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Trial Title:
A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin
NCT ID:
NCT01444547
Condition:
Esophageal Cancer
Conditions: Official terms:
Esophageal Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Conditions: Keywords:
esophageal cancer
paclitaxel
cisplatin
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
paclitaxel and cisplatin
Description:
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.
Arm group label:
single-arm Paclitaxel-Cisplatin
Other name:
Paclitaxel,Beijing Union Pharmaceutical Factory
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Address:
City:
Beijing
Zip:
100021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yi Zhou, M.D
Phone:
8610-87788800
Email:
mondaycm@yahoo.com.cn
Contact backup:
Last name:
Xiao Lv, M.D
Phone:
8610-87788800
Email:
xiaoxiao81473@126.com
Investigator:
Last name:
Jing Huang, M.D.,Ph.D
Email:
Principal Investigator
Start date:
January 2007
Completion date:
December 2015
Lead sponsor:
Agency:
Chinese Academy of Medical Sciences
Agency class:
Other
Collaborator:
Agency:
Beijing Municipal Science & Technology Commission
Agency class:
Other
Source:
ChineseAMS
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01444547
