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

NCT03126708 | Unknown Phase 2

• 1 other identifier: ESCC-Cetuximab-PKU
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer, Squamous Cell; Cetuximab Effect; Chemotherapy Effect

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

Study Arms (2)

chemotherapy (cisplatin plus paclitaxel) and cetuximab

EXPERIMENTAL

Drug: cetuximab; Drug: cisplatin plus paclitaxel

chemotherapy (cisplatin plus paclitaxel)

ACTIVE COMPARATOR

Drug: cisplatin plus paclitaxel

Interventions

cetuximab DRUG

cetuximab (EGFR monoclonal antibody) plus standard chemotherapy

chemotherapy (cisplatin plus paclitaxel) and cetuximab

cisplatin plus paclitaxel DRUG

Chemotherapy

chemotherapy (cisplatin plus paclitaxel); chemotherapy (cisplatin plus paclitaxel) and cetuximab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Cancer Hospital

Beijing, Beijing Municipality, 100142, China

RECRUITING

MeSH Terms

Conditions

Esophageal Squamous Cell Carcinoma

Interventions

Cetuximab; Cisplatin; Paclitaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Lin Shen, MD

  Peking Universtiy Cancer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhihao Lu, MD

CONTACT

86-10-88196561; pppeirain@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director,Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 24, 2017
• Study Start: April 10, 2017
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2020
• Last Updated: January 4, 2018

Record last verified: 2018-01

Locations

CN (1)