Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma

Phase 3

• Conditions: Esophageal Squamous Carcinoma
• Interventions: Drug: Paclitaxel; Radiation: Radiation therapy; Drug: Erlotinib

• Registration Number: NCT01752205
• Lead Sponsor: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Brief Summary

The purpose of this study is to test the safety and effectiveness of erlotinib and chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous cancer .

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Status Verified: 2012-12
• Study First Submitted: 2012-12-16
• Study First Submitted QC: 2012-12-16
• Last Update Submitted: 2012-12-16
• Study First Posted: 2012-12-19
• Last Update Posted: 2012-12-19
• Primary Completion: 2014-05
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

1. Histologically confirmed squamous cell carcinoma of esophagus or Esophagogastric Junction

2. Age >= 18

3. ECOG PS 0-2

4. Ineligibility for surgery

5. No prior palliative therapy

6. At least one bidimensionally measurable disease as defined by RECIST ver 1.1

7. Adequate organ function for treatment

   • Absolute neutrophil count (ANC)>=1000cells/mm3
   • Platelets >=100000 cells/mm3
   • Estimated creatinine clearance>=50mL/min, or serum creatinine<1.5 x institution upper limit of normal
   • Bilirubin=<1.5 x upper limit of normal(ULN)
   • AST(SGOT)=<2.5 x ULN (5.0xULN if hepatic metastases)
   • ALT(SGPT)=<2.5 x ULN (5.0xULN if hepatic metastases)
   • 12-Lead electrocardiogram(ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
   • QTc interval =<470 msec and without history of Torsades de Points or other symptomatic QTc abnormality
   • LVEF (by MUGA or echocardiogram) of >=50%.

8. The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.

Exclusion Criteria

1. Previous treatment with small molecule EGFR tyrosine kinase inhibitors
2. Any major operation within 4 weeks of baseline disease assessment
3. Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
4. CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
5. Patients with known interstitial lung disease
6. Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months,Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
7. Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry.
8. Pregnant or breast-feeding women
9. Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemoradiotherapy	Radiation therapy	The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w.
Erlotinib and chemoradiotherapy	Erlotinib	The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.
Erlotinib and chemoradiotherapy	Radiation therapy	The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.
Chemoradiotherapy	Paclitaxel	The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w.
Erlotinib and chemoradiotherapy	Paclitaxel	The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.

Primary Outcome Measures

Name	Time	Method
Progression free survival	2 year

Secondary Outcome Measures

Name	Time	Method
Tumor response rate	1 year
disease control rate	1 year
overall survival	5 year
adverse events	5 year

Trial Locations

Locations (1)

307 Hospital of PLA; 🇨🇳 Beijing, Beijing, China