A Phase I/II Study to Evaluate Safety and Efficacy in Patients Who Have Resectable Esophageal Cancer and Are Treated With Neoadjuvant Cisplatin, Irinotecan (CPT-11) ZD1839 (IRESSA), and Radiotherapy Followed by Surgical Resection
Trial Snapshot
- Phase
- Phase 1
- Status
- Terminated
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Pathological response (complete and partial) post-operatively
Study Overview
Brief Summary
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin and irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving gefitinib together with chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase I/II trial is studying the side effects of gefitinib when given together with cisplatin, irinotecan, and radiation therapy before surgery and to see how well they work in treating patients with esophageal cancer or gastroesophageal junction cancer that can be removed by surgery.
Detailed Description
OBJECTIVES:
Primary
- Evaluate the pathologic response (complete and partial) in patients with resectable esophageal or gastroesophageal junction cancer treated with neoadjuvant gefitinib, cisplatin, irinotecan hydrochloride, and radiotherapy followed by surgical resection.
Secondary
- Assess the safety and toxicity of this regimen in these patients.
- Evaluate objective tumor response in patients treated with this regimen.
- Determine the rate of complete resection in patients treated with this regimen.
- Determine surgical morbidity and mortality in patients treated with this regimen.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Pathological response (complete and partial) post-operatively
Secondary Outcomes
- Response rate 2 weeks into treatment, pre-operatively, and post-operatively
- Safety and toxicity post-operatively
- Compare the effects of gefitinib on biomarkers that effect EGF signaling and genomic composition of tumor samples before and after treatment
- Completeness of resection post-operatively
- Surgical morbidity and mortality post-operatively