Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma

Chemotherapy Effect Clinical Trial

Official title:

A Phase II, Multicenter, Open-Label, Randomized, Controlled Study to Assess Efficacy and Safety of Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Chinese Subjects With Metastatic Esophageal Squamous Cell Carcinoma.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03126708
• Other study ID #: ESCC-Cetuximab-PKU
• Status: Recruiting
• Phase: Phase 2
• First received: April 12, 2017
• Last updated: January 3, 2018
• Start date: April 10, 2017
• Est. completion date: April 2020

Study information

• Verified date: January 2018
• Source: Peking University
• Contact: Zhihao Lu, MD
• Phone: 86-10-88196561
• Email: pppeirain[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, randomized, controlled trial. At the end of a 28-day screening period, all eligible subjects will be randomly assigned into treatment Arm A or B in a 1:1 ratio. Subjects in Arm A will receive a maximum of 6 cycles of chemotherapy (cisplatin plus paclitaxel) and cetuximab weekly in the absence of progressive disease (PD), as assessed by the Investigator, and unacceptable toxicity. After 6 cycles of treatment, subjects who derive clinical benefit will continue treatment with cetuximab as monotherapy until either PD or unacceptable toxicity. Subjects in Arm B will receive the same chemotherapy regimen as Arm A alone for a maximum of 6 cycles in the absence of PD and unacceptable toxicity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2020
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• Inclusion Criteria:

• Signed written informed consent.

• Older than 18 years of age.

• Histologically proven squamous cell carcinoma of the esophagus.

• Metastatic ESCC, not suitable for local-regional treatment.

• Presence of at least 1 measurable lesion according to RECIST version 1.1.

• ECOG performance status of 0 or 1.

• Adequate bone marrow, haptic, renal, metabolic function.

• Exclusion Criteria:

• Prior chemotherapy in the metastasis setting.

• Prior chemotherapy within 6 months before entering this study.

• Previous exposure to EGFR-targeted therapy.

• Known central nervous system metastasis and/or leptomeningeal disease.

• Subjects with any concurrent medical condition or disease that will potentially compromise the conduct of the trial at the discretion of investigator.

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Cetuximab Effect
• Chemotherapy Effect
• Esophageal Cancer, Squamous Cell
• Esophageal Neoplasms
• Neoplasms, Squamous Cell

Intervention

Drug:
• cetuximab
cetuximab (EGFR monoclonal antibody) plus standard chemotherapy
• cisplatin plus paclitaxel
Chemotherapy

Locations

Country	Name	City	State
China	Peking University Cancer Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Overall Survival		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary	overall response rate		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Disease control rate		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0		From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months