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

Cancer Clinical Trial

Official title:

A Phase I/II Study of Panitumumab/Cisplatin/Fluorouracil Combined With Radiation Preoperatively for Patients With Locally Advanced Esophageal Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01128387
• Other study ID #: H-2009-0214
• Secondary ID: RO09211NCI-2011-
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: May 2010
• Est. completion date: October 2016

Study information

• Verified date: March 2018
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 (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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: October 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. -

Related Conditions & MeSH terms

• Cancer
• Esophageal Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	Amgen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	approximately 18 weeks
Secondary	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	20 weeks.

External Links

•   University of Wisconsin Carbone Cancer Center