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

Phase 2TerminatedNCT01128387

University of Wisconsin, Madison11 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Cancer

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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. -

Outcomes

Primary Outcomes

MTD of Panitumumab in Combination With Cisplatin/Fluorouracil and Radiation for Locally Advanced Esophageal Cancer Determined by Number of Participants Experiencing DLT

Maximum Tolerated Dose (MTD) will be where 0 of 6 patients experienced Dose Limiting Toxicities (DLT) from start until 28 days after the completion of radiation. The investigator considered DLTs related to the treatment to be: grade 4 hematologic toxicity, grade 3 hematologic toxicity lasting \>7 days, any neutropenic fever, all grade 3 non-hematologic toxicities (excluding alopecia and nausea/vomiting/diarrhea if controlled with antiemetics or anti-diarrheal agents), grade 4 lab abnormality (whether symptomatic or asymptomatic), any treatment related to death, any toxicity associated with 1) any single interruption of radiation \>10 treatment days, 2) \>2 interruptions of radiation per course, 3) a delay in completion of radiation by \>14 days beyond planned treatment schedule, 4) inability to deliver \>80% of planned treatment doses, 5) any infield grade 4 toxicity

Time frame: approximately 18 weeks

Secondary Outcomes

Pathologic Response

From therapy initiation through 30 days post surgery. 5.5 weeks of XRT/chemo, 4-8weeks post Radiation (XRT)/Chemo subjects to undergo a surgical resection, and study will be completed 4 weeks post surgery with surgical morbidity and mortality information

Time frame: 20 weeks.