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

NCT01497041 | Unknown Phase 2

• 1 other identifier: KSWOG 2010-3
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 5

Brief Summary

1. 1.Goals
2. 2.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

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous; Carcinoma, Large Cell

Outcome Measures

Primary Outcomes (1)

• Response rate

  Assessment of response will be assessed according to RECIST v1.1 criteria

  2years

Secondary Outcomes (4)

• Overall survival

  2years

• Progression free survival

  2 years

• Number of Participants with Adverse Events

  2 years

• Quality of life

  2 years

Interventions

Docetaxel DRUG

Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks

Oxaliplatin DRUG

Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnant or breastfeeding women and women of childbearing potential not employing adequate contraception
• Patients who received prior chemotherapy including paclitaxel or docetaxel
• Patients with second primary cancer (except, adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥5 years)
• Patients with defect of central nervous system (CNS) or any psychiatric disorders and CNS metastases
• Other serious illness or medical conditions A. Clinically significant cardiac disease (uncontrolled congestive heart disease despite treatment \[NYHA class III or IV\], symptomatic coronary artery disease, unstable angina or myocardial infarction, conduction abnormality like grade 2 AV block, serious arrhythmia needed for medication, uncontrolled hypertension) within 6 months prior to study entry B. Liver cirrhosis (≥ Child-Pugh class B) C. History of significant neurologic or psychiatric disorders including dementia or seizures D. Active uncontrolled infection E. Other serious underlying medical conditions which could impair the ability of the patient to participate in the study
• Concomitant administration of any other experimental drug under investigation, or concomitant chemotherapy, hormonal therapy, or immunotherapy

Sponsors & Collaborators

• Korean South West Oncology Group: lead

Study Sites (5)

Soonchunhyang University Cheonan Hospital

Cheonan, South Korea

RECRUITING

Chungbuk National University Hospital

Cheongju-si, South Korea

RECRUITING

Chungnam National University Hospital

Daejeon, South Korea

RECRUITING

The Catholic University of Korea Daejeon ST. Mary's Hospital

Daejeon, South Korea

RECRUITING

Chonbuk National University Hospital

Jeonju, South Korea

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Carcinoma, Squamous Cell; Carcinoma, Large Cell

Interventions

Docetaxel; Oxaliplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Study Officials

• Sang Byung Bae, M.D.

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Byung Bae

CONTACT

+82-41-570-3667; baesan@schmc.ac.kr

Hwan Jung Yun

CONTACT

+82-42-280-7157; hjyun@cnu.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2011
• First Posted: December 22, 2011
• Study Start: February 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: December 22, 2011

Record last verified: 2011-12

Locations

KR (5)