Overview

A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin

Status:
Unknown status
Trial end date:
2015-12-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Chinese Academy of Medical Sciences
Collaborator:
Beijing Municipal Science & Technology Commission
Treatments:
Albumin-Bound Paclitaxel
Cisplatin
Paclitaxel
Criteria
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