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

NCT01128387 | Terminated Phase 1 Results DMC

• 5 other identifiers: H-2009-0214RO09211NCI-2011-00735A533300SMPH\HUMAN ONCOLOGY\HUMAN ONCO
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Cancer

Keywords

esophageal cancer; Locally advanced esophageal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pathologic Response

  20 weeks.

Study Arms (2)

Dose Level -1

EXPERIMENTAL

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

Drug: Panitumumab

Dose Level 1

EXPERIMENTAL

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

Drug: Panitumumab

Interventions

Panitumumab 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; Dose Level 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Locally Advanced Esophageal cancer (stages T1N1 or T2-4 any N)
• Histology must be adenocarcinoma or squamous cell carcinoma
• Must be surgical candidate based on evaluation by a thoracic surgeon
• must have adequate organ function as defined by routine lab tests

You may not qualify if:

• Insitu carcinoma
• prior chemotherapy for esophageal cancer
• Metastatic (stage IV disease)
• Tumors \<5cm from the cricopharyngeus muscle, Tumors with \>75% of tumor located within the stomach
• Active, uncontrolled cardiac disease
• subjects with \>Grade 2 neuropathies. -

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Amgen: collaborator

Study Sites (1)

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Neoplasms; Esophageal Neoplasms

Interventions

Panitumumab

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The Standard of Care changed during this protocol, and the protocol was terminated prematurely.

Results Point of Contact

• Title: Dr. Mark Ritter
• Organization: University of Wisconsin Carbone Cancer Center

ritter@humonc.wisc.edu

608-263-8500

Study Officials

• Mark A Ritter, M.D., Ph.D.

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dose escalation study

Study Record Dates

• First Submitted: May 17, 2010
• First Posted: May 21, 2010
• Study Start: May 1, 2010
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: December 9, 2019
• Results First Posted: January 23, 2018

Record last verified: 2018-03

Locations

US (1)