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Trial of Panitumumab/Cisplatin/Fluorouracil With XRT in Esophageal Cancer

This study is currently recruiting participants.
Verified November 2012 by University of Wisconsin, Madison
Sponsor:
Collaborator:
Amgen
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT01128387
First received: May 17, 2010
Last updated: November 27, 2012
Last verified: November 2012
History of Changes
  Purpose

The overall study objective is to evaluate the dose limiting toxicities and the recommended phase II dose of Panitumumab when combined with the standard of care treatment with cisplatin, fluorouracil and radiation in patients with locally advanced esophageal cancer. The investigators will also be assessing the ability of PET imaging to predict the degree of pathologic response.

All patients will have a pre-study FDG PET scan and will receive radiation therapy and chemotherapy over a 35 day period. 4-8 weeks post radiation and chemotherapy patients will be restaged with a PET/CT scan. It is anticipated that approximately 30 patients enrolled will undergo an esophagectomy which is considered standard of care post radiation and chemotherapy. The surgery will allow us to compare this study regimen to the historical standard of care (Cisplatin/fluorouracil chemotherapy with radiation therapy).


Condition Intervention Phase
Cancer
 Drug: Panitumumab
 Phase 1
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 I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • MTD of panitumumab in combination with Cisplatin/fluorouracil and radiation for locally advanced esophageal cancer [ Time Frame: approximately 18 weeks ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • Pathologic response [ Time Frame: 20 weeks. ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 36
Study Start Date: May 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Panitumumab/Cisplatin/Fluorouracil and Radiation therapy Drug: Panitumumab
dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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. -
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01128387

Locations
United States, Wisconsin
University of Wisconsin Hospital and Clinics Recruiting
Madison, Wisconsin, United States, 53792
Contact: Mark Ritter, M.D., Ph.D.     608-263-8500     ritter@humonc.wisc.edu    
Contact: Diana Trask, BS     608-263-9528     trask@humonc.wisc.edu    
Principal Investigator: Mark Ritter, M.D., Ph.D            
Sponsors and Collaborators
University of Wisconsin, Madison
Amgen
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT01128387     History of Changes
Other Study ID Numbers: H-2009-0214
Study First Received: May 17, 2010
Last Updated: November 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Wisconsin, Madison:
esophageal cancer
Locally advanced 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
Cisplatin
Fluorouracil
 Antibodies, Monoclonal
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

ClinicalTrials.gov processed this record on May 19, 2013