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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


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Esophageal Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR)

Outcome Description:

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

Outcome Time Frame:

5 year

Safety Issue:

Yes

Principal Investigator

Jing Huang, M.D.,Ph.D

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Authority:

China: Beijing Municipal Science and Technology Commission

Study ID:

CH-GI-021

NCT ID:

NCT01444547

Start Date:

January 2007

Completion Date:

October 2013

Related Keywords:

  • Esophageal Cancer
  • esophageal cancer
  • paclitaxel
  • cisplatin
  • Esophageal Diseases
  • Esophageal Neoplasms

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