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

Phase 2

• Conditions: Cetuximab Effect; Chemotherapy Effect; Esophageal Cancer, Squamous Cell
• Interventions: Drug: cetuximab; Drug: cisplatin plus paclitaxel

• Registration Number: NCT03126708
• Lead Sponsor: Peking University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-10
• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-19
• Study First Posted: 2017-04-24
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-03
• Last Update Posted: 2018-01-04
• Primary Completion: 2019-04
• Study Completion: 2020-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
chemotherapy (cisplatin plus paclitaxel) and cetuximab	cisplatin plus paclitaxel	-
chemotherapy (cisplatin plus paclitaxel)	cisplatin plus paclitaxel	-
chemotherapy (cisplatin plus paclitaxel) and cetuximab	cetuximab	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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
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
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

Trial Locations

Locations (1)

Peking University Cancer Hospital; 🇨🇳 Beijing, Beijing, China