Phase 2 N=41 Treatment

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

Esophageal Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00319735 ↗

Enrolled (actual)

Serious AEs

39.0%

Results posted

Apr 2016

Primary outcome: Primary: Complete Pathologic Response (pCR) — 36.6 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Radiation Therapy (Procedure); Surgery (Procedure); Tissue Sample (Procedure)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Nasser Hanna, M.D.
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Complete Pathologic Response (pCR)	36.6	—
SECONDARY Complete Pathological Response Rate for Patients Who Underwent Esophagectomy.	48; 52	—
SECONDARY Time to Relief of Dysphagia	—	—
SECONDARY Evaluate Toxicity	3; 3; 7; 2; 2; 2	—
SECONDARY Perform Exploratory Molecular Correlates.	—	—
SECONDARY Complete and Partial Response Rate for Patients by Disease Stage: IIA	70	—
SECONDARY Complete and Partial Response Rate for Patients by Disease Stage: IIB	29	—
SECONDARY Complete and Partial Response Rate for Patients by Disease Stage: III	27	—
SECONDARY Complete and Partial Response Rate for Patients by Histology: Adenocarcinoma	28	—
SECONDARY Complete and Partial Response Rate for Patients by Histology: Squamous Cell	67	—

Summary

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00319735). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.