Cetuximab and Radiation Therapy for Surgically Resectable Esophageal and Gastroesophageal (GE) Junction Carcinomas

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The interaction of epidermal growth factor receptor (EGFR) inhibitory agents such as cetuximab combined with radiation shows promising results. EGFR inhibitory agents also enhance radiation-induced apoptosis and inhibit radiation induced damage repair. These interactions may represent the principle effects that contribute to the synergy between EGFR and radiation.

This trial will investigate the feasibility and activity of this combination in patients with surgically resectable disease.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Use of Cetuximab for Unresectable or Metastatic Esophageal and Gastric Cancer

NCT00130689

Esophageal Cancer Gastric Cancer Neoplasm Metastasis

COMPLETED PHASE2

Cetuximab, Docetaxel, Cisplatin, and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

NCT00445861

Esophageal Cancer

COMPLETED PHASE1/PHASE2

Radiation Therapy and Chemotherapy, With or Without Cetuximab, Followed by Surgery in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery

NCT01107639

Adenocarcinoma of the Gastroesophageal Junction Esophageal Cancer

COMPLETED PHASE3

Chemotherapy, Radiation Therapy, and Cetuximab Followed by Surgery, Docetaxel, and Cetuximab in Treating Patients With Esophageal Cancer or Gastroesophageal Junction Cancer

NCT00551759

Esophageal Cancer

TERMINATED PHASE2

Combination Chemotherapy and Cetuximab in Treating Patients With Metastatic Esophageal Cancer or Gastroesophageal Junction Cancer

NCT00381706

Esophageal Cancer

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

OUTLINE: This is a multi-center study.

* Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose)
* Cetuximab 250 mg/m2 IV over 60 minutes, day -7.
* Cetuximab 250 mg/m2 IV over 60 minutes, days 1, 8, 15, 22, 29 and 36.
* External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks.
* Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy.
* For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of cetuximab, and at the time of surgery for pathology submission.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Esophageal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Investigational Treatment

* Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose)
* Cetuximab 250 mg/m2 IV over 60 minutes Day -7
* Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36
* Combined with radiation therapy for six weeks.
* Surgery for esophageal resection after 6 to 8 week rest period.

Subjects who consent will provide tissue samples.

Group Type EXPERIMENTAL

Radiation Therapy

Intervention Type PROCEDURE

External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks

Surgery

Intervention Type PROCEDURE

Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy

Tissue Sample

Intervention Type PROCEDURE

For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Radiation Therapy

External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks

Intervention Type PROCEDURE

Surgery

Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy

Intervention Type PROCEDURE

Tissue Sample

For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Pathological diagnosis of either squamous cell carcinoma or adenocarcinoma of the esophagus or gastroesophageal junction.
* Clinical stage IIA, IIB or III without metastatic disease
* Patients must have documented EGFR status or have tumor tissue available for assessment of EGFR status by IHC
* Patients must be surgical candidates as determined by surgical consult.
* Patients must agree to surgery.
* ECOG performance status 0 or 2
* Absolute neutrophil count (ANC) \> 1,000 mm3
* Platelet count \> 75,000 mm3· Hemoglobin \> 10g/dL
* Bilirubin \< 2.5 X upper limit of normal
* AST (SGOT) or ALT (SGPT) \< 5.0 ´ upper limit of normal
* Creatinine \< 2.0 X upper limit of normal

Exclusion Criteria

* No history of or current brain metastasis.
* No significant history of uncontrolled cardiac disease; i.e. uncontrolled hypertension, unstable angina, recent myocardial infarction (within prior 6 months), uncontrolled congestive heart failure, and cardiomyopathy with decreased ejection fraction.
* No history of interstitial pneumonitis or pulmonary fibrosis, or suspicion of interstitial pneumonitis or pulmonary fibrosis on imaging.
* No concurrent chemotherapy not indicated in the study protocol or any other investigational agent(s).
* No prior use of radiation or chemotherapy for cancer of the esophagus or GE junction
* No prior therapy that specifically and directly targets the EGFR pathway (such as kinase inhibitors and antibodies directed against the HER family receptors).
* No prior severe infusion reaction to a monoclonal antibody.
* No major surgery within 28 days prior to being registered for protocol therapy.
* No clinically significant infections as judged by the treating investigator.
* No acute hepatitis or known HIV.
* No other active malignancies.
* Negative pregnancy test.
* No female patients currently breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No