Chemotherapy Induction and Chemoradiotherapy in Patients With Esophageal Carcinoma

• Status: Terminated
• Trial end date: 2012-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of this study is the evaluate the feasibility and safety of chemotherapy induction treatment combined with cetuximab followed by chemoradiotherapy combined with cetuximab in the treatment of patients with non-metastatic esophageal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Collaborators: Merck Sharp & Dohme Corp.; Sanofi
• Treatments: Cetuximab; Docetaxel

Criteria

Inclusion Criteria:

• Signed informed consent

• histologically confirmed esophageal cancer (squamous cell carcinoma)

• measurable, non-metastatic disease (uT1-4)

• no previous cancer therapy (chemotherapy, radiotherapy or resection)

• life expectancy > 3 months

• age > 18 years

• WHO Status ≤ 2

• negative pregnancy test for women of child-bearing potential, and use of adequate contraception

• hematological status: neutrophiles ≥ 1,5x10E9/L, thrombocytes ≥ 100x10E9/L

• adequate renal function: serum creatinine ≤ 1,5 x ULN

• adequate liver function: alkaline phosphatase < 2,5 x ULN, total bilirubin < 1,5 x ULN

Exclusion Criteria:

• pregnant or nursing women

• women of child-bearing potential without adequate contraception

• concomitant anti-tumoral therapy except study mandated procedures

• cervical esophageal cancer or diagnosis of metastases

• participation in other clinical trials within the last 30 days

• history of malignant disease within the last 5 years

• peripheral neuropathy (NCI CTC ≥ grade 1)

• concurrent active and serious non-malignant diseases: uncontrolled heart insufficiency, angina pectoris, hypertension or arrhythmias, liver disease, significant neurological or psychiatric conditions

• active infections