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A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cancer

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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 ClinicsMadison, Wisconsin  53792-0001