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

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2016-10-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Dose escalation study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Level -1

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

Group Type EXPERIMENTAL

Panitumumab

Intervention Type DRUG

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.

Dose Level 1

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

Group Type EXPERIMENTAL

Panitumumab

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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. -

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No