A Phase II Clinical Trial of Docetaxel, Oxaliplatin Combination Chemotherapy in Patients With Stage IIIB/IV Non-adenocarcinoma, Non-small Cell Lung Cancer (NSCLC) as Second-line Treatment

Status: Unknown status
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

Goals The primary goal of this phase II trial is to: evaluate the response rate of combination chemotherapy with docetaxel and oxaliplatin in patients with stage IIIB/IV non-adenocarcinoma, non-small cell lung cancer (NSCLC) as second-line treatment Secondary goals are to: evaluate the treatment-related toxicities of this combination, investigate progression-free survival (PFS) and overall survival (OS) in this population Design The proposed clinical trial is an open label, non-comparative, multicenter phase II trial according to the two stage testing design by Simon two-stage testing procedure

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No
View:

• Patients who were diagnosed as non-adenocarcinoma, non-small cell carcinoma of lung histologically or cytologically

• Patients must be ≥ 18 years old of age

• ECOG performance status ≤ 1

• Estimated life expectancy of more than 3 months

• Treatment with only one prior chemotherapy

• At least one lesion that can be measured by imaging (CT/MRI) according to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

• Adequate bone marrow function (absolute neutrophil count [ANC] ≥ 1,500/µL, hemoglobin ≥ 9.0 g/dL [correction by transfusion is acceptable], and platelets ≥ 100,000/µL)

• Adequate kidney function (serum creatinine < 1.5 x upper limit of normal [ULN])

• Adequate liver function (serum total bilirubin < 1.5xULN; serum transaminases levels < 2.5xUNL)

• Provision of fully informed consent prior to any study specific procedures

Locations
Other Locations
Republic of Korea
Soonchunhyang University Cheonan Hospital
Recruiting
Cheonan
Chungbuk National University Hospital
Recruiting
Cheongju
Chungnam National University Hospital
Recruiting
Daejeon
The Catholic University of Korea Daejeon ST. Mary's Hospital
Recruiting
Daejeon
Chonbuk National University Hospital
Recruiting
Jeonju
Contact Information
Primary
Sang Byung Bae
baesan@schmc.ac.kr
+82-41-570-3667
Backup
Hwan Jung Yun
hjyun@cnu.ac.kr
+82-42-280-7157
Time Frame
Start Date: February 2011
Completion Date: December 2013
Participants
Target number of participants: 35
Authors
Sam Yong Kim, Hye Suk Han, Young Joon Yang, Sang Byung Bae, Suk Young Park, Eun-Kee Song, Hwan Jung Yun, Chang-Yeol Yim, Ji Chan Park, Na-Ri Lee, Kyu Taek Lee, Ki Hyeong Lee, Hyo Jin Lee, Han Jo Kim
Sponsors
Leads: Korean South West Oncology Group

This content was sourced from clinicaltrials.gov

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