Phase II, Multicentre, Uncontrolled Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Chemotherapy (Docetaxel, Cisplatin, 5-fluorouracil) as Neoadjuvant Therapy Followed Concomitant Chemoradiotherapy (Cisplatin) Plus Cetuximab in Patients With a Locoregional Esophageal Carcinoma

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)1 site in 1 country50 target enrollmentDecember 2006

ConditionsEsophageal Carcinoma

Interventionscetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)

Drugscetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)

Overview

Phase: Phase 2
Intervention: cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)
Conditions: Esophageal Carcinoma
Sponsor: Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)
Enrollment: 50
Locations: 1
Primary Endpoint: • Complete clinical response rate and objective clinical response rate after the administration of 3 cycles of chemotherapy plus cetuximab and after induction chemotherapy followed by concomitant chemoradiotherapy plus cetuximab
Status: Completed
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to determine efficacy ans safety of the combination of cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant therapy followed concomitant chemoradiotherapy (cisplatin) plus cetuximab in patients with a locoregional esophageal carcinoma

Registry

clinicaltrials.gov

Start Date

December 2006

End Date

November 2012

Last Updated

13 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Spanish Cooperative Group for the Treatment of Digestive Tumours (TTD)

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Informed consent form signed before performing any of the study's specific procedures.
•Age \> 18 and \<
•Karnofsky performance status \> 70% upon inclusion in the study.
•Life expectancy of more than 3 months.
•Histologically confirmed diagnosis of squamous cell carcinoma or adenocarcinoma of the oesophagus or the gastroesophageal junction. The disease must be confined to the oesophagus or gastroesophageal junction and the perioesophageal region. There must be no tumor extension beyond 2 cm into the stomach.
•Stages II or III. The patients must have a T1N1M0 or T2-4; any N; M
•The only exception would be patients with stage IVA: an oesophageal carcinoma of the upper thoracic region with metastasis in cervical lymph nodes (M1a) and an oesophageal carcinoma of the lower thoracic region with metastasis in the celiac lymph nodes (M1a), providing the disease remains within the radiotherapy fields.
•Presence of a unidimensionally measurable and/or assessable lesion
•Neutrophils \>1500/mm3, platelet count \>150,000/mm3 and haemoglobin \>10 g/dl.
•Adequate renal function: serum creatinine \< 120 micromol/l (1.4 mg/dl); if the values are \>120 micromol/l (1.4 mg/dl) creatinine clearance must be \> 65 ml/min.

Exclusion Criteria

•Patients with a tracheo-oesophageal fistula or direct invasion of the tracheal mucosa or a major bronchi are not eligible. Bronchoscopy (with biopsy and cytology if lesion is seen) is required in order to rule out a fistula and/or direct invasion if the primary tumour is \< than 30 cm from the incisors. Bronchoscopy is also required when the primary tumour is shown to be at or above the carina by an imaging study.
•Prior thoracic radiotherapy and/or systemic chemotherapy and/or oesophageal surgery.
•Patients with multiple carcinoma of the oesophagus.
•Diagnosis of any other cancer in the previous 5 years with the exception of appropriately treated carcinoma in situ of the uterine cervix and/or basal cell carcinoma of the skin.
•Systemic, chronic and concomitant immune treatment, or anti-cancer hormone therapy.
•Other concomitant cancer treatments.
•Active infection (infection requiring intravenous antibiotics), including active tuberculosis and diagnosed HIV.
•Uncontrolled hypertension defined as systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 130 mmHg at rest.
•Active, uncontrolled, gastric or duodenal peptic ulcer.
•Chronic obstructive pulmonary disease requiring hospitalisation in the 6 months prior to inclusion in the study.

Arms & Interventions

1

Intervention: cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil)

Outcomes

Primary Outcomes

• Complete clinical response rate and objective clinical response rate after the administration of 3 cycles of chemotherapy plus cetuximab and after induction chemotherapy followed by concomitant chemoradiotherapy plus cetuximab

Time Frame: 2006-2010

Secondary Outcomes

• To determine the complete pathological response rate in the patients subject to radical surgery, according to the investigators' criteria and the policy of each centre.(2006-2010)
Adverse events(2006-2010)
• To study the locoregional control of the disease, the therapeutic failure patterns, specific disease-free survival, event-free survival, disease-specific survival and global survival(2006-2012)
• To determine EGFR expression in the tumour and attempt to correlate it with efficacy(2006-2010)