A Study on Predictive Value of ERCC1 in Esophageal Cancer Patients Treated With Paclitaxel and Cisplatin
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Purpose
The purpose of this study is to evaluate the efficacy and safety of first-line chemotherapy with cisplatin and paclitaxel in esophageal cancer
| Condition | Intervention | Phase |
|---|---|---|
|
Esophageal Cancer |
Drug: paclitaxel and cisplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase Ⅱ Study on Low-expression and High-expression of ERCC1 in Recurrent or Metastastic Esophageal Cancer Patients Treated With Biweekly Paclitaxel and Cisplatin |
- Overall response rate (ORR) [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]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
- Time to event efficay [ Time Frame: 5 year ] [ Designated as safety issue: No ]
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
| Estimated Enrollment: | 92 |
| Study Start Date: | January 2007 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: single-arm Paclitaxel-Cisplatin |
Drug: paclitaxel and cisplatin
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. Other Name: Paclitaxel,Beijing Union Pharmaceutical Factory
|
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.
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: Yi Zhou, M.D | 8610-87788800 | mondaycm@yahoo.com.cn |
| Contact: Xiao Lv, M.D | 8610-87788800 | xiaoxiao81473@126.com |
| China | |
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting |
| Beijing, China, 100021 | |
| Contact: Yi Zhou, M.D 8610-87788800 mondaycm@yahoo.com.cn | |
| Contact: Xiao Lv, M.D 8610-87788800 xiaoxiao81473@126.com | |
| Principal Investigator: Jing Huang, M.D.,Ph.D | |
| Principal Investigator: | Jing Huang, M.D.,Ph.D | Cancer Institute and Hospital, Chinese Academy of Medical Sciences |
More Information
Publications:
| Responsible Party: | Jing Huang, Principle Investigator, Chinese Academy of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT01444547 History of Changes |
| Other Study ID Numbers: | CH-GI-021, Z111107058811023 |
| Study First Received: | September 28, 2011 |
| Last Updated: | October 2, 2011 |
| Health Authority: | China: Beijing Municipal Science and Technology Commission China: Ministry of Health |
Keywords provided by Chinese Academy of Medical Sciences:
|
esophageal cancer paclitaxel cisplatin |
Additional relevant MeSH terms:
|
Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Digestive System Diseases Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Head and Neck Neoplasms Cisplatin Paclitaxel |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 21, 2013