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.
Overview
- Phase
- Phase 2
- Intervention
- cetuximab
- Conditions
- Esophageal Cancer, Squamous Cell
- Sponsor
- Peking University
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Progression free survival
- Last Updated
- 8 years ago
Overview
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.
Investigators
Shen Lin
Director,Department of GI Oncology,Peking University, School of Oncology, Beijing Cancer Hospital & Institute
Peking University
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.
- •ECOG performance status of 0 or
- •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.
Arms & Interventions
chemotherapy (cisplatin plus paclitaxel) and cetuximab
Intervention: cetuximab
chemotherapy (cisplatin plus paclitaxel) and cetuximab
Intervention: cisplatin plus paclitaxel
chemotherapy (cisplatin plus paclitaxel)
Intervention: cisplatin plus paclitaxel
Outcomes
Primary Outcomes
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 Outcomes
- 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)