Status:
UNKNOWN
A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborating Sponsors:
Beijing Municipal Science & Technology Commission
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT01444547
Start Date
January 1 2007
End Date
December 1 2015
Last Update
May 6 2014
Active Locations (1)
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1
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China, 100021