Trial of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation in Esophageal Cancer

University of Wisconsin (UW)

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Cancer

Treatments: Drug: Panitumumab

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01128387

A533300 (Other Identifier)

NCI-2011-00735 (Registry Identifier)

RO09211 (Other Identifier)

SMPH\HUMAN ONCOLOGY\HUMAN ONCO (Other Identifier)

H-2009-0214

Details and patient eligibility

About

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 (Positron Emission Tomography) imaging to predict the degree of pathologic response.

All patients will have a pre-study FDG (F-18 Fluorodeoxyglucose) 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).

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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. -

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Dose Level -1

Experimental group

Description:

Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 60mg/m2 cisplatin, 750mg/m2 5FU (Fluorouracil)

Treatment:

Drug: Panitumumab

Dose Level 1

Experimental group

Description:

Panitumumab/Cisplatin/Fluorouracil and Radiation therapy 1.5mg/kg Panitumumab, 80mg/m2 cisplatin, 1000mg/m2 5FU (Fluorouracil)

Treatment:

Drug: Panitumumab