Paclitaxel Plus Radiation With Erlotinib to Treat Esophageal Squamous Carcinoma

Esophageal Squamous Carcinoma Clinical Trial

— ESCC-307PLAH  

Official title:

A Randomized Phase III Study: Paclitaxel Plus Radiation Therapy With or Without Erlotinib in Treating Patients With Esophageal Squamous Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01752205
• Other study ID #: ESCC-307PLAH-XJM
• Status: Recruiting
• Phase: Phase 3
• First received: December 16, 2012
• Last updated: December 16, 2012
• Start date: November 2012
• Est. completion date: November 2014

Study information

• Verified date: December 2012
• Source: The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
• Contact: Xu jianming, M.D.
• Phone: 861051128358
• Email: jmxu2003[@]yahoo.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: November 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Esophageal Squamous Carcinoma

Intervention

Drug:
• Paclitaxel
45mg/m2/w,total 6 weeks
• Erlotinib
150mg/d,days 1-42,total 6 weeks

Radiation:
• Radiation therapy

Locations

Country	Name	City	State
China	307 Hospital of PLA	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		2 year	Yes
Secondary	Tumor response rate		1 year	Yes
Secondary	disease control rate		1 year	Yes
Secondary	overall survival		5 year	Yes
Secondary	adverse events		5 year	Yes