A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer
18 Years
N/A
Both
Cancer
Trial Information
A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer
Inclusion Criteria:
1. Locally Advanced Esophageal cancer (stages T1N1 or T2-4 any N)
2. Histology must be adenocarcinoma or squamous cell carcinoma
3. Must be surgical candidate based on evaluation by a thoracic surgeon
4. must have adequate organ function as defined by routine lab tests
Exclusion Criteria:
1. Insitu carcinoma
2. prior chemotherapy for esophageal cancer
3. Metastatic (stage IV disease)
4. Tumors <5cm from the cricopharyngeus muscle, Tumors with >75% of tumor located within
the stomach
5. Active, uncontrolled cardiac disease
6. subjects with >Grade 2 neuropathies. -
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:
MTD of panitumumab in combination with Cisplatin/fluorouracil and radiation for locally advanced esophageal cancer
Outcome Description:
From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post XRT/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information
Outcome Time Frame:
approximately 18 weeks
Safety Issue:
Yes
Authority:
United States: Food and Drug Administration
Study ID:
H-2009-0214
NCT ID:
NCT01128387
Start Date:
May 2010
Completion Date:
December 2013
Related Keywords:
- Cancer
- esophageal cancer
- Locally advanced esophageal cancer
- Esophageal Diseases
- Esophageal Neoplasms
Name | Location |
|---|---|
| University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
