Back to resultsCetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma
Primary Purpose
Esophageal Cancer, Squamous Cell, Cetuximab Effect, Chemotherapy Effect
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
cetuximab
cisplatin plus paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Esophageal Cancer, Squamous Cell
Eligibility Criteria
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.
Sites / Locations
- Peking University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
chemotherapy (cisplatin plus paclitaxel) and cetuximab
chemotherapy (cisplatin plus paclitaxel)
Arm Description
Outcomes
Primary Outcome Measures
Progression free survival
Secondary Outcome Measures
Overall Survival
overall response rate
Disease control rate
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03126708
Brief Title
Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 10, 2017 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esophageal Cancer, Squamous Cell, Cetuximab Effect, Chemotherapy Effect
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
chemotherapy (cisplatin plus paclitaxel) and cetuximab
Arm Type
Experimental
Arm Title
chemotherapy (cisplatin plus paclitaxel)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
cetuximab
Intervention Description
cetuximab (EGFR monoclonal antibody) plus standard chemotherapy
Intervention Type
Drug
Intervention Name(s)
cisplatin plus paclitaxel
Intervention Description
Chemotherapy
Primary Outcome Measure Information:
Title
Progression free survival
Time Frame
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 Measure Information:
Title
Overall Survival
Time Frame
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
Title
overall response rate
Time Frame
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
Title
Disease control rate
Time Frame
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
Title
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time Frame
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhihao Lu, MD
Phone
86-10-88196561
Email
pppeirain@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Organizational Affiliation
Peking Universtiy Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Cancer Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100142
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Shen, MD
Phone
+86-10-88196561
Email
lin100@medmail.com.cn
12. IPD Sharing Statement
Learn more about this trial
Cetuximab in Combination With Paclitaxel Plus Cisplatin Versus Paclitaxel Plus Cisplatin Alone for the First-line Treatment of Metastatic Esophageal Squamous Cell Carcinoma
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