Esophageal Cancer
Conditions
Keywords
esophageal cancer, paclitaxel, cisplatin
Brief summary
The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer
Detailed description
Open label single arm phase II study of cisplatin and paclitaxel in patients with recurrent or metastatic esophageal cancer. 92 Patients will be enrolled in this local trial. The primary objective of this study is to determine the response rate of the treatment.Schedule for this study is as follows: paclitaxel 150 mg/m2 will be administered as an intravenous infusion over 3 hour on Days 1, followed by cisplatin 50 mg/m2 on Days 2. This study will also include the investigation of ERCC1 expression in order to assess determinants of efficacy of the treatment with cisplatin and paclitaxel in the study population.
Interventions
Paclitaxel 150 mg/m2 will be administered as an intravenous (IV) infusion over 3 hour on Days 1; Cisplatin 50 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day. 14 days as a cycle, up to 8 cycles.
Sponsors
Beijing Municipal Science & Technology Commission
Chinese Academy of Medical Sciences
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Histologically proven diagnosis of the squamous cell carcinoma or adenocarcinoma of esophagus * locally advanced, recurrent or metastatic disease * Performance Status of 0-2 on the Eastern Cooperative Oncology Group (ECOG) performance status Scale * Previous adjuvant or pre-operative chemotherapy without containing paclitaxel or platinum at least 12 months before enrollment * Adequate organ function including the following: Bone marrow: absolute neutrophil count (ANC) \>or equal to 1.5 \* 109/L, platelets \>or equal to 100 \*109/L, hemoglobin \> or equal to 10 g/dL. Hepatic: bilirubin \< or equal to 1.5 x ULN; alkaline phosphatase, aspartate transaminase (AST) and alanine transaminase (ALT) \< or equal to 3 x ULN (alkaline phosphatase, AST, ALT minor or equal to 5 x ULN is acceptable if liver has tumor involvement), serum albumin \> or equal to3g/dL. Renal: Calculated creatinine clearance major or equal to 60 ml/min (using the standard Cockcroft-Gault formula).
Exclusion criteria
* No Prior palliative chemotherapy for advanced disease * Previous radiation therapy is allowed but should have been limited and must not have included whole pelvis radiation. Patients must have recovered from the toxic effects of the treatment prior to study enrollment (except for alopecia). Prior radiotherapy must be completed at least 30 days before study enrollment * Known or suspected brain metastasis * Second primary malignancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall response rate (ORR) | 5 year | The primary objective of this study is to determine the response rate of paclitaxel plus cisplatin as first-line therapy in patients with locally advanced, recurrent or metastatic esophageal carcinoma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to event efficay | 5 year | The following time to event efficacy measures: * Duration of overall response for responding patients * Time to documented progressive disease * Overall survival * The quantitative and qualitative toxicity of paclitaxel plus cisplatin. * Determinant of efficacy of the treatment with paclitaxel and cisplatin in the patient population by means of the analysis of ERCC1 |
Countries
China
Contacts
Primary ContactYi Zhou, M.D
Backup ContactXiao Lv, M.D
Outcome results
None listed