Clinical trial NCT03126708: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Esophageal Cancer, Squamous Cell
Cetuximab Effect
Chemotherapy Effect
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2017-04-24
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Progression free survival
timeFrame: 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:
measure: Overall Survival
timeFrame: 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
measure: overall response rate
timeFrame: 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
measure: Disease control rate
timeFrame: 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
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 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
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Cancer Hospital
state: Beijing
Study officials:
affiliation: Peking Universtiy Cancer Hospital
name: Lin Shen, MD
role: PRINCIPAL_INVESTIGATOR
References: