouracil and
cisplatin as in the preoperative regimen.
- Maintenance regimen: Patients receive oral gefitinib beginning on day 1 of the
postoperative regimen and continuing for 2 years in the absence of disease progression
or unacceptable toxicity.
After completion of study treatment, patients are followed periodically for 5 years.
PROJECTED ACCRUAL: A total of 80 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed squamous cell carcinoma, adenocarcinoma, or
large cell undifferentiated cancer of the esophagus or gastroesophageal junction
- T3, N1, or M1a disease only
- The following types are not allowed:
- Small cell undifferentiated carcinomas, lymphomas, or sarcomas
- Small cell or mixed small cell/non-small cell histology
- No evidence of distant hematogenous tumor metastases (M1b)
- No malignant pleural effusions
PATIENT CHARACTERISTICS:
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- WBC > 3,500/mm^3
- Platelet count > 100,000/mm^3
Hepatic
- Alkaline phosphatase < 2 times normal
- AST < 2 times normal
- No unstable or uncompensated hepatic disease
Renal
- Creatinine ≤ 2.0 mg/dL
- Calcium normal
- No unstable or uncompensated renal disease
Cardiovascular
- No unstable or uncontrolled angina
- No unstable or uncompensated cardiac disease
Pulmonary
- See Disease Characteristics
- No limitations to pulmonary function that would preclude study participation
- No evidence of clinically active interstitial lung disease (asymptomatic patients
with chronic stable radiographic changes are allowed)
- No unstable or uncompensated respiratory disease
Other
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No evidence of severe or uncontrolled systemic disease
- No other uncontrolled malignancy
- No active infection
- No known severe hypersensitivity to gefitinib or any of its excipients
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy for this cancer
Chemotherapy
- No prior chemotherapy for this cancer
Radiotherapy
- No prior radiotherapy for this cancer
Surgery
- Recovered from any prior oncologic or other major surgery
- No prior surgical resection for this cancer
- No concurrent ophthalmic surgery
Other
- No prior photodynamic therapy for this cancer (prior laser treatments are acceptable)
- More than 30 days since prior unapproved or investigational drug
- No concurrent phenytoin, carbamazepine, barbiturates, rifampin, phenobarbital, or
Hypericum perforatum (St. John's wort)
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Survival at 1 year
Outcome Description:
Survival at 1 year
Outcome Time Frame:
1 year
Safety Issue:
No
Principal Investigator
David J. Adelstein, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Authority:
United States: Food and Drug Administration
Study ID:
CCF5848
NCT ID:
NCT00258323
Start Date:
October 2005
Completion Date:
February 2010
Related Keywords:
- Esophageal Cancer
- adenocarcinoma of the esophagus
- squamous cell carcinoma of the esophagus
- stage II esophageal cancer
- stage III esophageal cancer
- stage IV esophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | Cleveland, Ohio 44195 |
