Radiotherapy,Chemotherapy,Before and After Surgery in Advanced Esophageal or Gastroesophageal Junction Cancer
This study has been completed.
Sponsor:
Case Comprehensive Cancer Center
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00258323
First received: November 22, 2005
Last updated: October 28, 2011
Last verified: October 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: cisplatin Drug: fluorouracil Drug: Iressa Procedure: conventional surgery Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Case Comprehensive Cancer Center:
Primary Outcome Measures:
- Survival at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]Survival at 1 year
- Distant metastatic control at 1 year [ Time Frame: 1 year ] [ Designated as safety issue: No ]Distant metastatic control at 1 year
Secondary Outcome Measures:
- Response rate at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]Response rate at 6 weeks
- Toxicity of induction chemoradiotherapy and gefitinib as measured by CTC version 2.0 at 6 weeks [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]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 [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Toxicity of maintenance gefitinib as measured by CTC version 2.0
| Enrollment: | 80 |
| Study Start Date: | October 2005 |
| Study Completion Date: | February 2010 |
| Primary Completion Date: | July 2007 (Final data collection date for primary outcome measure) |
Intervention Details:
Detailed Description:
-
Drug: cisplatin
20mg/m2d/IV continuous infusion x days
Other Name: CDDP
Drug: fluorouracil
1000mg/m2/d IV continuous infusion x 4 days
Other Name: 5 FU
Drug: Iressa
250mg po qd days 1-28 then x 2 years
Other Name: ZD 1839
Procedure: conventional surgery
conventional surgery
Other Name: conventional surgery
Radiation: radiation therapy
150 cGy bid
Other Name: radiation therapy
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00258323
Locations
| United States, Ohio | |
| Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
| Study Chair: | David J. Adelstein, MD | Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00258323 History of Changes |
| Other Study ID Numbers: | CCF5848, P30CA043703, CCF-5848, ZENECA-1839/US/0233 |
| Study First Received: | November 22, 2005 |
| Last Updated: | October 28, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Case Comprehensive Cancer Center:
|
adenocarcinoma of the esophagus squamous cell carcinoma of the esophagus stage II esophageal cancer stage III esophageal cancer stage IV 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 Cisplatin Fluorouracil |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors Protein Kinase Inhibitors Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013