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Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer

Primary Purpose

Esophageal Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
cisplatin
fluorouracil
Iressa
conventional surgery
radiation therapy
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esophageal Cancer focused on measuring adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Survival at 1 year
Survival at 1 year
Distant metastatic control at 1 year
Distant metastatic control at 1 year

Secondary Outcome Measures

Response rate at 6 weeks
Response rate at 6 weeks
Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks
Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks
Toxicity of maintenance gefitinib as measured by CTC version 2.0 every 8 weeks after the completion of radiotherapy
Toxicity of maintenance gefitinib as measured by CTC version 2.0

Full Information

First Posted
November 22, 2005
Last Updated
September 29, 2015
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00258323
Brief Title
Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
February 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Cisplatin and fluorouracil may also make tumor cells more sensitive to radiation therapy. Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving radiation therapy together with combination therapy and gefitinib before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving radiation therapy together with combination chemotherapy and gefitinib before and after surgery works in treating patients with advanced esophageal or gastroesophageal junction cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer
Keywords
adenocarcinoma of the esophagus, squamous cell carcinoma of the esophagus, stage II esophageal cancer, stage III esophageal cancer, stage IV esophageal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
cisplatin
Other Intervention Name(s)
CDDP
Intervention Description
20mg/m2d/IV continuous infusion x days
Intervention Type
Drug
Intervention Name(s)
fluorouracil
Other Intervention Name(s)
5 FU
Intervention Description
1000mg/m2/d IV continuous infusion x 4 days
Intervention Type
Drug
Intervention Name(s)
Iressa
Other Intervention Name(s)
ZD 1839
Intervention Description
250mg po qd days 1-28 then x 2 years
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
conventional surgery
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
150 cGy bid
Primary Outcome Measure Information:
Title
Survival at 1 year
Description
Survival at 1 year
Time Frame
1 year
Title
Distant metastatic control at 1 year
Description
Distant metastatic control at 1 year
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Response rate at 6 weeks
Description
Response rate at 6 weeks
Time Frame
6 weeks
Title
Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks
Description
Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks
Time Frame
6 weeks
Title
Toxicity of maintenance gefitinib as measured by CTC version 2.0 every 8 weeks after the completion of radiotherapy
Description
Toxicity of maintenance gefitinib as measured by CTC version 2.0
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J. Adelstein, MD
Organizational Affiliation
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Links:
URL
http://clinicaltrials.gov/ct2/results?term=ccf5848
Description
Clinical trial summary from the National Cancer Institute's PDQ® database

Learn more about this trial

Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer

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