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A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin
Conditions
Esophageal Cancer
Conditions: official terms
Esophageal Neoplasms
Conditions: Keywords
esophageal cancer, paclitaxel, cisplatin
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: paclitaxel and cisplatin
Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 70 Years
Minimum Age: 18 Years
Gender: Both
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
- 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
Location
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing, China
Status: Recruiting
Contact: Yi Zhou, M.D - 8610-87788800 - mondaycm@yahoo.com.cn
Start Date
January 2007
Completion Date
December 2015
Sponsors
Chinese Academy of Medical Sciences
Source
Chinese Academy of Medical Sciences
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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