Overview

This trial has been completed.

Condition cancer
Treatment panitumumab
Phase phase 1/phase 2
Target EGFR
Sponsor University of Wisconsin, Madison
Collaborator Amgen
Start date May 2010
End date October 2016
Trial size 11 participants
Trial identifier NCT01128387, H-2009-0214, RO09211

Summary

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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.

Primary Outcomes

Measure
MTD of panitumumab in combination with Cisplatin/fluorouracil and radiation for locally advanced esophageal cancer
time frame: approximately 18 weeks

Secondary Outcomes

Measure
Pathologic response
time frame: 20 weeks.

Eligibility Criteria

Male or female participants at least 18 years old.

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. -

Additional Information

Official title A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Wisconsin, Madison.